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

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 insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast-feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast-feeding women planning to use the levonorgestrel intrauterine device.

Immediate postpartum intrauterine device and implant program outcomes: a prospective analysis.

BACKGROUND: In-hospital placement of intrauterine devices and contraceptive implants following vaginal and cesarean delivery is increasingly popular and responds to maternal motivation for highly effective postpartum contraception. Immediate postpartum intrauterine device insertion is associated with higher expulsion than interval placement, but emerging evidence suggests that the levonorgestrel intrauterine device may have a higher expulsion rate than the copper intrauterine device. OBJECTIVE: This study evaluated in-hospital provision, expulsion, and 6-month continuation of immediate postpartum copper T380 intrauterine devices, levonorgestrel intrauterine devices, and contraceptive implants. STUDY DESIGN: We offered enrollment in this prospective observational trial to women presenting to the University of Utah labor and delivery unit from October 2013 through February 2016 who requested an intrauterine device or implant for postpartum contraception during prenatal care or hospitalization at the time of delivery. Following informed consent, participants completed questionnaires prior to hospital discharge and at 3 and 6 months postpartum. Data on expulsions at 6 months were validated by chart abstraction. RESULTS: During the study period, 639 patients requested a postpartum intrauterine device or implant and 350 patients enrolled in prospective follow-up prior to discharge from the hospital. Among enrollees, 325 (93%) received their preferred contraceptive device prior to hospital discharge: 88 (27%) copper intrauterine device users, 123 (38%) levonorgestrel intrauterine device users, and 114 (35%) implant users. Participants predominantly were Hispanic (90%), were multiparous (87%), reported a household income <$24,000 per year (87%), and underwent a vaginal delivery (77%). At 6 months postpartum, 289 of 325 device recipients (89%) completed follow-up. Among levonorgestrel intrauterine device users 17% reported expulsions relative to 4% of copper intrauterine device users. The adjusted hazard ratio for expulsion was 5.8 (confidence interval, 1.3-26.4). There was no statistically significant difference in expulsions by delivery type or continuation by device type. Among the 21 women who experienced intrauterine device expulsions, 14 (67%) requested a replacement long-acting reversible contraception device for contraception. The 6-month device continuation was ≥80% for all device types. CONCLUSION: An immediate postpartum long-acting reversible contraception program effectively provides women who desire highly effective reversible contraceptive devices with their method of choice prior to hospital discharge. Immediate postplacental levonorgestrel intrauterine device users have higher expulsion rates than copper intrauterine device users, but >8 of 10 women initiating an intrauterine device or implant continue use at 6 months postpartum.