TERM PAPER onEVIDENCE BASED PRACTICES in OBSTETRICS AND GYNAECOLOGYSubmitted to :Mrs.Sonia R B D’Souza Assistant Professor MCON Manipal.

Submitted by: Ms.Sharmila Jose 1st year Msc.Nursing MCON Manipal Submitted on : 25/3/10.

. INDEX

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Sl No TOPIC Page number1. Introduction2. Evidence based practices in Gynaecology3. Evidence based practices in Pregnancy,labour

and Puerperium4. Evidence based practices in Neonatology

EVIDENCE BASED PRACTICES IN OBSTETRICAL AND GYNAECOLOGICAL NURSING "Knowing is not enough; we must apply. Willing is not enough, we must do" (The Cicily statement on evidence-based practice)INTRODUCTION

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Within the nursing profession, it is expected that new information in the form of research findings will be incorporated constantly and knowledgeably into nursing practice. The staff nurse is a critical link in bringing research-based changes into clinical practice. Depending on the environment, a health care organization may or may not have the resources to ensure critical, succinct, reasonable evaluation and application of research findings as they relate to the point-of-care delivery. Health care organizations are beginning to create mechanisms to facilitate the process of information translation from the literature to practice. Evidence based practice is sometimes indicative of an attempt to avoid the ‘nature’ of the evidence being detained by the bias of a particular professional grouping. The emphasis is on practice and this determines the nature of evidence that would be sought. The ability to deliver evidence-based practice promotes individualisation of care and assures the quality of health care for patients today as well as those of tomorrow Critical thinking is vital to evidence-based nursing practice. Evidence-based practice (EBP) supports nursing care and can contribute positively to patient outcomes across a variety of settings and geographic locations. The nature of EBP, its relevance to nursing, and the skills needed to support it should be required components of baccalaureate education and must be introduced early in students' development as independent, self-directed learners and as professional nurses. Among the knowledge, skills, and processes needed to support EBP, Critical thinking is paramount. STEPS OF EVIDENCE BASED PRACTICE

Asking the relevant clinical question Searching for the best evidence Appraising the evidence critically Integrating evidence with clinical expertise, patient preferences and values in making a

practice decision or change Evaluating the practice decision on change

EVIDENCE BASED PRACTICES IN GYNAECOLOGY

1)Skin patch and vaginal ring versus combined oral contraceptives for contraceptionLaureen M Lopez, David A Grimes, Maria F Gallo, Kenneth F Schulz

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ObjectivesTo compare the contraceptive effectiveness, cycle control, adherence (compliance), and safety of the skin patch or the vaginal ring versus combination oral contraceptives (COCs).

Selection criteriaAll randomized controlled trials comparing the skin patch or vaginal ring with a COC.

Data collection and analysisData were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the mean difference was computed.

Main resultsThe researchers found 5 trials of the skin patch and 10 of the vaginal ring. Contraceptive effectiveness was similar for the patch or ring versus the comparison COC. More patch users discontinued early than COC users: ORs were 1.59 (95% CI 1.26 to 2.00), 1.56 (95% CI 1.18 to 2.06), and 2.57 (95% CI 0.99 to 6.64). Patch users also had more discontinuation due to adverse events. Compared to COC users, patch users reported more breast discomfort, dysmenorrhea, nausea, and vomiting. Patch users reported more compliant cycles than the COC users in two trials: ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24). The ring trials generally showed similar discontinuation for ring and COC users. Ring users reported less nausea, acne, irritability, and depression than COC users. Ring users had more vaginitis and leukorrhea but less vaginal dryness. Ring users had similar adherence to COC users in two trials but less adherence in one. Cycle control was generally similar for the patch and COC, and was similar or better for the ring versus COC.

ConclusionsEffectiveness was similar for the methods compared. The patch could lead to more discontinuation while the vaginal ring showed little difference. The patch group had better compliance than the COC group but more side effects. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. High losses to follow up can affect the validity of the results.

2) Conservative management of pelvic organ prolapse in womenSuzanne Hagen, Diane Stark, Christopher Maher, Elisabeth J Adams

ObjectivesTo determine the effects of conservative management (physical interventions and lifestyle interventions) for women with pelvic organ prolapse in comparison with no treatment or other treatment options (such as mechanical devices or surgery).

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Selection criteriaRandomised and quasi-randomised trials in women with pelvic organ prolapse that included a physical or lifestyle intervention in at least one arm of the trial.

Data collection and analysisTwo reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions.

Main resultsThree trials of relevance to this review were identified. The largest of these, of pelvic floor muscle training in preventing anterior prolapse from worsening, had significant limitations which affect the generalisability and rigor of the findings. A small feasibility study (which is to be followed up with a larger trial) randomised 47 women to pelvic floor muscle training or control and found suggestions of better outcomes (better self-reported improvement, decreased severity) in the intervention group. The third trial evaluated peri-operative physiotherapy for women undergoing surgery for prolapse and/or incontinence. The authors report that urinary symptoms, pelvic floor muscle function and quality of life were improved more in the treatment group than the control group, but data were not provided to allow this to be assessed. The trial was small and no prolapse-specific outcome measures were used. It was not possible to combine data from the three trials.

ConclusionsDespite there now being reports of three eligible trials in this update, the evidence available is not significant to guide practice. There is some encouragement from a feasibility study that pelvic floor muscle training, delivered by a physiotherapist to symptomatic women in an outpatient setting, may reduce severity of prolapse. Further evidence from larger, better quality randomised control trials is however still necessary.

3) Advance provision of emergency contraception for pregnancy preventionChelsea B. Polis, David A Grimes, Kate Schaffer, Kelly Blanchard, Anna Glasier, Cynthia Harper

Objectives

The objectives of the study was to to summarize randomized controlled trials evaluating advance provision of emergency contraception to explore effects on pregnancy rates, sexually transmitted infections, and sexual and contraceptive behaviors.

Selection criteria

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The researchers included randomized controlled trials comparing advance provision and standard access (i.e., counseling which may or may not have included information about emergency contraception, or provision of emergency contraception on request at a clinic or pharmacy).

Main resultsEleven randomized controlled trials met our criteria for inclusion, representing 7695 patients in the United States, China, India and Sweden. Advance provision did not decrease pregnancy rates (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.76 to 1.25 in studies for which we included twelve-month follow-up data; OR 0.48, 95% CI 0.18 to 1.29 in a study with seven-month follow-up data; OR 0.92, 95% CI 0.70 to 1.20 in studies for which we included six-month follow-up data; OR 0.49, 95% CI 0.09 to 2.74 in a study with three-month follow-up data), despite reported increased use (single use: OR 2.47, 95% CI 1.80 to 3.40; multiple use: OR 4.13, 95% CI 1.77 to 9.63) and faster use (weighted mean difference (WMD) -12.98 hours, 95% CI -16.66 to -9.31 hours). Advance provision did not lead to increased rates of sexually transmitted infections (OR 1.01, 95% CI 0.75 to 1.37), increased frequency of unprotected intercourse, or changes in contraceptive methods. Women who received emergency contraception in advance were equally likely to use condoms as other women.

ConclusionsAdvance provision of emergency contraception did not reduce pregnancy rates when compared to conventional provision. Results from primary analyses suggest that advance provision does not negatively impact sexual and reproductive health behaviors and outcomes. Women should have easy access to emergency contraception, because it can decrease the chance of pregnancy. However, the interventions tested thus far have not reduced overall pregnancy rates in the populations studied.

4)Acupuncture for uterine fibroidsYan Zhang, Weina Peng, Jane Clarke, Zhishun Liu

ObjectivesTo assess the benefits and harms of acupuncture in women with uterine fibroids

Selection criteriaAll randomised controlled trials (RCTs) comparing acupuncture management with placebo acupuncture, no management, Chinese medication, Western medication or other managements of uterine fibroids were considered for inclusion. Acupuncture management included either traditional acupuncture or contemporary acupuncture, regardless of the source of stimulation (for example, body, electro, scalp, elongated, fire, hand, fine needle, moxibustion). Acupuncture management without needling was excluded.

Data collection and analysisTwo review authors assessed trial risk of bias according to our a priori criteria. No trials were included in this version of the review, therefore no data was collected.

Main results

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No randomized double-blind controlled trials met the inclusion criteria .

ConclusionsThe effectiveness of acupuncture for the management of uterine fibroids remains uncertain. More evidence is required to establish the efficacy and safety of acupuncture for uterine fibroids.There is a continued need for well designed RCTs with long term follow up.

5) Progesterone for premenstrual syndromeOlive Ford, Anne Lethaby, Helen Roberts, Ben Willem J Mol

ObjectivesThe objectives were to determine if progesterone has been found to be an effective treatment for all or some premenstrual symptoms and if adverse events associated with this treatment have been reported.

Selection criteriaWe included randomised double-blind, placebo-controlled trials of progesterone on women with PMS diagnosed by at least two prospective cycles, without current psychiatric disorder.

Data collection and analysisTwo reviewers (BM and OF) extracted data independently and decided which trials to include. OF wrote to trial investigators for missing data.

Main resultsFrom 17 studies, only two met our inclusion criteria. Together they had 280 participants aged between 18 and 45 years. One hundred and fifteen yielded analysable results. Both studies measured symptom severity using subjective scales. Differing in design, participants, dose of progesterone and how delivered, the studies could not be combined in meta-analysis. Adverse events which may or may not have been side effects of the treatment were described as mild.Both trials had defects. They I ntended to exclude women whose symptoms continued after their periods. When data from ineligible women were excluded from analysis in one trial, the other women were found to have benefited more from progesterone than placebo. The smaller study found no statistically significant difference between oral progesterone, vaginally absorbed progesterone and placebo, but reported outcomes incompletely.

