Long-Acting Reversible Contraception With Contraceptive Implants and Intrauterine Devices

Averbach, Sarah; Hofler, Lisa G.

doi:10.1001/jama.2022.5448

Cited by 4 publications

(3 citation statements)

References 10 publications

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“…Similarly, more malpositioned IUDs were observed in the early placement group compared with the interval group; the clinical significance of malpositioned IUDs is also unclear, especially in the absence of symptoms. 18 However, an ectopic pregnancy was diagnosed in a participant with a malpositioned hormonal IUD. This study observed higher risk differences for expulsion in the per-protocol analysis.…”

Section: Discussionmentioning

confidence: 99%

“…It is unknown whether partially expelled IUDs retain some effectiveness and whether this differs by IUD type (copper vs hormonal); however, an intrauterine pregnancy was diagnosed in a participant with a partially expelled copper IUD. Similarly, more malpositioned IUDs were observed in the early placement group compared with the interval group; the clinical significance of malpositioned IUDs is also unclear, especially in the absence of symptoms . However, an ectopic pregnancy was diagnosed in a participant with a malpositioned hormonal IUD.…”

Section: Discussionmentioning

confidence: 99%

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Early vs Interval Postpartum Intrauterine Device Placement

Averbach

Kully

Hinz

et al. 2023

JAMA

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ImportanceThe early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits.ObjectiveTo determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit.Design, Setting, and ParticipantsIn this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum.InterventionsEarly postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum.Main Outcomes and MeasuresThe primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome.ResultsAmong 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, −0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, −4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group.Conclusions and RelevanceEarly IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement.Trial RegistrationClinicalTrials.gov Identifier: NCT03462758

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Early vs Interval Postpartum Intrauterine Device Placement

Averbach

Kully

Hinz

et al. 2023

JAMA

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“…In Reply We agree with Drs Gao and Zhang that understanding the effectiveness of IUDs to prevent pregnancy is important to adequately weigh the risks and benefits of early postpartum IUD placement. Although IUDs are well known to be highly effective, our study was not designed to adequately assess the effectiveness of early postpartum IUDs for pregnancy prevention. We did report all pregnancies in the trial; 2 pregnancies occurred during use of an IUD among the 294 participants who received an IUD and completed 6-month follow-up (1 in the early placement group and 1 in the interval placement group).…”

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IUD Expulsion Rates After Early Postpartum vs Interval Placement—Reply

Averbach

Vaida

Hofler

2023

JAMA

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To the Editor A recent study 1 found that the risk of complete intrauterine device (IUD) expulsion in individuals who underwent early postpartum IUD placement (2-4 weeks postpartum) was not inferior to that in individuals who underwent interval IUD placement (6-8 weeks postpartum). However, this conclusion must be viewed with cautious for several statistical reasons.First, as noninferiority trials are increasingly being used to evaluate the safety of a new treatment, an efficacy comparison is urgently needed to assess the risk-benefit ratio 2 ; however, in practice this is often not performed. In this study, 1 IUD complete expulsion was the primary safety end point of postpartum IUD placement, so the rates of effective contraception of IUD at 6-month follow-up should be addressed to quantify the risk and benefit.Second, a relative noninferiority margin of 6% was arbitrarily selected for the risk of complete expulsion, and the upper bound of a 2-sided 95% CI was 5.7%, which was close to the prespecified noninferiority margin, raising concerns about the power of the result. 3,4 In addition, given that complete expulsion after IUD insertion was rare (3 of 149 in the early placement group and 0 of 145 in the interval placement group), high rates of loss to followup (9.5%) could lead to an underestimation of rates of expulsion and bias the result toward noninferiority.Third, this randomized trial consisted of patients with IUD placement from 4 US medical centers and hence had limited generalizability.

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