Trial reportActa obstetricia et gynecologica Scandinavica2022
Effectiveness, safety and overall satisfaction of early postpartum placement of hormonal IUD compared with standard procedure: An open-label, randomized, multicenter study.
Trial report in Acta obstetricia et gynecologica Scandinavica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- Immediate placement of intrauterine device after second-trimester medical abortion-Secondary outcomes with one-year follow-up.Acta obstetricia et gynecologica Scandinavica · 2026Trial
- Effectiveness, safety and overall satisfaction of early postpartum placement of hormonal IUD compared with standard procedure: An open-label, randomized, multicenter study.Acta obstetricia et gynecologica Scandinavica · 2022Trial
- Post-pregnancy contraception.Reproduction & fertility · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
introductionIn this open-label, randomized controlled, non-inferiority, multicenter study we aimed to study the risk of termination of pregnancy within 1 year postpartum, the safety profile and patient acceptability after early postpartum insertion of a hormonal intrauterine device (LNG-IUS, Mirena®) compared with standard placement 6-8 weeks postpartum. MATERIAL AND
methodsApril 2018 to January 2020 women with uncomplicated vaginal delivery at four urban birth centers in Sweden, were randomized to either early placement within 48 h after delivery (early group) or standard placement 6-8 weeks postpartum (standard group) of a hormonal intrauterine device. The main outcome measure was the proportion of terminations of pregnancies in each group during the first year after placement of the intrauterine device. Registration EudraCT database no. 2017-001945-29.
resultsThe study was prematurely stopped according to the protocol due to an expulsion rate >20% in the early group. No pregnancies occurred. Fifty-two women were randomized to early and 49 women to standard insertion. In the early group, 23/52 (44.2%) of the intrauterine devices were expelled. After expulsion, 10 women chose to have another hormonal intrauterine device placed but still significantly fewer women (39/52, 75%, p = 0.22) in the early group used the hormonal intrauterine device method at study completion. No expulsions occurred in the standard group, but 5/49 (10.2%) requested removal and 41/49 (83.7%, p = 0.22) had used the hormonal intrauterine device method continuously for 1 year.
conclusionsEarly hormonal intrauterine device insertion after vaginal delivery is associated with high expulsion rates. Despite this, a high continuation rate of the hormonal intrauterine device method is seen among women once choosing the method. In the light of high continuation rates, the advantages of early insertion could balance the risk of expulsion for well-informed women.
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