ConclusionsThe trials did not show that progesterone is an effective treatment for PMS nor that it is not. Neither trial distinguished a subgroup of women who benefited, nor examined claimed success with high doses. 6) Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushesAlastair H MacLennan, Jessica L Broadbent, Sue Lester, Vivienne Moore

Objectives

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To examine the effect of oral HT compared to placebo on these vasomotor symptoms and the risk of early onset side-effects.

Selection criteriaDouble-blind, randomised, placebo-controlled trials of oral HT for at least three months duration.

Data collection and analysisStudy quality and outcome data were assessed independently. Random effects models were considered appropriate due to the variety of trial methodologies. The meta-analyses were explored for sensitivity to trial quality and therapy duration. Symptom frequency and severity were assessed separately, together with withdrawals and side-effects. Frequency data were analysed using the Weighted Mean Difference (WMD) between treatment and placebo outcomes. For severity data, odds ratios were estimated from the proportional odds model. From 115 references originally identified, 24 trials meeting the selection criteria were included in the review. Study participants totaled 3,329. Trial duration ranged from three months to three years.

Main resultsThere was a significant reduction in the weekly hot flush frequency for HT compared to placebo (WMD -17.92, 95% CI -22.86 to -12.99). This was equivalent to a 75% reduction in frequency (95% CI 64.3 to 82.3) for HT relative to placebo. Symptom severity was also significantly reduced compared to placebo (OR 0.13, 95% CI 0.07 to 0.23). Withdrawal for lack of efficacy occurred significantly more often on placebo therapy (OR 10.51, 95% CI 5.00 to 22.09). Withdrawal for adverse events, commonly breast tenderness, oedema, joint pain and psychological symptoms, was not significantly increased (OR 1.25, 95% CI 0.83 to 1.90), although the occurrence of any adverse events was significantly increased for HT (OR 1.41, 95% CI 1.00 to 1.99). In women who were randomised to placebo treatment, a 57.7% (95% CI 45.1 to 67.7) reduction in hot flushes was observed between baseline and end of study.

ConclusionsOral HT is highly effective in alleviating hot flushes and night sweats. Therapies purported to reduce such symptoms must be assessed in blinded trials against a placebo or a validated therapy because of the large placebo effect seen in well conducted randomised controlled trials, and also because during menopause symptoms may fluctuate and after menopause symptoms often decline. Withdrawals due to side-effects were only marginally increased in the HT groups despite the inability to tailor HT in these fixed dose trials. Comparisons of hormonal doses, product types or regimens require analysis of trials with these specific "within study" comparisons.

7) Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush)Munira Nurbhai, Jeremy Grimshaw, Margaret Watson, Christine M Bond, Jill A Mollison, Anne Ludbrook

Objectives

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The primary objective of this review was to assess the relative effectiveness of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. The secondary objectives of the review were to assess the cost-effectiveness, safety and patient preference of oral versus intra-vaginal anti-fungals.

Selection criteriaRandomised controlled trials published in any language. Trials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. Women (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. The diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). Trials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. The primary outcome measure was clinical cure.

Data collection and analysisTwo reviewers screened titles and abstracts of the electronic search results and full text of potentially relevant papers. Independent duplicate abstraction was performed by two reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the fixed effects models (except for two analyses when random effects models were used because of potentially important heterogeneity).

Main resultsTwo new trials reporting three comparisons were found in the update. Nineteen trials are included in the review, reporting 22 oral versus intra-vaginal anti-fungal comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short term (OR 0.94, 95% CI, 0.75 to 1.17) and long term (OR 1.07, 95% CI, 0.82 to 1.41) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.15, 95% CI, 0.94 to 1.42). There was a statistically significant difference for long term follow-up (OR 1.29, 95% CI, 1.05 to 1.60) in favour of oral treatment, however the clinical significance of this result is uncertain. Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported.

Conclusions

No statistically significant differences were observed in clinical cure rates of anti-fungals administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal candidiasis. No definitive conclusion can be made regarding the relative safety of oral and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis. The decision to prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal administration should take into consideration: safety, cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or

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contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.

8) Cervical cap versus diaphragm for contraceptionMaria F Gallo, David A Grimes, Kenneth F Schulz, Laureen M Lopez

ObjectivesTo compare the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm.

Selection criteriaAll randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion.

Data collection and analysisArticles identified for inclusion were independently abstracted by two reviewers. Data were entered into RevMan, and a second reviewer verified the data entered. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were calculated as Peto odds ratios (OR) with 95% confidence intervals (CI). Life-table and Kaplan-Meier cumulative rate ratios for selected measures are presented.

Main resultsThe curves for the life-table cumulative pregnancy rates for the Prentif cap and the diaphragm did not differ. However, the Kaplan-Meier six-month cumulative pregnancy rates for the FemCap and the diaphragm were not clinically equivalent. The Prentif cap had more Class I to Class III cervical cytologic conversions than the diaphragm (OR 2.31; 95% CI 1.04 to 5.11). The FemCap trial did not find differences in Papanicolaou smear results between the groups. Fewer Prentif cap users had vaginal ulcerations or lacerations (OR 0.31; 95% CI 0.14 to 0.71) than diaphragm users. Fewer FemCap users had blood in the device (OR 2.29; 95% CI 1.27 to 4.14), but more had urinary tract infections (OR 0.59; 95% CI 0.39 to 0.95). In the FemCap trial, similar proportions of women reported liking their device. However, FemCap users were less likely to use the device alone after the trial (OR 0.47; 95% CI 0.31 to 0.71) or recommend it to a friend (OR 0.48; 95% CI 0.29 to 0.81).

ConclusionsThe Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

9) Adjuvant platinum-based chemotherapy for early stage cervical cancerDaniela D Rosa, Lídia RF Medeiros, Maria I Edelweiss, Mary C Bozzetti, Paula R Pohlmann, Airton T Stein, Heather O Dickinson

Objectives

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To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer (stages IA2, IB1 or IIA).

Selection criteria

Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer were included.

Data collection and analysisTwo review authors extracted data independently to assess whether the studies met the specified inclusion criteria. Any discrepancies were solved by a third and a forth review author. Meta-analysis was performed using a random effects model, with death and disease progression as outcomes.

Main resultsThree trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI: 0.30 to 0.74), with no heterogeneity between trials (I2 = 0% for both meta-analyses). One trial assessing 71 participants compared chemotherapy followed by radiotherapy with radiotherapy alone and found no significant difference between the two groups (HR = 1.34; 95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months.

ConclusionsThe addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in the adjuvant treatment of early stage cervical cancer with risk factors for recurrence. However, the evidence is limited because the selected studies were quantitatively and qualitatively limited, with small number of patients and limited period of follow-up

10) Long versus short course treatment with Metformin and Clomiphene Citrate for ovulation induction in women with PCOSupat Sinawat, Pranom Buppasiri, Pisake Lumbiganon, Porjai Pattanittum

ObjectivesTo determine the effectiveness of short-course (less than four weeks) metformin plus CC versus long-course (four weeks or more) metformin plus CC with regard to ovulation and achievement of pregnancy in infertile PCOS women.

Selection criteria

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Randomised controlled trials comparing short-course (less than four weeks) metformin plus CC versus long-course (four weeks or more) metformin plus CC for ovulation or achievement of pregnancy in infertile PCOS women.

Data collection and analysisNo trials were found that met the selection criteria.

Main resultsNo randomised controlled trials were identified.

ConclusionsThere are insufficient data to determine whether short-chouse metformin pretreatment is as effective as the conventional long-course metformin pretreatment before initiation of clomiphene citrate for ovulation induction in infertile PCOS patients. A well-designed randomised controlled trial is needed to answer this important clinical question.

EVIDENCE BASED PRACTICES IN PREGNANCY,LABOUR AND PUERPERIUM

1) Immersion in water in labour and birthElizabeth R Cluett, Ethel Burns

ObjectivesTo assess the evidence from randomised controlled trials about immersion in water during labour and waterbirth on maternal, fetal, neonatal and caregiver outcomes.

Selection criteriaRandomised controlled trials comparing any bath tub/pool with no immersion during labour and/or birth.

Main results

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This review includes 11 trials (3146 women); eight related to the first stage of labour, one to the first and second stages, one to early versus late immersion in the first stage of labour, and another to the second stage. We identified no trials evaluating different baths/pools, or the management of third stage of labour.

Results for the first stage of labour showed there was a significant reduction in the epidural/spinal/paracervical analgesia/anaesthesia rate amongst women allocated to water immersion compared to controls (478/1254 versus 529/1245; odds ratio (OR) 0.82, 95% confidence interval (CI) 0.70 to 0.98, six trials). There was no difference in assisted vaginal deliveries (OR 0.84, 95% CI 0.66 to 1.06, seven trials), caesarean sections (OR 1.23, 95% CI 0.86 to 1.75, eight trials), perineal trauma or maternal infection. There were no differences for Apgar score less than seven at five minutes (OR 1.59, 95% CI 0.63 to 4.01, five trials), neonatal unit admissions (OR 1.06, 95% CI 0.70 to 1.62, three trials), or neonatal infection rates (OR 2.01, 95% CI 0.50 to 8.07, five trials).A lack of data for some comparisons prevented robust conclusions. Further research is needed.

ConclusionsEvidence suggests that water immersion during the first stage of labour reduces the use of epidural/spinal analgesia. There is limited information for other outcomes related to water use during the first and second stages of labour, due to intervention and outcome variability. There is no evidence of increased adverse effects to the fetus/neonate or woman from labouring in water or waterbirth. The fact that use of water immersion in labour and birth is now a widely available care option for women threatens the feasibility of a large, multicentre randomised controlled trial.

