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Placement of an intrauterine device within 48 hours after second-trimester medical abortion: a randomized controlled trial
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centrum för klinisk forskning Dalarna. Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.;Falun Cent Hosp, Dept Obstet & Gynecol, Falun, Sweden..ORCID-id: 0000-0001-6061-3982
Univ Gothenburg, Dept Obstet & Gynecol, Gothenburg, Sweden..
Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.;Dalarna Univ, Sch Hlth & Welf, Falun, Sweden.;Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden..
Lund Univ, Dept Clin Sci, Lund, Sweden.;Skane Univ Hosp, Dept Gynaecol & Obstet, Lund, Sweden..
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2024 (Engelska)Ingår i: American Journal of Obstetrics and Gynecology, ISSN 0002-9378, E-ISSN 1097-6868, Vol. 231, nr 5, s. 530e1-530e8Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

BACKGROUND: International guidelines recommend placement of intrauterine devices immediately after second-trimester medical abortion, but evidence concerning the optimal time for intrauterine device placement is lacking from clinical trials. OBJECTIVE: This study aimed to investigate effectiveness, safety, and acceptability of intrauterine device placement within 48 hours, compared with placement at 2 to 4 weeks after second-trimester medical abortion. We hypothesized that intrauterine device placement within 48 hours would be superior compared with placement at 2 to 4 weeks after the abortion, in terms of the proportion of intrauterine device use after 6 months, with maintained safety and acceptability. STUDY DESIGN: In this open-label, randomized, controlled, superiority trial, we recruited participants at 8 abortion clinics in Sweden. Eligible participants were aged >= 18 years, requesting medical abortion with gestation >= 85 days, and opting for use of a postabortion intrauterine device. Participants were randomized (1:1) to intrauterine device placement either within 48 hours of complete abortion (intervention) or after 2 to 4 weeks (control). Our primary outcome was self-reported use of an intrauterine device after 6 months. Secondary outcomes included expulsion rates, pain at placement, adverse events and complications, acceptability, and subsequent pregnancies and abortions. Differences in nonnormal 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 <.05 was considered statistically significant. Group differences are presented by modified intention-to-treat and per-protocol analyses. RESULTS: Between January 2019 and June 2022, we enrolled 179 participants, of whom 90 were assigned to the intervention and 89 to the control arm. Enrollment was prematurely stopped after an interim analysis exceeded a predefined intrauterine device expulsion rate of 20%. According to modified intention-to-treat analysis, use of intrauterine device after 6 months was 50.7% (34/67) in the intervention group vs 71.6% (48/ 67) in the control group (proportion difference, 20.9%; 95% confidence interval, 4.4%-35.9%; P=.02). The intrauterine device expulsion rate was 30.1% (22/73) in the intervention group vs 2.9% (2/70; P<.001) in the control group. Other adverse events were rare and patient acceptability was high in both groups. CONCLUSION: Intrauterine device placement within 48 hours after second-trimester medical abortion was nonsuperior in terms of the proportion of intrauterine device use after 6 months when compared with placement after 2 to 4 weeks. Placement within 48 hours after second- trimester abortion can be used in selected individuals after counseling on expulsion risk.

Ort, förlag, år, upplaga, sidor
Elsevier, 2024. Vol. 231, nr 5, s. 530e1-530e8
Nyckelord [en]
health services accessibility, induced abortion, intrauterine device expulsion, long-acting reversible contraception, medicated intra-uterine devices, postabortion contraception, repeated abortion seekers, contraception, copper intrauterine devices, family planning services
Nationell ämneskategori
Gynekologi, obstetrik och reproduktionsmedicin
Identifikatorer
URN: urn:nbn:se:uu:diva-543285DOI: 10.1016/j.ajog.2024.05.041ISI: 001347132200001PubMedID: 38796039Scopus ID: 2-s2.0-85195668981OAI: oai:DiVA.org:uu-543285DiVA, id: diva2:1918810
Tillgänglig från: 2024-12-06 Skapad: 2024-12-06 Senast uppdaterad: 2025-02-11Bibliografiskt granskad

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