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Original research article

Clinical outcomes of early postplacental insertion of intrauterinecontraceptive devices

Sevki Celen*, Perran Moroy, Ayhan Sucak, Ayla Aktulay, Nuri Dansman Zekai Tahir Burak Women Health Education and Research Hospital, Ankara, Turkey

Received 9 July 2003; received in revised form 11 November 2003; accepted 3 December 2003

Abstract

Objectives: To assess the efcacy, safety and, thus, advantages and disadvantages, of early postplacental intrauterine device (IUD)insertion.Methods: IUDs were inserted within 10 min after postplacental expulsion in term pregnancy both in vaginal and cesarean deliveries viaa ring forceps. Of the 276 patients enrolled, 235 were included in the study. Recipients were scheduled for examination before hospitaldischarge and at 6 weeks, 6 months and 12 months after postplacental insertion.Results: The percentages of women returning for a follow-up visit were 221 (94%), 210 (89%) and 183 (78%) at 6 weeks, 6 months and12 months, respectively. Among IUD acceptors, 74% of the cases had vaginal deliveries and 26% had cesarean deliveries. Continuation rateswere relatively high, 87.6% and 76.3%, at 6 and 12 months, respectively, after postplacental insertion of IUD. In this study, the 1-yearcumulative expulsion rate with TCu 380A device was 12.3%, which may be regarded as a standard expulsion rate for immediatepostplacental insertion of similar models of IUDs.Conclusion: The evidence from this study suggests that immediate postplacental insertion of CuT 380 models is an effective, useful, safe,convenient and low-cost procedure for early postpartum contraception. 2004 Elsevier Inc. All rights reserved.

Keywords: Intrauterine device; Postplacental insertion

1. Introduction

The concept of early postpartum intrauterine device(IUD) insertion has been investigated since the 1960s andhas become accepted worldwide. For women with limitedaccess to medical care, term delivery provides an importantopportunity to address the need for contraception [1].

Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It providesprotection against pregnancy without interfering withbreastfeeding [2,3]. Moreover, early insertion of an IUD

may avoid discomfort related to insertion. However, in spiteof these advantages, insertion of IUD after delivery is as-sociated with high expulsion rates in several studies [4].

The present study was conducted to assess the efcacyand safety of early postplacental IUD insertion.

2. Materials and methods

This experimental study was carried on healthy volun-teers recruited from the parturients admitted at Zekai TahirBurak women health education and research hospital ma-ternity unit.

Upon admission, the women were informed of the pos-sibility of having an IUD inserted immediately after deliv-ery. Study staff gave information about the study verballyduring the recruitment period. The advantages and disad-vantages of all available methods were explained. All of the

IUD acceptors gave their informed consent.Women who requested an immediate postplacental IUDinsertion, met medical criteria for an IUD insertion and hadno contraindications, were included in the study. IUDs wereinserted within 10 min after postplacental expulsion in aterm pregnancy both in vaginal and cesarean deliveries viaa ring forceps. Cefazolin sodium was used for prophylaxisat cesarean deliveries.

Women were excluded from the study if they had cervi-cal dilatation 6 cm at admission, more than 12 h of

* Corresponding author. Tel.: 00903122406637. E-mail address: [email protected] (Sevki Celen).

Contraception 69 (2004) 279282

0010-7824/04/$ see front matter 2004 Elsevier Inc. All rights reserved.doi:10.1016/j.contraception.2003.12.004


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ruptured membranes, any hemorrhagic disorder, prolongedlabor ( 12 h), history of fever or of clinical symptoms of infection, history of pelvic in ammatory disease or of ec-topic pregnancy. Of the 276 patients enrolled, 235 wereincluded in the study. Clinically obvious pelvic in amma-tory disease (PID) was de ned as the presence of chills,

fever greater than 38 C, lochia with foul odor, associated ornot with spontaneous pain or tenderness of the uterus and/ordelayed uterine involution. It was also diagnosed when thewhite cells ratio showed deviation to the left.

The model TCu 380A postpartum IUD (Pregna; PregnaInternational, Chakan, India) was inserted by one of theauthors after the delivery of placenta via a ring forceps. Atthe time of insertion, the strings of the IUDs were trimmedto extend just beyond the external cervical os. The IUD wasplaced through the hysterotomy incision and then the stringspassed through the cervix, via ring forceps during cesareansection. In the case of cesarean section insertion, the stringswere trimmed immediately after the operation.

Data were collected on sociodemographic characteris-tics, antenatal care, previous contraceptive usage and fam-ily-planning counseling at admission.

Recipients were scheduled for examination before hos-pital discharge and at 6 weeks, 6 months and 12 monthsafter postplacental insertion. At each visit the volunteerswere interviewed by one of the project staff. Physical andpelvic examinations were performed to verify the presenceof the IUD, to check for signs of infection and excessivebleeding. IUD expulsions were veri ed both clinically andsonographically.