2)Amniotomy for shortening spontaneous labourRebecca MD Smyth, S Kate Alldred, Carolyn Markham

ObjectivesTo determine the effectiveness and safety of amniotomy alone for (1) routinely shortening all labours that start spontaneously, and (2) shortening labours that have started spontaneously, but have become prolonged.

Selection criteriaRandomised controlled trials comparing amniotomy alone versus intention to preserve the membranes. We excluded quasi-randomised trials.

Main resultsWe have included 14 studies in this review, involving 4893 women. There was no clear statistically significant difference between the amniotomy and control groups in length of the first stage of labour (weighted mean difference -20.43 minutes, 95% confidence interval (CI) -95.93 to 55.06), caesarean section (RR 1.26, 95% CI 0.98 to 1.62), maternal satisfaction with childbirth experience (standardised mean difference 0.27, 95% CI -0.49 to 1.04) or low Apgar

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score less than seven at five minutes (RR 0.55, 95% CI 0.29 to 1.05). There was no consistency between papers regarding the timing of amniotomy during labour in terms of cervical dilatation.

ConclusionsOn the basis of the findings of this review, we cannot recommend that amniotomy should be introduced routinely as part of standard labour management and care. We do recommend that the evidence presented in this review should be made available to women offered an amniotomy and may be useful as a foundation for discussion and any resulting decisions made between women and their caregivers.

3)Midwife-led versus other models of care for childbearing womenMarie Hatem, Jane Sandall, Declan Devane, Hora Soltani, Simon Gates

ObjectivesTo compare midwife-led models of care with other models of care for childbearing women and their infants.

Selection criteriaAll published and unpublished trials in which pregnant women are randomly allocated to midwife-led or other models of care during pregnancy, and where care is provided during the ante and intrapartum period in the midwife-led model.

Main resultsWe included 11 trials (12,276 women). Women who had midwife-led models of care were less likely to experience antenatal hospitalisation, risk ratio (RR) 0.90, 95% confidence interval (CI) 0.81 to 0.99), regional analgesia (RR 0.81, 95% CI 0.73 to 0.91), episiotomy (RR 0.82, 95% CI 0.77 to 0.88), and instrumental delivery (RR 0.86, 95% CI 0.78 to 0.96), and were more likely to experience no intrapartum analgesia/anaesthesia (RR 1.16, 95% CI 1.05 to 1.29), spontaneous vaginal birth (RR 1.04, 95% CI 1.02 to 1.06), feeling in control during childbirth (RR 1.74, 95% CI 1.32 to 2.30), attendance at birth by a known midwife (RR 7.84, 95% CI 4.15 to 14.81) and initiate breastfeeding (RR 1.35, 95% CI 1.03 to 1.76), although there were no statistically significant differences between groups for caesarean births (RR 0.96, 95% CI 0.87 to 1.06). Women who were randomised to receive midwife-led care were less likely to experience fetal loss before 24 weeks' gestation (RR 0.79, 95% CI 0.65 to 0.97), although there were no statistically significant differences in fetal loss/neonatal death of at least 24 weeks (RR 1.01, 95% CI 0.67 to 1.53) or in fetal/neonatal death overall (RR 0.83, 95% CI 0.70 to 1.00). In addition, their babies were more likely to have a shorter length of hospital stay (mean difference -2.00, 95% CI -2.15 to -1.85).

ConclusionsMost women should be offered midwife-led models of care and women should be encouraged to ask for this option although caution should be exercised in applying this advice to women with substantial medical or obstetric complications.

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4) Home-like versus conventional institutional settings for birthEllen D Hodnett, Soo Downe, Nadine Edwards, Denis Walsh

ObjectivePrimary: to assess the effects of care in a home-like birth environment compared to care in a conventional labour ward. Secondary: to determine if the effects of birth settings are influenced by staffing or organizational models or geographical location of the birth centre.

Search strategyWe searched the Cochrane Pregnancy and Childbirth Group trials register (18 May 2004) and handsearched eight journals and two published conference proceedings.

Selection criteriaAll randomized or quasi-randomized controlled trials that compared the effects of a home-like institutional birth environment to conventional hospital care.

Main resultsSix trials involving 8677 women were included. No trials of freestanding birth centres were found. Between 29% and 67% of women allocated to home-like settings were transferred to standard care before or during labour. Allocation to a home-like setting significantly increased the likelihood of: no intrapartum analgesia/anaesthesia (four trials; n = 6703; relative risk (RR) 1.19, 95% confidence interval (CI) 1.01 to 1.40), spontaneous vaginal birth (five trials; n = 8529; RR 1.03, 95% CI 1.01 to 1.06), vaginal/perineal tears (four trials; n = 8415; RR 1.08, 95% CI 1.03 to 1.13), preference for the same setting the next time (one trial; n = 1230; RR 1.81, 95% CI 1.65 to 1.98), satisfaction with intrapartum care (one trial; n = 2844; RR 1.14, 95% CI 1.07 to 1.21), and breastfeeding initiation (two trials; n = 1431; RR 1.05, 95% CI 1.02 to 1.09) and continuation to six to eight weeks (two trials; n = 1431; RR 1.06, 95% CI 1.02 to 1.10). Allocation to a home-like setting decreased the likelihood of episiotomy (five trials; n = 8529; RR 0.85, 95% CI 0.74 to 0.99). There was a trend towards higher perinatal mortality in the home-like setting (five trials; n = 8529; RR 1.83, 95% CI 0.99 to 3.38). No firm conclusions could be drawn regarding the effects of staffing or organizational models.

ConclusionsWhen compared to conventional institutional settings, home-like settings for childbirth are associated with modest benefits, including reduced medical interventions and increased maternal satisfaction. Caregivers and clients should be vigilant for signs of complications.

5) Patterns of routine antenatal care for low-risk pregnancyJosé Villar, Guillermo Carroli, Dina Khan-Neelofu, Gilda GP Piaggio, A Metin Gülmezoglu

Objectives

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The objective of this review was to assess the effects of antenatal care programmes for low-risk women.

Selection criteriaRandomised trials comparing programmes of antenatal care with varied frequency and timing of the visits and different types of care providers.

Data collection and analysisTrial quality was assessed and data were extracted by two reviewers independently. Study authors were contacted for additional information and they were provided with the final version of the review.

Main resultsTen trials involving over 60,000 women were included. Seven trials evaluated the number of antenatal clinic visits, and three trials evaluated the type of care provider. Most trials were of acceptable quality. A reduction in the number of antenatal visits was not associated with an increase in any of the negative maternal and perinatal outcomes reviewed. However, trials from developed countries suggest that women can be less satisfied with the reduced number of visits and feel that their expectations with care are not fulfilled. Antenatal care provided by a midwife/general practitioner was associated with improved perception of care by women. Clinical effectiveness of midwife/general practitioner managed care was similar to that of obstetrician/gynaecologist led shared care.

Authors' conclusionsA reduction in the number of antenatal care visits with or without an increased emphasis on the content of the visits could be implemented without any increase in adverse biological maternal and perinatal outcomes. Women can be less satisfied with reduced visits. Lower costs for the mothers and providers could be achieved. While clinical effectiveness seemed similar, women appeared to be slightly more satisfied with midwife/general practitioner managed care compared with obstetrician/gynaecologist led shared care.

6) Biophysical profile for fetal assessment in high risk pregnanciesJoan G Lalor, Bukola Fawole, Zarko Alfirevic, Declan Devane

ObjectivesTo assess the effects of the BPP when compared with conventional monitoring (CTG only or MBPP) on pregnancy outcome in high-risk pregnancies.

Selection criteriaRandomised and quasi-randomised controlled trials involving a comparison of fetal BPP with other forms of antepartum fetal assessment in women with high-risk pregnancies.

Data collection and analysisTwo authors independently assessed eligibility, quality and extracted data.

Main resultsWe included five trials, involving 2974 women. Most trials were not of high quality. Although the overall incidence of adverse outcomes was low, available evidence from randomised

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controlled trials does not support the use of BPP as a test of fetal wellbeing in high-risk pregnancies. We found no significant differences between the groups in perinatal deaths (relative risk (RR) 1.33, 95% confidence interval (CI) 0.60 to 2.98) or in Apgar score less than seven at five minutes (RR 1.27, 95% CI 0.85 to 1.92).Combined data from the two high-quality trials suggest an increased risk of caesarean section in the BPP group RR 1.60, 95% CI 1.05 to 2.44, n = 280, interaction test P = 0.03. However, the number of participating women was relatively small (n = 280). Therefore, additional evidence is required in order to be definitive regarding the efficacy of this test in high-risk pregnancies. Furthermore, the impact of the BPP on other interventions, length of hospitalisation, serious short-term and long-term neonatal morbidity and parental satisfaction requires further evaluation.

Authors' conclusionsAt present, there is insufficient evidence from randomised trials to support the use of BPP as a test of fetal wellbeing in high-risk pregnancies.

7) Castor oil, bath and/or enema for cervical priming and induction of labourAnthony J Kelly, Josephine Kavanagh, Jane Thomas

Selection criteriaClinical trials comparing castor oil, bath or enemas used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.

Data collection and analysisA strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction.

Main resultsIn the one included study of 100 women, which compared a single dose of castor oil versus no treatment, no evidence of a difference was found between caesarean section rates (relative risk (RR) 2.31, 95% confidence interval (CI) 0.77, 6.87). No data were presented on neonatal or maternal mortality or morbidity. There was no evidence of a difference between either the rate of meconium stained liquor (RR 0.77, 95% CI 0.25 to 2.36) or Apgar score less than seven at five minutes (RR 0.92, 95% CI 0.02 to 45.71) between the two groups. The number of participants was small hence only large differences in outcomes could have been detected. All women who ingested castor oil felt nauseous (RR 97.08, 95% CI 6.16 to 1530.41).

