Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Abstract

BACKGROUND Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes. OBJECTIVE This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes. STUDY DESIGN We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18–40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4–12 weeks’ postpartum. Prespecified exclusion criteria included delivery <37.0 weeks’ gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. RESULTS We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70–86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76–91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, −5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, −4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group. CONCLUSION Our results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device inse...

Society of Family Planning Guidelines: Postplacental insertion of intrauterine devices

“…For the primary outcome of any breastfeeding at 8 weeks postpartum, postplacental insertion was noninferior to delayed insertion (79% vs. 84%, respectively, p= .28). Time to lactogenesis was also noninferior in the postplacental compared to delayed insertion groups (65.3 vs. 63.6 h, p=.61) [81]. Based on the results of this definitive study, we do not recommend withholding the option of postplacental LNG-IUD for breastfeeding women.…”

Provision of immediate postpartum intrauterine contraception after vaginal birth within a public maternity setting: Health services research evaluation

“…No other patient or insertion‐related variables were found to be significant in relation to expulsion risk. Some studies have suggested a higher expulsion rate for the intrauterine system compared with the copper intrauterine device, although the overall evidence is conflicting. Most women in our study received an intrauterine system and we found little evidence of a difference in expulsion rate between the two devices, although further research from larger comparative trials is needed.…”

Immediate postplacental insertion of intrauterine contraceptive device (copper 375) and its complications in term of expulsion, infection and perforation

“…Additionally, postplacental placement at the time of caesarean section has lower expulsion rates than post-placental vaginal insertions. Insertion complications of perforation and infection are not increased by IUD placement at any time during the post-partum period [14,15,18].…”