Immediate versus delayed insertion of the IUD following medical abortion at 17–20 weeks’ gestation: Preliminary results from a randomized controlled trial

Introduction The risk-benefit ratio of immediate compared with delayed insertion of an intrauterine device (IUD) following medical abortion (MA) at 17-20 weeks gestation is largely unknown. We report preliminary findings from a randomized controlled trial on IUD use at 6 weeks after immediate compared to delayed insertion, following medical abortion at this gestation. Method This 2-arm randomized controlled trial was conducted in Cape Town, South Africa. Between August 2018 and June 2019, we consented and randomized 114 women admitted for MA. The immediate arm had an IUD inserted prior to discharge; the delayed arm was referred for insertion 3 weeks later at a primary healthcare facility. Follow-up involved in-person clinical examination and ultrasound 6 weeks after MA. Non-attendees were contacted by phone. Follow-up at 6 months is ongoing. Our main outcome was use of the original IUD at 6 weeks, defined as adequate placement without indication for removal, according to intention-to-treat (ITT). Secondary outcomes include 1) use of any IUD after the 6-week follow-up period (ITT) and 2) expulsion, intracervical and symptomatic malposition at 6 weeks after MA (per protocol [PP]). Results There were 55 women in the immediate arm and 57 in the delayed arm (ITT). At 6 weeks we followed up 98/112 women (88% in each study arm). There was adequate placement of the original IUD in 53% of women in the immediate arm versus 23% in the delayed arm. At the end of the 6-week follow-up period 73% in the immediate arm versus 40% in the delayed arm had either the original IUD, a replacement IUD, or an IUD placed for the first time at follow up. Of those who had an IUD placed, 36% (immediate) versus 14% (delayed) had complete expulsion, or removal of the IUD due to malposition (PP). Conclusions Insertion of an IUD immediately after late second trimester MA results in increased use after 6 weeks compared to delayed insertion. Expulsion rates are higher than interval insertion and higher than for immediate insertion after MA at earlier gestational ages.