Authors' conclusionsThe only trial included in this review attempts to address the role of castor oil as an induction agent. The trial was small and of poor methodological quality. Further research is needed to attempt to quantify the efficacy of castor oil as an induction agent.

8) Homoeopathy for induction of labourCaroline A Smith

Objectives

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To determine the effects of homoeopathy for third trimester cervical ripening or induction of labour.

Selection criteriaRandomised controlled trials comparing homeopathy used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.

Data collection and analysisA generic strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally.

Main resultsTwo trials, involving 133 women, were included in the review. The trials were placebo controlled and double blind, but the quality was not high. Insufficient information was available on the method of randomisation and the study lacked clinically meaningful outcomes. This trials demonstrated no differences in any primary or secondary outcome between the treatment and control group.

Authors' conclusionsThere is insufficient evidence to recommend the use of homoeopathy as a method of induction. It is likely that the demand for complementary medicine will continue and women will continue to consult a homoeopath during their pregnancy. Although caulophyllum is a commonly used homoeopathic therapy to induce labour, the treatment strategy used in the one trial in which it was evaluated may not reflect routine homoeopathy practice. Rigorous evaluations of individualised homeopathic therapies for induction of labour are needed.

9) Medical versus surgical methods for first trimester termination of pregnancyLale Say, Dalia Brahmi, Regina Kulier, Aldo Campana, A Metin Gülmezoglu

ObjectivesTo evaluate medical methods in comparison to surgical methods for first-trimester abortion with respect to efficacy, side effects and acceptability.

Selection criteriaRandomised trials of any surgical abortion method compared with any medical abortion method in the first trimester.

Data collection and analysisTrial quality was assessed and data extraction was made independently by two reviewers.

Main resultsSeven studies mostly with small sample sizes, comparing 4 different interventions (prostaglandins alone, mifepristone alone, and mifepristone/misoprostol and

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methotrexate/misoprostol versus vacuum aspiration) were included. Results are sometimes based on one trial only. Prostaglandins vs vacuum aspiration: the rate of abortions not completed with the intended method was statistically significant higher in the prostaglandin group (2.7, 95% CI 1.1 to 6.8) compared to surgery. There are no data on the most commonly medical (mifepristone/misoprostol) and surgical abortion available to be included in the review. Duration of bleeding was longer in the medical abortion groups compared to vacuum aspiration. There was only one major complication (uterine perforation) in one trial in the surgical group. There was no difference between the groups for ongoing pregnancies at the time of follow-up or pelvic infections. No data on acceptability, side effects or women's satisfaction with the procedure were availbale for inclusion in the review.

Authors' conclusionsThe results are derived from relatively small trials. Prostaglandins used alone seems to be less effective and more painful compared to surgical first-trimester abortion. However, there is inadequate evidence to comment on the acceptability and side effects of medical compared to surgical first-trimester abortions. There is a need for trials to address the efficacy of currently used methods and women's preferences more reliably.

10) Progestogen for treating threatened miscarriageHayfaa A Wahabi, Nuha F Abed Althagafi ,Mamoun Elawad, Rasmieh A Al Zeidan

ObjectivesTo determine the efficacy and the safety of progestogens in the treatment of threatened miscarriage.

Search strategyWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2009) and bibliographies of all located articles for any unidentified articles.

Data collection and analysisAt least two authors assessed the trials for inclusion in the review and extracted the data.

Main resultsTwo studies (84 participants) were included in the meta-analysis. In one study, all the participants met the inclusion criteria and in the other study, only the subgroup of participants who met the inclusion criteria was included in the meta-analysis. There was no evidence of effectiveness with the use vaginal progesterone compared to placebo in reducing the risk of miscarriage (risk ratio 0.47; 95% confidence interval 0.17 to 1.30).

Authors' conclusionsBased on scarce data from two methodologically poor trials, there is no evidence to support the routine use of progestogens for the treatment of threatened miscarriage. Information about potential harms to the mother or child, or both, with the use of progestogens is lacking. Further, larger, randomized controlled trials on the effect of progestogens on the treatment of threatened miscarriage, which investigate potential harms as well as benefits, are needed.

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11) Continuous support for women during childbirthEllen D Hodnett, Simon Gates, G Justus Hofmeyr, Carol Sakala

ObjectivesPrimary: to assess the effects, on mothers and their babies, of continuous, one-to-one intrapartum support compared with usual care. Secondary: to determine whether the effects of continuous support are influenced by: (1) routine practices and policies in the birth environment that may affect a woman's autonomy, freedom of movement and ability to cope with labour; (2) whether the caregiver is a member of the staff of the institution; and (3) whether the continuous support begins early or later in labour.

Selection criteriaAll published and unpublished randomized controlled trials comparing continuous support during labour with usual care.

Data collection and analysisWe used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group. All authors participated in evaluation of methodological quality. One author and a research assistant independently extracted the data. We sought additional information from the trial authors. We used relative risk for categorical data and weighted mean difference for continuous data to present the results.

Main resultsSixteen trials involving 13,391 women met inclusion criteria and provided usable outcome data. Primary comparison: women who had continuous intrapartum support were likely to have a slightly shorter labour, were more likely to have a spontaneous vaginal birth and less likely to have intrapartum analgesia or to report dissatisfaction with their childbirth experiences. Subgroup analyses: in general, continuous intrapartum support was associated with greater benefits when the provider was not a member of the hospital staff, when it began early in labour and in settings in which epidural analgesia was not routinely available.

Authors' conclusionsAll women should have support throughout labour and birth.

12)Topical treatment for vaginal candidiasis (thrush) in pregnancyGavin Young, David Jewell

ObjectivesThe objective of this review was to assess the effects of different methods of treating vaginal candidiasis in pregnancy.

Selection criteriaRandomised trials of any treatment for vaginal candidiasis in pregnancy.

Data collection and analysis

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Two reviewers assessed trial quality and extracted data.

Main resultsTen trials were included. Based on five trials, imidazole drugs were more effective than nystatin when treating vaginal candidiasis in pregnancy (odds ratio 0.21, 95% confidence interval 0.16 to 0.29). In turn, Nystatin was as effective as hydrargaphen in one trial (odds ratio 0.29, 95% confidence interval 0.05-1.84). A trial of clotrimazole was more effective than placebo (odds ratio 0.14, 95% confidence interval 0.06 to 0.31). Single dose treatment was no more or less effective than three or four days treatment. However, two trials involving 81 women, showed that treatment lasting for four days was less effective than treatment for seven days (odds ratio 11.7, 95% confidence interval 4.21 to 29.15). Based on two trials, treatment for seven days was no more or less effective than treatment for 14 days (odds ratio 0.41, 95% confidence interval 0.16 to 1.05). Terconazole was as effective as clotrimazole (odds ratio 1.41, 95% confidence interval 0.28- 7.10).

Authors' conclusionsTopical imidazole appears to be more effective than nystatin for treating symptomatic vaginal candidiasis in pregnancy. Treatments for seven days may be necessary in pregnancy rather than the shorter courses more commonly used in non-pregnant women.

13) Symphysis-fundal height measurement in pregnancyJames P Neilso

ObjectivesThe objective of this review was to assess the effects of routine use of symphysis-fundal height measurements (tape measurement of the distance from the pubic symphysis to the uterine fundus) during antenatal care on pregnancy outcome.

Selection criteriaAcceptably controlled trials comparing symphysis-fundal height measurement with assessment by abdominal palpation alone.

Data collection and analysisOne reviewer assessed trial quality and extracted data.

Main resultsOne trial involving 1639 women was included. No obvious differences were detected in any of the outcomes measured.

Authors' conclusionsThere is not enough evidence to evaluate the use of symphysis-fundal height measurements during antenatal care

14) Interventions for suspected placenta praeviaJames P Neilson

ObjectivesTo assess the impact of any clinical intervention applied specifically because of a perceived likelihood that a pregnant woman might have placenta praevia.

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Selection criteriaAny controlled clinical trial that has assessed the impact of an intervention in women diagnosed as having, or being likely to have, placenta praevia.

Data collection and analysisData were extracted, unblinded, by the author without consideration of results.

Main resultsThree trials were included, involving a total of 114 women. Both tested interventions (home versus hospitalisation and cervical cerclage versus no cerclage) were associated with reduced lengths of stay in hospital antenatally: weighted mean difference (WMD) respectively -18.50 days (95% confidence interval (CI) -26.83 to -10.17), -4.80 days (95% CI -6.37 to -3.23). Otherwise, there was little evidence of any clear advantage or disadvantage to a policy of home versus hospital care. The one woman who had a haemorrhage severe enough to require immediate transfusion and delivery was in the home care group. Cervical cerclage may reduce the risk of delivery before 34 weeks: relative risk (RR) 0.45 (95% CI 0.23 to 0.87), or the birth of a baby weighing less than two kilograms RR 0.34 (0.14 to 0.83) or having a low five minute Apgar score RR 0.19 (0.04 to 1.00). In general, these possible benefits were more evident in the trial of lower methodological quality.

Authors' conclusionsThere are insufficient data from trials to recommend any change in clinical practice. Available data should, however, encourage further work to address the safety of more conservative policies of hospitalisation for women with suspected placenta praevia, and the possible value of insertion of a cervical suture.

15)Treatments for suppression of lactationOlufemi T Oladapo, Bukola Fawole

ObjectivesTo evaluate the effectiveness and safety of interventions used for suppression of lactation in postpartum women (who have not breastfed or expressed breastmilk) to determine which approach has the greatest comparative benefits with least risk

Data collection and analysisTwo authors independently assessed trial quality and extracted data.

