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Management of Miscarriage: A randomized controlled trial of expectant management versus surgical evacuation of early pregnancy loss

Quek Y.S. (1), Woon S.Y. (1), Ravichandan N. (2), Ravichandran J. (1)

1. Hospital Sultanah Aminah Johor Bahru, Malaysia 2. Singapore General Hospital

Objectives Results Conclusions

References

Approximately 1 in 9 pregnancies end in spontaneous first trimester miscarriage.1 For more than 50 years, the standard management of early pregnancy loss has been dilatation and curettage to prevent risk of gynaecological infection arising from the products of conception. This procedure is considered to be safe, but it carries a small risk of complications related to anesthesia such as anaphylactic shock, cardiotoxicity and hypertensive crisis and of surgical complications such as uterine perforation, intrauterine adhesions, cervical trauma and infection, which has implications on future fertility.2-3

Data is lacking from clinical trials regarding the best management option in women with missed or incomplete miscarriage in terms of risks and complications of both surgical and expectant strategies.

This study is aim to show whether a clinically significant difference exists in success rate between expectant and surgical management of early pregnancy loss.

The data from our study showed that most of the women with incomplete miscarriage whom managed conservatively miscarried within a week from the onset of symptoms. Thus, expectant management was effective for the women with incomplete miscarriage. Their probabilities for spontaneous complete expulsion of products of conception were further decreased after a week. In counselling for management options, women should be informed that success rate is lower with an intact gestational sac and that complete resolution does not usually occur within a week from diagnosis. If the women decided to continue with expectant management, they should be prepared for possibility of surgical intervention.

Results from our study showed that women who were randomized for expectant management with the diagnosis of incomplete miscarriage had higher rate for emergency admission (67%) as well as unplanned surgical intervention (59%) compared to surgical management. Both clinician and patients should be aware of these complications. Careful selection of patients with due to consideration to local availability of facilities for immediate admission and surgical intervention can minimize morbidity.

In our study, most of the women preferred surgical intervention. Their main concern and worry was future fertility issues and infection of their reproductive organs, leading to pelvic inflammatory disease (PID) and compromised fertility. The belief that rapid resolution of early pregnancy loss by performing evacuation of products of conception (ERPOC) was one of the misplaced reasons women preferred surgical intervention rather than expectant management.

Success rate in both groups were comparable. Expectant management is effective for the women with incomplete miscarriage but took slightly longer days for missed miscarriage. Both clinicians and patients should be aware of the possibility of emergency admission and unplanned surgical intervention in cases managed expectantly. However, disadvantages with expectant management include difficulty in obtaining products of conception for confirmation of pregnancy and exclude other pathological condition such as gestational trophoblastic disease or ectopic pregnancy. Management options should be discussed with all the women and effective counselling is associated with good outcome and women will adhere to their preferred that management option without any regrets.

Results

Table 2. Successful of management in study groups

Table 3. Time interval in days for complete miscarriage in the expectant management group after recruitment

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Methods

Randomized controlled trial comparing expectant management with surgical management of early pregnancy loss from January to December 2008 in pregnant women of gestation less than and including 14 weeks with missed or incomplete miscarriages at Hospital Sultanah Aminah, Johor Bahru.

Patients with missed and incomplete miscarriages were counselled regarding the management options namely expectant and surgical intervention. Written consent was obtained from women who agreed to participate in the study and patient information leaflets were given.

Patients were then randomized into two groups. Randomization was effected by computerized analysis.

Results

Total 360 women were recruited and 180 women were randomized to the expectant versus the surgical group. Both groups had similar distribution of demographic data, mean gestational age and the type of miscarriage (Table 1).

There was no statistically significant difference in the success rate between both groups (Table 2). Unplanned ERPOC was higher in expectant management group (61%) compared to surgical intervention (6%).

Table 1. Patient demographics at recruitment

Characteristic Randomized Group P-valueSurgical (n = 180) Expectant (n = 180)

Age 29.11 ± 6.01 28.72 ± 5.58 0.632< 20-year-old 6 (3.3) 8 (4.4)20 to 30-year-old 100 (55.6) 106 (58.9)>30-year-old 74 (41.1) 66 (36.7)

Parity 1.76 ± 1.59 1.79 ± 1.57 0.768Para 0 49 (27.2) 43 (23.9)Para 1-5 128 (71.1) 134 (74.4)> Para 5 3 (1.7) 3 (1.7)

Ethnic Group 0.924Malay 120 (66.7) 118 (65.6)Chinese 28 (15.6) 31 (17.2)Indian 24 (13.3) 25 (13.9)Others 8 (4.4) 6 (3.3)

