Placement of an intrauterine device within 48 hours after early medical abortion : a randomized controlled trial

BACKGROUND: Intrauterine devices are safe, well tolerated and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception. OBJECTIVE: To study if placement of an intrauterine device within 48 hours of completed medical abortion up to 63 days' gestation leads to higher user rates at six months after the abortion compared with placement at two to four weeks after abortion. Furthermore, to compare continued use of intrauterine devices, safety and patient satisfaction between groups. STUDY DESIGN: We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion up to 63 days' gestation and opting for intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2-4 weeks after abortion (control group). We defined the abortion as complete after bleeding of clots and cessation of heavy bleeding following use of misoprostol. Patients answered questionnaires at 3, 6 and 12 months. Primary outcome was use of intrauterine device at 6 months post abortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in non-parametric continuous variables were analyzed by the Mann-Whitney U-test and differences in dichotomous variables were analyzed by Chi square test or Fisher's exact test. A p-value of < 0.05 was considered statistically significant. RESULTS: In the intervention group, 91/111 (82%) used an intrauterine device at six months after the abortion, compared to 87/112 (77.7%) in the control group with a difference in proportion of 4.3% (95% CI -0.062, 0.148, p=0.51). Attendance rate and rate of successful intrauterine device placement were similar between groups. Patients in the int
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