Main resultsWe included 46 trials (5164 women). The trials were generally small and of limited quality. Five trials (206 women) indicated that bromocriptine significantly reduced the proportion of women lactating compared to no treatment at or within seven days postpartum (three trials, 107 women; relative risk (RR) 0.36, 95% confidence interval (CI) 0.24 to 0.54). Six trials involving oestrogen preparations (diethylstilbestrol, quinestrol, chlorotrianisene, hexestrol) suggested that they significantly reduced the proportion of lactating women compared to no treatment at or within seven days postpartum (RR 0.41, 95% CI 0.29 to 0.59). We found no trials comparing nonpharmacologic methods with no treatment. Trials comparing bromocriptine with other pharmacologic agents suggested similarity in their effectiveness (RR 0.79, 95% CI 0.54 to 1.17).

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Side effects were poorly reported in the trials and no case of thromboembolism was recorded in the four trials that reported it as an outcome.

Authors' conclusionsThere is weak evidence that some pharmacologic treatments (most of which are currently unavailable to the public) are better than no treatment for suppressing lactation symptoms in the first postpartum week. No evidence currently exists to indicate whether nonpharmacologic approaches are more effective than no treatment. Presently, there is insufficient evidence to address the side effects of methods employed for suppressing lactation. When women desire treatment, bromocriptine may be considered where it is registered for lactation suppression in those without predisposition to its major side effects of public concerns. Large randomised trials are needed to compare the effectiveness of pharmacologic (especially bromocriptine) and nonpharmacologic methods to no treatment. Such trials should consider acceptability of the intervention and lactation symptoms of concern to women and be large enough to detect clinically important differences in major side effects between comparison groups.

16) Music during caesarean section under regional anaesthesia for improving maternal and infant outcomesMalinee Laopaiboon, Pisake Lumbiganon, Ruth Martis, Patravoot Vatanasapt, Busaba Somjaivong

ObjectivesTo evaluate the effectiveness of music during caesarean section under regional anaesthesia for improving clinical and psychological outcomes for mothers and infants.

Selection criteriaWe included randomised controlled trials comparing music added to standard care during caesarean section under regional anaesthesia to standard care alone.

Data collection and analysisTwo review authors, Malinee Laopaiboon and Ruth Martis, independently assessed eligibility, risk of bias in included trials and extracted data. We analysed continuous outcomes using a mean difference (MD) with a 95% confidence interval (CI).

Main resultsOne trial involving 76 women who planned to have their babies delivered by caesarean section met the inclusion criteria, but data were available for only 64 women. This trial was of low quality with unclear allocation concealment and only a few main clinical outcomes reported for the women. The trial did not report any infant outcomes. It appears that music added to standard care during caesarean section under regional anaesthesia had some impact on pulse rate at the end of maternal contact with the neonate in the intra-operative period (MD -7.50 fewer beats per minute, 95% CI -14.08 to -0.92) and after completion of skin suture for the caesarean section (MD -7.37 fewer beats per minute, 95% CI -13.37 to -1.37). There was also an improvement in the birth satisfaction score (maximum possible score of 35) (MD of 3.38, 95%CI 1.59 to 5.17). Effects on other outcomes were either not significant or not reported in the one included trial.

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Authors' conclusionsThe findings indicate that music during planned caesarean section under regional anaesthesia may improve pulse rate and birth satisfaction score. However, the magnitude of these benefits is small and the methodological quality of the one included trial is questionable. Therefore, the clinical significance of music is unclear. More research is needed to investigate the effects of music during caesarean section under regional anaesthesia on both maternal and infant outcomes, in various ethnic pregnant women, and with adequate sample sizes.

17) Anti-D administration in pregnancy for preventing Rhesus alloimmunisationCaroline A Crowther, Philippa Middleton

ObjectivesTo assess the effects of antenatal anti-D immunoglobulin on the incidence of Rhesus D alloimmunisation when given to Rh-negative women without anti-D antibodies.

Selection criteriaRandomised trials in Rh-negative women without anti-D antibodies given anti-D after 28 weeks of pregnancy, compared with no treatment or placebo.

Data collection and analysisOne review author extracted and double-entered data; these were checked by another review author.

Main resultsTwo average to poor-quality trials, involving over 4500 women, compared anti-D prophylaxis with no treatment. When women received anti-D at 28 and 34 weeks' gestation, relative risk (RR) of immunisation during pregnancy was 0.42 (95% confidence interval (CI) 0.15 to 1.17); after the birth of a Rh-positive infant the RR was 0.42 (95% CI 0.15 to 1.17); and within 12 months after birth of a Rh-positive infant the RR was 0.41 (95% CI 0.16 to 1.04). While none of these differences were statistically significant, the risk difference (RD) between anti-D and no treatment was significant (RD -0.01, 95% CI -0.01 to 0.00) suggesting reduced incidence of immunisation after anti-D prophylaxis.

In the higher dose trial (100 µg; 500 international units (IU) anti-D), there was a nonsignificant reduction in immunisation at two to 12 months following birth of a Rh-positive infant in women who had received anti-D (RR 0.14, 95% CI 0.02 to 1.15). However, women receiving anti-D were significantly less likely to register a positive Kleihauer test (which detects fetal cells in maternal blood) in pregnancy (RR 0.60, 95% CI 0.41 to 0.88) and at the birth of a Rh-positive infant (RR 0.60, 95% CI 0.46 to 0.79). No data were available for the risk of Rhesus D alloimmunisation in a subsequent pregnancy. No differences were seen for neonatal jaundice.

Authors' conclusionsThe risk of Rhesus D alloimmunisation during or immediately after a first pregnancy is about 1%. Administration of 100 µg (500 IU) anti-D to women in their first pregnancy can reduce this risk to about 0.2% without, to date, any adverse effects. Although unlikely to confer benefit in

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the current pregnancy, fewer women may have Rhesus D antibodies in any subsequent pregnancy, but the effects of this needs to be tested in studies of robust design.

18 ) Fundal pressure versus controlled cord traction as part of the active management of the third stage of labourGuiomar E Peña-Martí, Gabriella Comunián-Carrasco

.ObjectivesTo determine the efficacy of fundal pressure versus controlled cord traction as part of the active management of the third stage of labour.

Selection criteriaWe searched for published and unpublished randomised and quasi-randomised controlled trials.

Data collection and analysisTwo review authors independently identified potential studies from the literature search and assessed them for methodological quality and appropriateness of inclusion.

Main resultsThe search strategies yielded five studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review.

Authors' conclusionsWe identified no randomised controlled trials comparing the efficacy of fundal pressure versus controlled cord traction as part of the active management of the third stage of labour. Hence controlled cord traction, after awaiting signs of placental separation, should remain the third component of the active management of third stage of labour, and follow the routine administration of a uterotonic drug and cord clamping.

19) Prostaglandins for preventing postpartum haemorrhageA Metin Gülmezoglu, Fatu Forna, José Villar, G Justus Hofmeyr

ObjectivesTo assess the effects of prophylactic prostaglandin use in the third stage of labour.

Selection criteriaRandomized trials comparing a prostaglandin agent with another uterotonic or no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of labour. The primary outcomes were blood loss 1000 ml or more and the use of additional uterotonics.

Data collection and analysisTwo review authors independently assessed eligibility and trial quality and extracted data.

Main resultsThirty-seven misoprostol and nine intramuscular prostaglandin trials (42,621 women) were included. Oral (seven trials, 2849 women) or sublingual misoprostol (relative risk (RR) 0.66; 95% confidence interval (CI) 0.45 to 0.98; one trial, 661 women) compared to placebo may be

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effective in reducing severe PPH and blood transfusion (RR 0.31; 95% CI 0.10 to 0.94; five oral misoprostol trials, 3519 women). The severe PPH analysis of oral misoprostol trials was not totalled due to significant heterogeneity.

Compared to conventional injectable uterotonics, oral misoprostol was associated with higher risk of severe PPH (RR 1.32; 95% CI 1.16 to 1.51; 16 trials, 29,042 women) and use of additional uterotonics but with fewer blood transfusions (RR 0.81; 95% CI 0.64 to 1.02; 15 trials, 27,858 women). Additional uterotonic data were not totalled due to heterogeneity. Misoprostol use is associated with significant increases in shivering and a temperature of 38 ºCelsius.

There are scarce data comparing injectable prostaglandins with the conventional injectable uterotonics on severe PPH and the use of additional uterotonics, the primary outcomes of this review.

Authors' conclusionsMisoprostol orally or sublingually at a dose of 600 mcg shows promising results when compared to placebo in reducing blood loss after delivery. The margin of benefit may be affected by whether other components of management of the third stage of labour are used or not. As side-effects are dose-related, research should be directed towards establishing the lowest effective dose for routine use, and the optimal route of administration.

Neither intramuscular prostaglandins nor misoprostol are preferable to conventional injectable uterotonics as part of the management of the third stage of labour especially for low-risk women.

20) Prophylactic oxytocin for the third stage of labour

Amanda M Cotter, Amen Ness, Jorge E Tolosa

ObjectivesTo examine the effect of oxytocin given prophylactically in the third stage of labour on maternal and neonatal outcomes.

Selection criteriaRandomised or quasi-randomised controlled trials including pregnant women anticipating a vaginal delivery where oxytocin was given prophylactically for the third stage of labour.

Data collection and analysisThe review authors independently assessed trial quality and extracted data. Analysis was by intention to treat. Subgroup analyses were based on extent of selection bias, oxytocin in the context of active or expectant management of the third stage, and timing of administration. Results are presented as relative risks, and weighted mean difference, both with 95% confidence intervals using a fixed-effect model.

