No difference in complete expulsion of intrauterine device between early and standard interval postpartum placement
1. In this randomized clinical trial, participants underwent postpartum intrauterine device (IUD) placement at early (14-28 days) or interval (42-56 days) and found no clinically meaningful difference in complete IUD expulsion rates between the groups.
2. Partial expulsion occurred in 9.4% of participants in the early placement group and 7.6% in the interval placement group, not noninferior based on a noninferiority margin of 6%.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Postpartum contraception is typically provided at the 6-week postpartum visit; however, limited evidence supports this practise. An alternative, and perhaps more ideal, time for IUD placement is at 2 to 4 weeks, given that people are already seeing clinicians for well-baby visits, have resumed intercourse by this time, and are finding early postpartum visits more common. Previous studies have found that early postpartum IUD placement is feasible and acceptable, so this randomized clinical trial compared the expulsion rates of IUD between early and interval placement. The primary outcome was complete expulsion at the 6-month postpartum follow-up, which was considered as no IUD present in the uterus on transvaginal ultrasound and either a clinical history consistent with this or radiographic imaging showing no IUD. Secondary outcomes included partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy and IUD use at 6 months. Among 404 participants, early IUD placement was noninferior for complete expulsion compared to interval IUD placement. A limitation of this study was that a larger percentage of the subjects did not receive an IUD insertion as planned, which could lead to potential variations between the groups that the study lacked sufficient power to identify. The clinical implication of this study is that clinicians and patients can use this knowledge to engage in shared decision-making to evaluate when the best timing for IUD placement is for the patient based on their individual values and preferences.
Click to read the study in JAMA
In-Depth [randomized clinical trial]: This randomized non-inferiority trial included 404 participants (mean [SD] age, 29.9 [5.4] years). The study was conducted at four academic centers in the United States from March 2018 to July 2021. Participants were randomized to either the early placement group (n = 203) or interval placement group (n = 201). Of these participants, 294 (73%) individuals received an IUD and completed the 6-month follow-up; the remaining 27% were lost to follow-up or did not have an IUD placed. All participants underwent a 6-week postpartum visit and a 6-month study visit with a clinician blinded to their group assignment. Overall, the rates of complete expulsion were 2.0% (95% CI, 0.4%-5.8%) for early postpartum IUD placement at 2 to 4 weeks and 0% (95% CI, 0.0%-2.5%) for interval IUD placement at 6-8 weeks. The difference between the groups was 2.0% (95% CI, −0.5 to 5.7; P = .04), which was less than the prespecified margin of 6%, and thus, early placement was considered noninferior to interval placement. For secondary outcomes, early placement had an increased absolute risk of partial expulsion at 9.4% (95% CI, 5.2%-15.3%) compared to interval placement at 7.6% (95% CI, 3.9%-13.2%); however, the difference did not meet the prespecified criterion for non-inferiority of 6% (1.8% [95% CI, −4.8 to 8.6]; P = .22).
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