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Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

ABSTRACT: Objective:The objective was to describe the sonographic position of copper intrauterine devices (IUDs) 6 months after insertion during cesarean delivery. Study design:This prospective, observational study followed participants who received a copper IUD during cesarean delivery. We performed pelvic examination at 6?weeks and 6?months and sonography at 6?months to determine IUD position. Patients had additional examinations as needed to address complications. Results:Sixty-nine participants provided outcomes through 6 months: 41 (59%) had correctly positioned IUDs, 21 (30%) had malpositioned intrauterine IUDs, 5 experienced expulsion (3 partial, 2 complete), and 2 had elective removal; 52 (75%) had missing strings. Missing strings at 6 weeks predicted an incorrect IUD position in 22 of 52 participants (positive predictive value 42%), and visible or palpable strings predicted a correct IUD position in 7 of 12 participants (negative predictive value 58%). Conclusion:Although 59% of copper IUDs placed during cesarean were correctly positioned at 6?months, nearly one third were malpositioned. Implications:Ultrasound may be indicated for patients receiving a copper IUD during cesarean delivery as checking IUD strings alone does not assure correct placement. Providers offering postpartum IUDs should ensure that appropriate processes for the evaluation and management of devices with missing strings or abnormal position are available to all patients regardless of insurance status.

SUBMITTER: Gurney EP

PROVIDER: S-EPMC7644571 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

Gurney Elizabeth P EP McAllister Arden A Lang Britt B Schreiber Courtney A CA Sonalkar Sarita S

Contraception: X 20201009

<h4>Objective</h4>The objective was to describe the sonographic position of copper intrauterine devices (IUDs) 6 months after insertion during cesarean delivery.<h4>Study design</h4>This prospective, observational study followed participants who received a copper IUD during cesarean delivery. We performed pelvic examination at 6 weeks and 6 months and sonography at 6 months to determine IUD position. Patients had additional examinations as needed to address complications.<h4>Results</h4>Sixty-ni ...[more]

PMID: 33196037

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Project description:BackgroundSeveral studies have investigated the effectiveness of intrauterine device placement at cesarean delivery as a contraceptive method. However, national-level use and outcomes of a postplacental intrauterine device at cesarean delivery are currently understudied in the United States.ObjectiveThis study aimed to examine the trends, characteristics, and outcomes of patients who received a postplacental intrauterine device at cesarean delivery.Study designThis retrospective cohort study used the National Inpatient Sample. The study cohort included patients who underwent cesarean delivery from October 2015 to December 2018. The exclusion criteria included hemorrhage, chorioamnionitis, uterine anomaly, hysterectomy, and permanent surgical sterilization. Eligible cases were grouped on the basis of the use of a postplacental intrauterine device at cesarean delivery. The primary outcome measures were temporal trends and characteristics associated with the use of a postplacental intrauterine device at cesarean delivery, assessed using the generalized estimating equation model in multivariable analysis. The secondary outcome measure was perioperative morbidity (leukocytosis, endometritis, myometritis, and sepsis). Propensity score matching was used to balance the baseline characteristics.ResultsAmong 2,983,978 patients who met the inclusion criteria, 10,145 patients (0.3%) received a postplacental intrauterine device at cesarean delivery. The use of a postplacental intrauterine device increased from 0.1% in the fourth quarter of 2015 to 0.6% in the fourth quarter of 2018 (P<.001). In a multivariable analysis, the use of a postplacental intrauterine device increased by 14% every quarter-year (adjusted odds ratio, 1.14; 95% confidence interval, 1.13-1.15). In addition, (1) patient characteristics of young age, non-White race, obesity, tobacco use, lowest quartile median household income, and insured with Medicaid; (2) hospital characteristics of large bed capacity and urban teaching setting in Northeast region; and (3) pregnancy characteristics of early gestational age at cesarean delivery, hypertensive disease, previous cesarean delivery, multifetal pregnancy, grand multiparity, placenta previa, and nonelective cesarean delivery represented the independent characteristics associated with the use of a postplacental intrauterine device (all P<.05). A regression tree model identified 35 discrete patterns of the use of a postplacental intrauterine device based on 8 factors (time, race or ethnicity, primary expected payer, obesity, hospital bed capacity, hospital teaching status, hospital region, and previous cesarean delivery). There were 9 patterns, representing 8.8% of the study population, exhibiting a use rate of ≥1.0%, whereas there were 7 patterns, representing 16.0% of the study population, exhibiting no use of a postplacental intrauterine device (absolute rate difference from the highest group to the lowest group, 4.7%). In a propensity score-matched model, postplacental intrauterine device placement at cesarean delivery was not associated with increased risk of measured morbidity (any, 1.8% vs 1.7%; odds ratio, 1.06; 95% confidence interval, 0.66-1.69; P=.812), including postpartum endometritis (1.2% vs 1.0%; odds ratio, 1.19; 95% confidence interval, 0.67-2.14; P=.554).ConclusionThe use of a postplacental intrauterine device at cesarean delivery increased significantly in recent years in the United States.