Main results

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Fourteen trials are included.In seven trials involving over 3000 women, prophylactic oxytocin showed benefits (reduced blood loss (relative risk (RR) for blood loss greater than 500 ml 0.50; 95% confidence interval (CI) 0.43 to 0.59) and need for therapeutic oxytocics (RR 0.50; 95% CI 0.39 to 0.64) compared to no uterotonics. In six trials involving over 2800 women, there was little evidence of differential effects for oxytocin versus ergot alkaloids, except that oxytocin was associated with fewer manual removals of the placenta (RR 0.57; 95% CI 0.41 to 0.79), and with the suggestion of less raised blood pressure (RR 0.53; 95% CI 0.19 to 1.52) than with ergot alkaloids.In five trials involving over 2800 women, there was little evidence of a synergistic effect of adding oxytocin to ergometrine versus ergometrine alone.

Authors' conclusionsOxytocin appears to be beneficial for the prevention of postpartum haemorrhage. However, there is insufficient information about other outcomes and side-effects hence it is difficult to be confident about the trade-offs for these benefits. There seems little evidence in favour of ergot alkaloids alone compared to either oxytocin alone, or to ergometrine-oxytocin, but the data are sparse. More trials are needed in domiciliary deliveries in developing countries, which shoulder most of the burden of third stage complications.

21) Position in the second stage of labour for women without epidural anaesthesiaJanesh K Gupta, G Justus Hofmeyr, Rebecca MD Smyth

ObjectivesTo assess the benefits and risks of the use of different positions during the second stage of labour (i.e. from full dilatation of the cervix).

Selection criteriaTrials that used randomised or quasi-randomised allocation and appropriate follow up and compared various positions assumed by pregnant women during the second stage of labour.

Data collection and analysisWe independently assessed the trials for inclusion and extracted the data.

Main resultsResults should be interpreted with caution as the methodological quality of the 20 included trials (6135 participants) was variable. Use of any upright or lateral position, compared with supine or lithotomy positions, was associated with: reduced duration of second stage of labour (9 trials: mean 4.28 minutes, 95% confidence interval (CI) 2.93 to 5.63 minutes) - this was largely due to a considerable reduction in women allocated to the use of the birth cushion; a small reduction in assisted deliveries (19 trials: relative risk (RR) 0.80, 95% CI 0.69 to 0.92); a reduction in episiotomies (12 trials: RR 0.83, 95% CI 0.75 to 0.92); an increase in second degree perineal tears (11 trials: RR 1.23, 95% CI 1.09 to 1.39); increased estimated blood loss greater than 500

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ml (11 trials: RR 1.63, 95% CI 1.29 to 2.05); reduced reporting of severe pain during second stage of labour (1 trial: RR 0.73, 95% CI 0.60 to 0.90); fewer abnormal fetal heart rate patterns (1 trial: RR 0.31, 95% CI 0.08 to 0.98).

Authors' conclusionsThe tentative findings of this review suggest several possible benefits for upright posture, with the possibility of increased risk of blood loss greater than 500 ml. Women should be encouraged to give birth in the position they find most comfortable. Until such time as the benefits and risks of various delivery positions are estimated with greater certainty, when methodologically stringent trials' data are available, women should be allowed to make informed choices about the birth positions in which they might wish to assume for delivery of their babies.

22) Placental cord drainage after spontaneous vaginal delivery as part of the management of the third stage of labourHora Soltani, Fiona Dickinson, Ian M Symonds

ObjectivesThe objective of this review was to assess the specific effects of placental cord drainage on the third stage of labour, with or without the prophylactic use of oxytocics.

Selection criteriaRandomised trials involving placental cord drainage as a variable within the package of interventions as part of the management of the third stage of labour.

Data collection and analysisTwo review authors independently assessed the quality of trials and extracted data.

Main resultsTwo studies met our inclusion criteria in terms of quality and relevance. Cord drainage could impact the third stage of labour as the results show a statistically significant reduction in the length of third stage of labour (one trial, n = 147, weighted mean difference (minutes) -5.46, 95% confidence interval (CI) -8.02 to -2.90). In the incidence of retained placenta at 30 minutes after birth (one trial, n = 477, relative risk 0.28, 95% CI 0.10 to 0.73) a significant difference was found, but this should be interpreted with caution due to potential intervention bias.

Authors' conclusionsIt is difficult to draw conclusions from such a small number of studies, especially where the review outcomes were presented in a variety of formats. However, there does appear to be some potential benefit from the use of placental cord drainage in terms of reducing the length of the third stage of labour. More research is required to investigate the impact of cord drainage on the management of the third stage of labour.

23) Antenatal breast examination for promoting breastfeeding

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Sue J Lee, Jane Thomas

ObjectivesTo determine the effect of antenatal breast examination(s) on the initiation of breastfeeding.

Selection criteriaAll randomised controlled trials of the effects of antenatal breast examination, with a concurrent comparison group.

Data collection and analysisTwo review authors independently assessed trial quality and extracted data.

Main resultsWe identified no randomised controlled trials.

Authors' conclusionsIdeally, policies that govern the care of pregnant women should be evidence based. There is no doubt that breastfeeding is beneficial for both mother and infant. However, there is no evidence to support the notion that antenatal breast examinations are effective in promoting breastfeeding, nor any evidence on other potential effects of antenatal breast examination, such as the detection of breast anomalies or satisfaction with care.

24) Interventions for promoting the initiation of breastfeedingLisa Dyson, Felicia M McCormick, Mary J Renfrew

ObjectivesTo evaluate the effectiveness of interventions which aim to encourage women to breastfeed in terms of changes in the number of women who start to breastfeed.

Selection criteriaRandomised controlled trials, with or without blinding, of any breastfeeding promotion intervention in any population group except women and infants with a specific health problem.

Data collection and analysisOne review author independently extracted data and assessed trial quality, checked by a second author. We contacted investigators to obtain missing information.

Main resultsEleven trials were included. Statistical analyses were conducted on data from eight trials (1553 women). Five studies (582 women) on low incomes in the USA with typically low breastfeeding rates showed breastfeeding education had a significant effect on increasing initiation rates compared to standard care (risk ratio (RR) 1.57, 95% confidence interval (CI) 1.15 to 2.15, P = 0.005). Subgroup analyses showed that one-to-one, needs-based, informal repeat education sessions and generic, formal antenatal education sessions are effective in terms of an increase in breastfeeding rates among women on low incomes regardless of ethnicity and feeding intention. Needs-based, informal peer support in the antenatal and postnatal periods was also shown to be

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effective in one study conducted among Latina women who were considering breastfeeding in the USA (RR 4.02, 95% CI 2.63 to 6.14, P < 0.00001).

Authors' conclusionsThis review showed that health education and peer support interventions can result in some improvements in the number of women beginning to breastfeed. Findings from these studies suggest that larger increases are likely to result from needs-based, informal repeat education sessions than more generic, formal antenatal sessions. These findings are based only on studies conducted in the USA, among women on low incomes with varied ethnicity and feeding intention, and this raises some questions regarding generalisability to other settings.

25) Methods of milk expression for lactating womenGenevieve E Becker, Felicia M McCormick, Mary J Renfrew

ObjectivesTo assess acceptability, effectiveness, safety, effect on milk composition, bacterial contamination of milk and cost implications of a range of methods of milk expression, including hand expression and manual, battery and electric pumps.

Selection criteriaRandomised and quasi-randomised controlled trials that compared one method or technique of milk expression or pumping with other(s), at any time after birth, and cross-over trials that commenced at least 28 days after birth.

Data collection and analysisTwo authors independently assessed trial quality and extracted data. We sought additional information from the trial authors.

Main resultsTwelve studies met the inclusion criteria of which six (397 mothers) provided data that could be used in the analyses. Compared with hand expression, one study found a significantly greater total volume of milk expressed over six days both with the electrical pump (373.10 ml, 95% confidence interval (CI) 161.09 to 585.11), and with the foot-operated pump (212.10 ml, 95% CI 9.39 to 414.81); however, the difference found between the foot pump and the electric pump was not significant. Mothers provided with a relaxation tape produced a greater volume of milk at one expression than women not provided with the tape (34.70 ml, 95% CI 9.51 to 59.89). Simultaneous pumping took less time than sequential pumping in one study (3.50 hours/week, 95% CI 1.39 to 5.61). No evidence of difference was found in volume with simultaneous or sequential pumping, or for milk contamination, breastfeeding at discharge, fat content of milk, serum prolactin by method of pumping. Maternal satisfaction, adverse effects on mothers and economic effects of interventions were poorly reported.

Authors' conclusionsMothers appear to obtain greater total volumes of milk in six days after birth using the electric or foot powered pump tested compared to hand expression, and a greater volume at one expression during the second week when provided with a relaxation tape. Simultaneous pumping takes less

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time compared to sequential pumping. Further research with larger numbers and more comprehensive reporting is needed, and mothers' reasons for expressing linked to their evaluation of effectiveness rather than market-led research on equipment performance.

26) Interventions for nausea and vomiting in early pregnancyDavid Jewell, Gavin Young

ObjectivesSelection criteriaRandomised trials of any treatment for nausea and/or vomiting in early pregnancy.

Data collection and analysisTwo reviewers assessed the trial quality and extracted the data independently.

Main resultsTwenty-eight trials met the inclusion criteria. For milder degrees of nausea and vomiting, 21 trials were included. These trials were of variable quality. Nausea treatments were: different antihistamine medications, vitamin B6 (pyridoxine), the combination tablet Debendox (Bendectin), P6 acupressure and ginger. For hyperemesis gravidarum, seven trials were identified testing treatments with oral ginger root extract, oral or injected corticosteroids or injected adrenocorticotropic hormone (ACTH), intravenous diazepam and acupuncture. Based on 12 trials, there was an overall reduction in nausea from anti-emetic medication (odds ratio 0.16, 95% confidence interval 0.08 to 0.33).