The subjects were directed to return at any time if theyexperienced pelvic pain, fever, excessive bleeding or un-usual vaginal discharge. An IUD acceptor was terminatedfrom the study if the IUD was expelled or if a pregnancyoccurred.

Data were validated and entered into a computer. Statis-tical analysis was carried out using SPSS-PC (11.0 version).Life-table analysis was performed to provide cumulativerates. Principal outcome measures include pregnancy andremoval rates, cumulative expulsion and continuation rates.

3. Results

In this study, the loss to follow-up at 12 months afterinsertion was 25%. The number of women returning for afollow-up visit were 221 (94%), 210 (89%) and 183 (78%)at 6 weeks, 6 months and 12 months, respectively.

Demographic characteristics of the study participants areshown in Table 1 . Mean age of the subjects was 24.7 years(range, 19 31 years), 76% of the cases were multiparousand 91% had formal education. Only 26% of the subjectshad used an IUD previously and half of them wanted morechildren. Of 235 subjects, 89 (38%) cases had prenatal careand about half of them received family-planning counselingduring prenatal care.

Among IUD acceptors, 74% of the cases had vaginaldeliveries and 26% had cesarean section deliveries. All of the participants had live births and in only 1% of the caseswere complications at delivery observed.

It should be noted that very low infection and unplannedpregnancy rates were found during the course of this study.Suspected PID occurred in cases 1 and 2, at 6 weeks and 6months postinsertion, respectively. In these cases, the IUDwas removed and antibiotic therapy was administered.There were no other serious complications, such as perfo-rations, associated with immediate postplacental IUD inser-tion. The incidence of minimal complications, such as ir-regular spotting, menorrhagia and uterine cramping, wasnegligible.

Gross cumulative event rates per 100 users are shown inTable 2. Rates of removals for bleeding and/or pain were3.1% in the year after insertion. Terminations for othermedical reasons were minimal ( 2 for per 100 users).Unplanned intrauterine pregnancies were observed in only0.7% of study participants during the course of the study.

Continuation rates were relatively high, 87.6% and76.3% at 6 and 12 months, respectively, after postplacentalinsertion of TCu 380A IUD.

Table 1Clinical characteristics of immediate postplacental IUD insertionacceptors

IUD acceptors(n 235)

Mean age SD (y) 24.7 1.12

Parity1 79 (34)

1 156 (76)Mean no. of living children SD 1.62 0.8Education (any) 213 (91)

Elementary 129 (55)High school 68 (29)University 16 (7)

Previous IUD use 61 (26)Wants more children 99 (42)Mean time until desired pregnancy (y) 3.21 0.5Prenatal care 89 (38)Family-planning counseling during prenatal care 49 (21)

Values in parentheses are percentages.

Table 2Immediate postplacental insertion of CuT 380 model (n 235)

6 Weeks(n 221)

6 Months(n 210)

12 Months(n 183)

Removals forBleeding/pain 0.3 2.8 3.1Other medical reasons 0.1 0.8 1.1Planned pregnancy 0.1 1.1 4.8Personal reasons 0.5 0.8 2.1

Unplanned pregnancy 0.0 0.2 0.3Expulsion rate 5.1 7.0 12.3Continuation rate 94.3 87.6 76.3

Values are gross cumulative event rates per 100 users up to 12 months.

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In this study, the 1-year cumulative expulsion rate withTCu 380A postplacental device was observed to be 12.3 per100 users, which may be regarded as a standard expulsionrate for immediate postplacental insertion of similar modelsof IUDs.

4. Discussion

Postpartum IUD insertion has been recommended since1967. For many women, it would be convenient to leave thehospital after delivery already protected against unplannedpregnancy. Immediate insertion of an IUD after the deliveryof placenta satis es the basic requirements of any contra-ceptive methods [5,6] .

The results of this study indicate that immediate post-placental insertion of an IUD neither increases theamount of bleeding and/or pain nor increases the risk of infection. These ndings and the low rates of terminationfor other medical reasons support the conclusions of other studies [7] .

In this study, no serious complications, such as uterineperforations or clinically obvious PID, were observed. Re-cent reports suggesting a greater risk of uterine perforationwhen IUDs are inserted in the puerperium period is a furtherreason to give preference to immediate postplacental inser-tion [8,9] .

The immediate postplacental insertion of IUD lost ac-ceptance after a World Health Organization-sponsored mul-ticenter trial reported unacceptably high pregnancy andexpulsion rates [10] . However, recent reviews found betterclinical performance with immediate postplacental insertionof IUD. The present study indicates a very low incidence of pregnancy, in accordance with the latter reports. Thesendings may be reported to be due to the high ef cacy of the CuT 380 IUD and the fact that almost all women werebreastfeeding [10 12] .

