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

BackgroundIntrauterine 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.ObjectiveThis study aimed to investigate if placement of an intrauterine device within 48 hours of completed medical abortion at up to 63 days' gestation leads to higher user rates at 6 months after the abortion compared with placement at 2 to 4 weeks after abortion. Furthermore, we aimed to compare continued use of intrauterine devices, safety, and patient satisfaction between groups.Study DesignWe performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion at up to 63 days' gestation and opting for an intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2 to 4 weeks after abortion (control group). We defined the abortion as complete after bleeding with clots and cessation of heavy bleeding following the use of misoprostol. Patients answered questionnaires at 3, 6, and 12 months. The primary outcome was use of intrauterine device at 6 months postabortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in nonparametric continuous variables were analyzed with the Mann–Whitney U test and differences in dichotomous variables with the chi square or Fisher exact tests. A P value of <.05 was considered statistically significant.ResultsIn the intervention group, 91 of 111 (82%) participants used an intrauterine device at 6 months after the abortion vs 87 of 112 (77.7%) in the control group, with a difference in proportion of 4.3% (95% confidence interval, −0.062 to 0.148; P=.51). Attendance rate and rate of successful intrauterine device placement were similar between the groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score [visual analogue scale], 32.3; standard deviation, 29) compared with the control group (mean pain score [visual analogue scale], 43.4; standard deviation, 27.9; P=.002). Patients preferred their allocated time of placement significantly more often in the intervention group (83/111, 74.8%) than in the control group (70/114, 61.4%; P=.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) than in the control group (15/101, 14.9%; P<.001), and in one patient in the control group a retained gestational sac was found. Three patients in the intervention group and 2 in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. Expulsion during the first 6 months after abortion was experienced by 9 of 97 (9.3%) patients in the intervention group and 4 of 89 (4.5%; P=.25) in the control group. There were no perforations or infections requiring antibiotic treatment.ConclusionPlacement of an intrauterine device within 48 hours after medical abortion at ≤63 days' gestation does not lead to higher user rates at 6 months after the abortion compared with intrauterine device placement at 2 to 4 weeks after abortion. When compared with placement at a follow-up visit after 2 to 4 weeks, intrauterine device placement within 48 hours after early medical abortion seems safe, is preferred by patients, and is associated with lower pain scores. 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. This study aimed to investigate if placement of an intrauterine device within 48 hours of completed medical abortion at up to 63 days' gestation leads to higher user rates at 6 months after the abortion compared with placement at 2 to 4 weeks after abortion. Furthermore, we aimed to compare continued use of intrauterine devices, safety, and patient satisfaction between groups. We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion at up to 63 days' gestation and opting for an intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2 to 4 weeks after abortion (control group). We defined the abortion as complete after bleeding with clots and cessation of heavy bleeding following the use of misoprostol. Patients answered questionnaires at 3, 6, and 12 months. The primary outcome was use of intrauterine device at 6 months postabortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in nonparametric continuous variables were analyzed with the Mann–Whitney U test and differences in dichotomous variables with the chi square or Fisher exact tests. A P value of <.05 was considered statistically significant. In the intervention group, 91 of 111 (82%) participants used an intrauterine device at 6 months after the abortion vs 87 of 112 (77.7%) in the control group, with a difference in proportion of 4.3% (95% confidence interval, −0.062 to 0.148; P=.51). Attendance rate and rate of successful intrauterine device placement were similar between the groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score [visual analogue scale], 32.3; standard deviation, 29) compared with the control group (mean pain score [visual analogue scale], 43.4; standard deviation, 27.9; P=.002). Patients preferred their allocated time of placement significantly more often in the intervention group (83/111, 74.8%) than in the control group (70/114, 61.4%; P=.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) than in the control group (15/101, 14.9%; P<.001), and in one patient in the control group a retained gestational sac was found. Three patients in the intervention group and 2 in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. Expulsion during the first 6 months after abortion was experienced by 9 of 97 (9.3%) patients in the intervention group and 4 of 89 (4.5%; P=.25) in the control group. There were no perforations or infections requiring antibiotic treatment. Placement of an intrauterine device within 48 hours after medical abortion at ≤63 days' gestation does not lead to higher user rates at 6 months after the abortion compared with intrauterine device placement at 2 to 4 weeks after abortion. When compared with placement at a follow-up visit after 2 to 4 weeks, intrauterine device placement within 48 hours after early medical abortion seems safe, is preferred by patients, and is associated with lower pain scores.