Authors' conclusionsAnti-emetic medication appears to reduce the frequency of nausea in early pregnancy. There is some evidence of adverse effects, but there is very little information on effects on fetal outcomes from randomised controlled trials. Of newer treatments, pyridoxine (vitamin B6) appears to be more effective in reducing the severity of nausea. The results from trials of P6 acupressure are equivocal. No trials of treatments for hyperemesis gravidarum show any evidence of benefit. Evidence from observational studies suggests no evidence of teratogenicity from any of these treatments.

27) Interventions for heartburn in pregnancyTherese Dowswell, James P Neilson

ObjectivesTo assess the effect of interventions to relieve heartburn in pregnancy.

Selection criteriaWe included randomised controlled trials evaluating interventions to relieve heartburn.

Data collection and analysisWe assessed eligibility for inclusion and extracted data independently.

Main resultsThree studies were eligible for inclusion, together they included a total of 286 women. All three were placebo controlled trials, each examining a different medication to relieve heartburn

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(intramuscular prostigmine, an antacid preparation and an antacid plus ranitidine). All three produced positive findings in favour of the intervention groups. It was not possible to pool findings from studies to produce an overall treatment effect.

Authors' conclusionsThere was little information to draw conclusions on the overall effectiveness of interventions to relieve heartburn in pregnancy.

28) Interventions for preventing and treating pelvic and back pain in pregnancyVictoria Pennick, Gavin Young

ObjectivesTo assess the effects of interventions for preventing and treating back and pelvic pain in pregnancy.

Selection criteriaRandomised controlled trials of any treatment to prevent or reduce the incidence or severity of back or pelvic pain in pregnancy.

Data collection and analysisTwo authors independently assessed trial quality and extracted data.

Main resultsWe found no studies dealing specifically with prevention of back or pelvic pain. We included eight studies (1305 participants) that examined the effects of adding various pregnancy-specific exercises, physiotherapy, acupuncture and pillows to usual prenatal care.

For women with low-back pain, participating in strengthening exercises, sitting pelvic tilt exercises (standardised mean difference (SMD) -5.34; 95% confidence interval (CI) -6.40 to -4.27), and water gymnastics reduced pain intensity and back pain-related sick leave (relative risk (RR) 0.40; 95% CI 0.17 to 0.92) better than usual prenatal care alone.

The specially-designed Ozzlo pillow was more effective than a regular one in relieving back pain (RR 1.84; 95% CI 1.32 to 2.55), but is no longer commercially available. Both acupuncture and stabilising exercises relieved pelvic pain more than usual prenatal care. Acupuncture gave more relief from evening pain than exercises. For women with both pelvic and back pain, in one study, acupuncture was more effective than physiotherapy in reducing the intensity of their pain; stretching exercises resulted in more total pain relief (60%) than usual care (11%); and 60% of those who received acupuncture reported less intense pain, compared to 14% of those receiving usual prenatal care. Women who received usual prenatal care reported more use of analgesics, physical modalities and sacroiliac belts.

Authors' conclusionsAll but one study had moderate to high potential for bias, so results must be viewed cautiously. Adding pregnancy-specific exercises, physiotherapy or acupuncture to usual prenatal care appears to relieve back or pelvic pain more than usual prenatal care alone, although the effects

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are small. We do not know if they actually prevent pain from starting in the first place. Water gymnastics appear to help women stay at work. Acupuncture shows better results compared to physiotherapy.

29) Interventions for treating constipation in pregnancyDavid Jewell, Gavin Young

ObjectivesThe objective of this review was to assess the effects of different methods for treating constipation in pregnancy.

Selection criteriaRandomised trials of any treatment for constipation in pregnancy.

Data collection and analysisTrial quality assessments and data extraction were done independently by two reviewers.

Main resultsTwo suitable trials were identified. Fibre supplements increased the frequency of defecation (odds ratio 0.18, 95% confidence interval 0.05 to 0.67), and lead to softer stools. Stimulant laxatives are more effective than bulk-forming laxatives (odds ratio 0.30, 95% confidence interval 0.14 to 0.61), but may cause more side effects.

Authors' conclusionsDietary supplements of fibre in the form of bran or wheat fibre are likely to help women experiencing constipation in pregnancy. If the problem fails to resolve, stimulant laxatives are likely to prove more effective.

EVIDENCE BASED PRACTICES IN NEONATALogy

1) Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomesSusan J McDonald, Philippa Middleton

ObjectivesTo determine the effects of different policies of timing of cord clamping at delivery of the placenta on maternal and neonatal outcomes.

Selection criteriaRandomised controlled trials comparing early and late cord clamping.

Data collection and analysisTwo review authors independently assessed trial eligibility and quality and extracted data.

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Main resultsWe included 11 trials of 2989 mothers and their babies. No significant differences between early and late cord clamping were seen for postpartum haemorrhage or severe postpartum haemorrhage in any of the five trials (2236 women) which measured this outcome (relative risk (RR) for postpartum haemorrhage 500 mls or more 1.22, 95% confidence interval (CI) 0.96 to 1.55). For neonatal outcomes, our review showed both benefits and harms for late cord clamping. Following birth, there was a significant increase in infants needing phototherapy for jaundice (RR 0.59, 95% CI 0.38 to 0.92; five trials of 1762 infants) in the late compared with early clamping group. This was accompanied by significant increases in newborn haemoglobin levels in the late cord clamping group compared with early cord clamping (weighted mean difference 2.17 g/dL; 95% CI 0.28 to 4.06; three trials of 671 infants), although this effect did not persist past six months. Infant ferritin levels remained higher in the late clamping group than the early clamping group at six months.

Authors' conclusionsOne definition of active management includes directions to administer an uterotonic with birth of the anterior shoulder of the baby and to clamp the umbilical cord within 30-60 seconds of birth of the baby (which is not always feasible in practice). In this review delaying clamping of the cord for at least two to three minutes seems not to increase the risk of postpartum haemorrhage. In addition, late cord clamping can be advantageous for the infant by improving iron status which may be of clinical value particularly in infants where access to good nutrition is poor, although delaying clamping increases the risk of jaundice requiring phototherapy.

2) Prophylactic animal derived surfactant extract for preventing morbidity and mortality in preterm infantsRoger Soll,Eren Özek

ObjectivesTo assess the effect of prophylactic intratracheal administration of animal derived surfactant extract on mortality, bronchopulmonary dysplasia (BPD) and other morbidities in preterm newborns at risk for developing RDS. Subgroup analysis were planned according to the specific surfactant product and the degree of prematurity.

Selection criteriaRandomized or quasi-randomized controlled trials that compared the effect of prophylactic animal derived surfactant extract administration (surfactant obtained from human, porcine or bovine sources, either modified with additional phospholipids or not) administered to high risk preterm newborns at or shortly after birth in order to prevent RDS, mortality and other complications of prematurity.

Data collection and analysisData extraction and analysis was done in accordance with the standards of the CNRG.

Main results

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All nine of the included studies note an initial improvement in respiratory status and a decrease in the risk of RDS in infants who receive prophylactic animal derived surfactant extract. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.40, 95% CI 0.29, 0.54; typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease in the risk pulmonary interstitial emphysema (PIE) (typical relative risk 0.46, 95% CI 0.36, 0.59; typical risk difference -0.16, 95% CI -0.21, -0.11), a decrease in the risk of neonatal mortality (typical relative risk 0.60, 95% CI 0.47, 0.77; typical risk difference -0.07, 95% CI -0.12, -0.03), and a decrease in the risk of BPD or death (typical relative risk 0.80, 95% CI 0.72, 0.88; typical risk difference -0.10, 95% CI -0.16, -0.04). No differences are reported in the risk of intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis or retinopathy of prematurity. Few data are available on long-term follow-up of treated infants.

Authors' conclusionsProphylactic intratracheal administration of animal derived surfactant extract to infants judged to be at risk of developing respiratory distress syndrome has been demonstrated to improve clinical outcome. Infants who receive prophylactic animal derived surfactant extract have a decreased risk of pneumothorax, a decreased risk of PIE, a decreased risk of mortality, and a decreased risk of BPD or death.

3)Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 gramsShahirose S Premji, Lorraine Chessell

ObjectivesTo examine the evidence regarding the effectiveness of continuous vs. intermittent bolus nasogastric milk feeding in premature infants less than 1500 grams.

Selection criteriaRandomized and quasi-randomized clinical trials comparing continuous vs. intermittent bolus nasogastric milk feeding in premature infants less than 1500 grams.

Data collection and analysisTwo review authors independently assessed all trials for relevance and methodologic quality. The standard methods of the Cochrane Neonatal Review Group were used to extract data.

Main resultsOverall, the seven included trials, involving 511 infants, found no differences in time to achieve full enteral feeds between feeding methods (weighted mean difference (WMD) 2 days; 95% CI -0.3, 3.9) . In the subgroup analysis of those studies comparing continuous nasogastric vs. intermittent bolus nasogastric milk feedings the findings remained unchanged (WMD 2 days, 95% CI -0.4, 4.1). There was no significant difference in somatic growth and incidence of NEC between feeding methods irrespective of tube placement. One study noted a trend toward more

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apneas during the study period in infants fed by the continuous tube feeding method compared to those fed by intermittent feedings delivered predominantly by orogastric tube placements [mean difference (MD) 14.0 apneas during study period; 95% CI -0.2, 28.2]. In subgroup analysis based on weight groups, one study suggested that infants less than 1000 grams and 1000 - 1250 grams birth weight gained weight faster when fed by the continuous nasogastric tube feeding method compared to intermittent nasogastric tube feeding method (MD 2.0 g/day; 95% CI 0.5, 3.5; MD 2.0 g/day; 95% CI 0.2, 3.8, respectively). A trend toward earlier discharge for infants less than 1000 grams birth weight fed by the continuous tube feeding method compared to intermittent nasogastric tube feeding method (MD -11 days; 95% CI -21.8, -0.2).

