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Placement of an intrauterine device within 48 hours after early medical abortion—a randomized controlled trial
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 intra...
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Published in: | American journal of obstetrics and gynecology 2023-01, Vol.228 (1), p.53.e1-53.e9 |
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Main Authors: | , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | 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 |
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ISSN: | 0002-9378 1097-6868 1097-6868 |
DOI: | 10.1016/j.ajog.2022.07.063 |