In the present study, both cesarean section and vaginaldeliveries were included. Although there are no randomizedcontrolled trials that evaluated IUD insertion at the time of cesarean section delivery, one cohort study found signi -cantly lower expulsion rate with IUD insertion at the time of cesarean delivery than with insertion immediately after birth

[1,13] .In several reports, it was stated that the Cu IUD deviceshad higher expulsion rates when inserted immediately afterthe delivery of placenta, than with delayed postplacentalinsertions. The reasons for the divergence in expulsion ratesaccording to timing are still poorly understood. Moreover,there are controversial data in the literature about the cu-mulative expulsion rates of immediate postplacental inser-tion Cu IUD models. In our series, it was observed after 1year that the cumulative expulsion rate may be regarded asa standard expulsion rate for immediate postplacental inser-tion of Cu IUDs [2,3,14] .

The experience of the clinician performing the insertion

may in uence expulsion rates. The observational data of several reports suggest that the rate of expulsion after post-placental insertion may be governed more by the insertiontechniques than by the shape and size and/or the use of suspension technique [12] .

Continuation rates observed in our series, 75 per 100

users for CuT 380 devices, indicate the acceptability of postplacental insertion [3,6,15] .

5. Conclusion

In fact, the safety of immediate postplacental insertionhas never been questioned seriously and, according toconsensus, this procedure does not enhance the hazard of infection or the rate of uterine perforation. Studies to datehave not shown that IUDs interfere with lactation.

In conclusion, the evidence from this study suggeststhat immediate postplacental insertion of CuT 380 mod-els is an effective, useful, safe, convenient and low-costprocedure for early postpartum contraception. Trials of adequate power are needed to compare immediate post-placental insertion with delayed postplacental and inter-val insertion.

References

[1] Grimes D, Schulz K, Van Vliet H, Stanwood N. Immediate postpartum insertion of intrauterine devices (Cochrane Review). Co-chrane Database Syst Rev 2003;(1):CD003036.

[2] Grimes D, Schulz K, Van Vliet H, Stanwood N. Immediate post-

partum insertion of intrauterine devices. Cochrane Database Syst Rev2001;(2):CD003036.

[3] Xu J, Zhuang L, Yu G. Comparison of two techniques used inimmediate postplacental insertion of TCu 380A intrauterine device:12 month follow up of 910 cases. Zhongjua Fa Chan Ke Za Zhi1997;32:354 7.

[4] Xu JX, Rivera R, Dunson TR, et al. A comparative study of twotechniques used in immediate postplacental insertion (IPPI) of theCopper T-380A IUD in Shanghai, People s Republic of China. Con-traception 1996;54:33 8.

[5] Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partum insertion of intrauterine devices: a Cochrane review. HumReprod 2002;17:549 54.

[6] Thiery M, Van Kets H, Van der Pas H. Immediate post-placental IUDinsertion: the expulsion problem. Contraception 1985;31:331 49.

[7] Welkovic S, Costa LO, Faundes A, de Alencar Ximenes R, Costa CF.Post-partum bleeding and infection after post-placental IUD insertion.Contraception 2001;63:155 8.

[8] O Hanley K, Huber DH. Postpartum IUD: keys for success. Contra-ception 1992;45:351 61.

[9] Xu JX, Reusche C, Burdan A. Immediate postplacental insertion of the intrauterine device: a review of Chinese and the world s experi-ences. Adv Contracept 1994;10:71 82.

[10] World Health Organization. Comparative multicentre trial of threeIUDs inserted immediately following delivery of the placenta. Con-traception 1980;22:9 18.

[11] Tatum HJ, Beltran RS, Ramos R, Van Kets H, Sivin I, Schmidt FH.Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380postpartum intrauterine contraceptive devices: randomized study.Am J Obstet Gynecol 1996;175:1231 5.

281S . C elen et al. / Contraception 69 (2004) 279 282


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[12] Morrison C, Waszak C, Katz K, Diabate F, Mate EM. Clinicaloutcomes of two early postpartum IUD insertion programs in Africa.Contraception 1996;53:17 21.

[13] Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterine con-traceptive device insertion. Cochrane Database Syst Rev 2000;(2):CD001327.

[14] Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterine con-traceptive device insertion. Cochrane Database Syst Rev 2001;(1):CD001327.

[15] Hernandez Valencia M, Becerril Flores LC. Use of modi ed intra-uterine device (IUD) TCu 380 with chromium laments in the im-mediate postpartum. Ginecol Obstet Mex 2000;68:70 6.

282 S . C elen et al. / Contraception 69 (2004) 279 282

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