Gestational age (days ) 73.17 ± 13.80 75.13 ± 13.56 0.221< 56 12 (6.7) 4 (2.2)56 to < 70 44 (24.4) 47 (26.1)70 to < 84 66 (36.7) 65 (36.1)84 to 98 58 (32.2) 64 (35.6)

Symptoms <0.001Bleeding 71 (39.4) 68 (37.8)Pain 37 (20.6) 12 (6.7)Bleeding & Pain 0 (0) 24 (13.3)Passing out POC 72 (40.0) 74 (41.1)Incidental Finding 0 (0) 2 (1.1)

Type of Miscarriage 0.394Missed Miscarriage 108 (60.0) 99 (55.0)Incomplete Miscarriage

72 (40.0) 81 (45.0)

Data expressed in mean ± SD or n (%).

Data expressed as n (%).

Majority of women with incomplete miscarriage miscarried within 7 days and women with intact gestational sac take longer time for spontaneous complete expulsion of products of conception (Table 3). Analysis showed a complication rate of 18.6% in the expectant group, compared to 10.3% in the surgical group (Table 4).

Although there was more bleeding and longer duration of bleeding but there was no significant difference in drop of haemoglobin difference. Both groups have similar outcomes and satisfaction levels (Table 5).

Data expressed as n(%).

Table 4. Complication and management in study group

Data expressed as n (%).

Table 5. Outcome according to treatment allocation

Data expressed in mean ± SD or n (%). *Non-applicable

1. Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ 2000;320:1708-12.

2. C. Demetroulis, E. Saridogan, D. Kunde and A.A. Naftalin, A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. Hum Reprod 16 2 (2001), pp. 365–369.

3. Chung TK, Lee DT, Cheung LP, Haines CJ, Chang AM. Spontaneous abortion: a randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol. Fertil Steril 1999;71:1054-9.

Study Group Successful in study group Total P value

Yes No

Surgical

Missed 83 (80.6) 20 (19.4) 103 (100) 0.197

Incomplete 64 (88.9) 8 (11.1) 72 (100) 0.378

Total 147 (84.0) 28 (16.0) 175 (100)

Expectant

Missed 68 (68.6) 29 (29.3) 99 (100) 0.192

Incomplete 63 (77.7) 17 (21.0) 81 (100) 0.312

Total 131 (74.0) 46 (26.0) 177 (100)

Randomized group P value

Surgical (n = 180)

Expectant (n=180)

Interval days passing out POC in expectant group (Mean days)

Missed Miscarriage NA* 2.68

Incomplete Miscarriage NA* 1.36

Estimate blood loss during ERPOC or passing out POC

122.2 137.0 0.05

Total blood loss 148.19 171.86 0.001

Hemoglobin (gm%) during inclusion of study 12.5 12.4 0.351

Hemoglobin after ERPOC or passing out POC 11.7 11.5 0.333

Difference in Hemoglobin (Hb) level 0.80 0.83 0.641

Duration of bleeding ( Days ) 3.45 5.29 <0.01

Duration of pain ( Days ) 2.39 2.55 0.344

Duration of days return to normal activity 5.10 5.25 0.637

Duration of days resume sexual activity 15.1 17.0 0.013

Satisfaction 7.57 7.57

Complications and Managements Study Group P-valueSurgical(n=175)

Expectant(n=177)

Presence of Complications 28 (16.0%) 33 (18.6%) 0.33Type of Complications

Bleeding & pain requiring admission

9 (5.1%) 25 (14.1%)

Endometritis requiring antibiotic(After ERPOC)

13 (7.4%) 4 (2.3%)

Endometritis requiring antibiotic(No ERPOC)

2 (1.1%) 1 (0.5%)

Septic miscarriage 0 (0%) 3 (1.7%)Retained POC 3 (1.7%) 0 (0%)Uterine perforation 1 (0.6%) 0 (0%)

ManagementEmergency ERPOC 8 (4.8%) 22 (12.4%)Emergency ERPOC and blood transfusion

1 (0.6%) 3 (1.7%)

Antibiotic 15(8.5%) 5 (2.8%)Antibiotic and ERPOC 3 (1.7%) 3 (1.7%)Laparoscopy 1 (0.6%) 0 (0%)

Type of miscarriage

Days Missed Incomplete Total

1 - 3 14 ( 20.5) 48(76.2) 62 (47.3)

4 - 7 29 (42.7) 15 (23.8) 44 (33.7)

8-14 25 (36.8) 0 25 (19)

Total 68 (100) 63 (100) 131*(100)