Authors' conclusionsSmall sample sizes, methodologic limitations, inconsistencies in controlling variables that may affect outcomes, and conflicting results of the studies to date make it difficult to make universal recommendations regarding the best tube feeding method for premature infants less than 1500 grams. The clinical benefits and risks of continuous vs. intermittent nasogastric tube milk feeding cannot be reliably discerned from the limited information available from randomized trials to date.

4) Nasal versus oral route for placing feeding tubes in preterm or low birth weight infantsJudith Hawes, Peter McEwan, William McGuire

ObjectivesTo determine the effect of nasal compared with oral placement of enteral feeding tubes on feeding, growth and development, and the incidence of adverse consequences in preterm or low birth weight infants.

Selection criteriaRandomised or quasi-randomised controlled trials that compared the use of the nasal versus oral route for placing enteral feeding tubes in preterm or low birth weight infants.

Data collection and analysisThe standard methods of the Cochrane Neonatal Review Group were used, with separate evaluation of trial quality and data extraction by two authors. Data synthesis using a fixed effects model and reporting typical relative risk, typical risk difference and weighted mean difference was planned.

Main resultsTwo small randomised trials were identified. Only one trial reported data on the pre-specified primary outcomes for this review. This trial found no evidence of effect on the time taken to establish enteral feeding nor the time taken to regain birth weight. However, the trial was underpowered (N= 46) to exclude modest effect sizes.

Authors' conclusionsThere are insufficient data available to inform practice. A large randomised controlled trial is required to determine if the use of naso- vs. oro-enteric feeding tubes affects feeding, growth and development, and the incidence of adverse consequences in preterm or low birth weight infants.

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4)Cot-nursing versus incubator care for preterm infantsPeter H Gray, Vicki Flenady

ObjectivesAmong preterm infants allocated to cot-nursing vs incubator care in neonatal period, to assess effects on their temperature control and weight gain.

Selection criteria

All trials using random or quasi-random patient allocation in which infants receiving care in standard newborn cots were compared to infants managed in a conventional air heated incubator.

Data collection and analysisThe authors independently assessed trial quality and extracted data for the primary outcomes of temperature control and weight gain. Meta-analysis was conducted using a fixed effects model. Results are presented as relative risk (RR) for categorical data and mean difference (MD) and weighted mean differences (WMD) for data measured on a continuous scale.

Main resultsNine potential studies were identified of which four, involving 173 babies, were included in this review. When compared to incubator care, cot-nursing resulted in a statistically significantly higher mean body temperature (MD 0.30 degrees C; 95% CI 0.10, 0.50, one trial) and a decrease in proportion of infants not breast feeding at hospital discharge (RR 0.52; 95% CI 0.28, 0.94, two trials, 77 infants). No statistically significant difference was shown in weight gain, reported by two trials involving 69 infants. The comparison of cot-nursing using a heated water-filled mattress versus incubator care, which included four trials and a total of 149 infants, produced similar results. Cot-nursing with warming of the nursery resulted in statistically significantly smaller weight gain during week one compared to the incubator group in one trial that involved 49 infants (MD -5.90 g/kg/day; 95% CI -11.13, -0.67) with no significant difference found for weeks two and three.

Authors' conclusionsDue to the small numbers of trials included and infants studied, and the resulting imprecision in the measures of effect for all outcomes, the review does not give a clear indication for the role of cot-nursing for preterm infants. Further assessment of the role of cot nursing for preterm infants using randomised controlled trials is necessary.

5) Kangaroo mother care to reduce morbidity and mortality in low birthweight infantsAgustin Conde-Agudelo, José M Belizán

ObjectivesTo determine whether there is evidence to support the use of KMC in LBW infants as an alternative to conventional care after the initial period of stabilization with conventional care.

Selection criteriaRandomized trials comparing KMC and conventional neonatal care in LBW infants.

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Data collection and analysisTrial quality was assessed and data were extracted independently by two reviewers. Statistical analysis was conducted using the standard Cochrane Collaboration methods.

Main resultsThree studies, involving 1362 infants, were included. All the trials were conducted in developing countries. The studies were of moderate to poor methodological quality. The most common shortcomings were in the areas of blinding procedures for those who collected the outcomes measures, handling of drop outs, and completeness of follow-up. The great majority of results consist of results of a single trial. KMC was associated with the following reduced risks: nosocomial infection at 41 weeks' corrected gestational age (relative risk 0.49, 95% confidence interval 0.25 to 0.93), severe illness (relative risk 0.30, 95% confidence interval 0.14 to 0.67), lower respiratory tract disease at 6 months follow-up (relative risk 0.37, 95% confidence interval 0.15 to 0.89), not exclusively breastfeeding at discharge (relative risk 0.41, 95% confidence interval 0.25 to 0.68), and maternal dissatisfaction with method of care (relative risk 0.41, 95% confidence interval 0.22 to 0.75). KMC infants had gained more weight per day by discharge (weighted mean difference 3.6 g/day, 95% confidence interval 0.8 to 6.4). Scores on mother's sense of competence according to infant stay in hospital and admission to NICU were better in KMC than in control group (weighted mean differences 0.31 [95% confidence interval 0.13 to 0.50] and 0.28 [95% confidence interval 0.11 to 0.46], respectively). Scores on mother's perception of social support according to infant stay in NICU were worse in KMC group than in control group (weighted mean difference -0.18 (95% confidence interval -0.35 to -0.01). Psychomotor development at 12 months' corrected age was similar in the two groups. There was no evidence of a difference in infant mortality. However, serious concerns about the methodological quality of the included trials weaken credibility in these findings.

Authors' conclusionsAlthough KMC appears to reduce severe infant morbidity without any serious deleterious effect reported, there is still insufficient evidence to recommend its routine use in LBW infants. Well designed randomized controlled trials of this intervention are needed.

6) Radiant warmers versus incubators for regulating body temperature in newborn infantsVicki Flenady, Paul G Woodgate

ObjectivesTo assess the effects of radiant warmers versus incubators on neonatal fluid and electrolyte balance, morbidity and mortality.

Selection criteriaRandomised or quasi-randomised trials in which radiant warmers were compared to incubators in a neonatal population.

Data collection and analysis

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Independent data extraction and quality assessment of included trials was conducted by the authors. Data were analysed using relative risk (RR) and weighted mean difference (WMD). Results are presented with 95% confidence intervals. Meta-analysis was undertaken using a fixed effect model.

Main resultsEight studies are included in this review; six employed a crossover design. In the overall comparison of radiant warmers vs incubators, radiant warmers caused a statistically significant increase in insensible water loss (IWL) [WMD 0.94g/Kg/day (95% CI 0.47, 1.41)] and a trend towards increased oxygen consumption which was not statistically significant [WMD 0.27mL/kg/min (95% CI -0.09, 0.63)]. Due to small numbers, effects on important clinical outcomes could not be adequately assessed. A comparison of radiant warmers with heat shields vs incubators without heat shields showed a trend for increased IWL in the radiant warmer group, which was not statistically significant. No difference was shown in oxygen consumption.

Authors' conclusionsRadiant warmers result in increased IWL compared to incubators. This needs to be taken into account when calculating daily fluid requirements. The results of this review do not provide sufficient evidence concerning effects on important outcomes to guide clinical practice. Further randomised controlled trials are required to assess the effects of radiant warmers versus incubators in neonatal care on important short and long term outcomes, with particular attention to extremely low birthweight infants in the early neonatal period.

7) Fibreoptic phototherapy for neonatal jaundiceJohn F. Mills, David Tudehope

ObjectivesTo evaluate the efficacy of fibreoptic phototherapy.

Selection criteriaRandomised or quasi-randomised controlled trials evaluating the efficacy of fibreoptic phototherapy in the management of newborn infants with hyperbilirubinaemia.

Data collection and analysisThirty-one studies were identified of which 24 met inclusion criteria. They evaluated the efficacy of fibreoptic phototherapy in a number of different clinical situations and patient populations.

Main resultsFibreoptic phototherapy was more effective at lowering SBR than no treatment but less effective than conventional phototherapy (percentage change in SBR after 24 hours of treatment: WMD -10.7%, 95%CI -18.14, -3.26 and WMD 3.59%, 95%CI 1.27, 5.92 respectively). Fibreoptic phototherapy was equally as effective as conventional phototherapy in preterm infants and when two fibreoptic devices were used simultaneously (change in SBR after 24 hours of treatment: WMD 1.7%, 95%CI -2.65, 6.05 and change in SBR per day over whole treatment period: WMD 2.82%, 95%CI -1.84, 7.48 respectively). A combination of fibreoptic and conventional phototherapy was more effective than conventional phototherapy alone (duration of

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phototherapy: WMD -12.51 hr, 95%CI -16.00, -9.02, meta-analysis affected by heterogeneity). No conclusion can be made on the superiority of one fibreoptic device over another as the two studies comparing them (one favouring BiliBlanket, the other finding no difference) did not contain a common outcome measure.

Authors' conclusionsFibreoptic phototherapy has a place in the management of neonatal hyperbilirubinaemia. It is probably a safe alternative to conventional phototherapy in term infants with physiological jaundice. No trials have been identified which support the widely-held view that fibreoptic devices interfere less with infant care or impact less on parent-child bonding.

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