Elsevier

Contraception

Volume 89, Issue 6, June 2014, Pages 534-539
Contraception

Original research article
Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial,☆☆,

https://doi.org/10.1016/j.contraception.2013.12.007Get rights and content

Abstract

Objective

This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4–8 weeks after delivery.

Study design

This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4–8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery.

Results

Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment.

Conclusions

Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion.

Implications

Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.

Introduction

Many postpartum women do not receive contraception until their postpartum visit, which often does not occur until 6 weeks. This delay may put some women at risk for unintended pregnancy, as many resume sexual activity prior to that visit [1]. The intrauterine device (IUD) may be an ideal method for immediate postpartum administration as it facilitates adequate birth spacing and does not require repeat visits for contraceptive refills. However, the IUD remains underused in the United States, with only 3.5% of US women reporting current use [2]. Barriers to uptake include cost, lack of provider knowledge or availability, two-visit protocols for insertion and misconceptions about IUDs [3], [4], [5], [6]. While little is known about postpartum IUD uptake, one study of adolescents who expressed a desire for an IUD showed multiple barriers to uptake, including outdated eligibility restrictions, long wait times and lack of insurance coverage [7].

Placing an IUD immediately after delivery may help overcome some barriers to uptake. Immediate postplacental insertion of an IUD (within 10 min of delivery of the placenta) has been studied in a number of populations and is practiced worldwide [8]. Nevertheless, few randomized controlled trials (RCTs) compare postplacental insertion to delayed insertion, and we found no published RCTs investigating postplacental insertion at the time of cesarean delivery [8]. While postplacental insertion is safe and effective, expulsion rates are higher compared to those of interval insertion, with expulsion after vaginal delivery higher than that after cesarean delivery [9]. Although expulsion for postplacental insertion after cesarean delivery appears to be higher than that after interval insertion, in some studies, as few as 45%–60% of women return for delayed postpartum IUD placement [9], [10], [11], [12], [13].

In this trial, we designed a novel RCT to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of scheduled cesarean delivery and those with delayed insertion 4–8 weeks after cesarean delivery.

Section snippets

Materials and methods

This randomized, controlled, parallel-group trial was conducted at The University of Chicago Medical Center (UCMC) from May 2007 to July 2010. The NorthShore University HealthSystem Evanston Hospital (EH) site was added due to slow recruitment at UCMC, and the trial was conducted there from April 2009 to January 2011. The trial received Institutional Review Board approval at both sites. Pregnant English-speaking women, aged 18 years and older, with planned cesarean delivery and desiring the

Results

We randomized 42 women, 20 into the postplacental group and 22 into the delayed group. We did not reach our planned sample size due to early termination of the study in response to slow recruitment. Lost to follow-up was higher than anticipated but similar in both groups, overall 33.3% (14/42) (Fig. 1). There were no significant differences in baseline characteristics between groups (Table 1). More women in the postplacental group had the LNG-IUD placed per study protocol (95.0% vs. 81.8%,

Discussion

This RCT compared postplacental and delayed insertion of the LNG-IUD among women undergoing cesarean delivery. We terminated this trial early due to slow recruitment at both sites, and thus, it did not answer the question it was designed to address. The problems with recruitment were likely specific to our own institutions: a change in obstetrical policies resulting in a marked decrease in obstetrical volume soon after recruitment started at UCMC and a relative lack of familiarity with the

Acknowledgment

None.

References (22)

Cited by (0)

Financial support: This research was supported by grants from The Society of Family Planning and an anonymous foundation.

☆☆

Conflict of interest statement: All authors have no conflict of interests to disclose.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00635362.

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