Dataset Information

Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial.

ABSTRACT:

Background

Today, a large proportion of early abortions are medical terminations, in accordance to the woman's choice. Intrauterine contraceptives (IUC) provide highly effective, reversible, long-acting contraception. However, the effects of timing of IUC insertion after medical abortion are not known.

Methods

Women undergoing medical abortion with mifepristone and misoprostol up to 63 days gestation and opting for IUC were randomised to early insertion (day 5-9 after mifepristone) or delayed (routine) insertion (at 3-4 weeks after mifepristone). The primary outcome was the rate of IUC expulsion at six months after IUC insertion.

Results

A total of 129 women were randomized, and 116 women had a successful IUC insertion. There was no difference in expulsion rate between early (9.7%) vs. delayed (7.4%) IUC insertion (risk difference -9.2-13.4). Furthermore, 1.5% of women randomized to early and 11.5% to delayed insertion did not attend the follow up (proportion difference 10.0%, 95% CI: 1.8-20.6%, p?=?0.015), and a higher proportion of women (41%) had had unprotected intercourse prior to returning for insertion in the delayed group compared with the early group (16%) (p?=?0.015). Adverse events were rare and did not differ between the groups.

Conclusions

Early insertion of IUC after medical abortion was safe and well tolerated with no increased incidence for expulsions or complications. Women were more likely to return for the IUC insertion if scheduled early after the abortion, and less likely to have had an unprotected intercourse prior to the IUC insertion. Early insertion should be offered as a routine for women undergoing first trimester medical abortion.

Trial registration

ClinicalTrials.gov NCT01537562.

SUBMITTER: Saav I

PROVIDER: S-EPMC3498342 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial.

Sääv Ingrid I Stephansson Olof O Gemzell-Danielsson Kristina K

PloS one 20121114 11

<h4>Background</h4>Today, a large proportion of early abortions are medical terminations, in accordance to the woman's choice. Intrauterine contraceptives (IUC) provide highly effective, reversible, long-acting contraception. However, the effects of timing of IUC insertion after medical abortion are not known.<h4>Methods</h4>Women undergoing medical abortion with mifepristone and misoprostol up to 63 days gestation and opting for IUC were randomised to early insertion (day 5-9 after mifepristone ...[more]

PMID: 23155432

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Project description:ObjectivesTo compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.DesignRandomised controlled trial with 1:1 allocation.SettingCommunity abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.ParticipantsThe trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.Primary and secondary outcome measuresPrimary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.Secondary outcomessatisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.ResultsPrimary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).ConclusionsTelemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.Trial registration numberNCT04139382.

Project description:BackgroundImmediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes.ObjectiveThis study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes.Study designWe conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18-40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4-12 weeks' postpartum. Prespecified exclusion criteria included delivery <37.0 weeks' gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention.ResultsWe met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70-86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76-91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, -5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, -4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group.ConclusionOur results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast-feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast-feeding women planning to use the levonorgestrel intrauterine device.

Project description:IntroductionAlthough primary care practitioners are the main providers of long-acting reversible contraception (LARC) and early medical abortion (EMA) in Australia, few provide these services. A professional community of practice (CoP) has the potential to improve LARC and EMA provision through evidence-based guidance, expert support and peer-to-peer engagement.The primary objective is to establish, implement and evaluate an innovative, multidisciplinary online CoP (AusCAPPS Network) to increase LARC and EMA services in Australian primary care. Secondary objectives are to (1) increase the number of general practitioners (GPs) and pharmacists certified to provide or dispense EMA, respectively, (2) increase LARC and EMA prescription rates and, (3) improve primary care practitioners' knowledge, attitudes and provision of LARC and EMA.Methods and analysisA stakeholder knowledge exchange workshop (KEW) will be conducted to inform the AusCAPPS Network design. Once live, we aim to reach 3000 GPs, practice nurses and community pharmacists members. Changes in the number of GPs and pharmacists certified to provide or dispense EMA, respectively, and changes in the number of LARCs and EMAs prescribed will be gleaned through health service data. Changes in the knowledge attitudes and practices will be gleaned through an online survey with 500 individuals from each professional group at baseline and 12 months after members have joined AusCAPPs; and experiences of the AusCAPPS Network will be evaluated using interviews with the project team plus a convenience sample of 20 intervention participants from each professional group. The project is underpinned by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, and a realist framework will inform analysis.Ethics and disseminationEthical approval was received from the Monash University Human Research Ethics Committee (No. 28002). Dissemination will occur through KEWs, presentations, publications and domestic and international networks.Trial registration numberACTRN12622000655741.

Dataset Information

Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial.

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