Project description: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.

Project description:OBJECTIVE:To compare, using decision analysis methodology, the 1-year probability of pregnancy after intended postplacental intrauterine device (IUD) insertion with intended delayed insertion at an outpatient postpartum visit (delayed postpartum placement). METHODS:We developed an evidence-based decision model with the primary outcome of 1-year probability of pregnancy. We compared 1-year probability of pregnancy after intended postplacental or intended delayed postpartum IUD placement. We obtained estimates from the literature for the proportions of the following: mode of delivery, successful IUD placement, IUD type, postpartum visit attendance, IUD expulsion, IUD discontinuation, and contraceptive use, choice, and efficacy after IUD discontinuation. We performed sensitivity analyses and a Monte Carlo simulation to account for variations in proportion estimates. RESULTS:One-year probabilities of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a postplacental IUD after vaginal birth and 1,250,000 women intending to receive a postplacental IUD after cesarean birth were 17.3% and 11.2%, respectively; the 1-year probability of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a delayed postpartum IUD was 24.6%. For delayed postpartum IUD placement to have effectiveness equal to postplacental placement, 91.4% of women delivering vaginally and 99.7% of women delivering by cesarean would need to attend postpartum care. Once placed, the effectiveness of postplacental IUDs was lower than that of delayed postpartum IUDs: 1-year probabilities of pregnancy after IUD placement at a vaginal birth, cesarean birth, and an outpatient postpartum visit were 15.4%, 6.6%, and 3.9%, respectively. CONCLUSION:After accounting for factors that affect successful IUD placement and retention, this decision model indicates that intended postplacental IUD insertion results in a lower 1-year probability of pregnancy as compared with intended delayed postpartum IUD insertion.

Project description:ObjectiveTo assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator.MethodsInstitutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns.ResultsA total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06-1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0-3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13.ConclusionThe novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial.Clinical trial registrationClinicalTrials.gov, NCT02446821.Funding sourceSebela Pharmaceuticals, Inc.

Project description:The contraceptive effectiveness of intrauterine devices has been attributed in part to effects of a foreign body reaction on the endometrium. We performed this study to identify compare the effects on the endometrial transcriptome of intrauterine devices and combined oral contraceptives, to better understand their mechanisms of action. We collected endometrial and cervical biopsies from women using the levonorgestrel-intrauterine device, copper intrauterine device or levonorgestrel-containing combined oral contraceptives, and from women not using contraceptives (control group). Transcriptional profiling was performed with Affymetrix arrays, Principal Component Analysis and the bioconductor package limma. Pathway analysis was performed using EnrichR and Reactome 2016. In endometrial samples from copper intrauterine device users (n=13), there were no genes with statistically significant differential expression compared to controls (n=11), whereas in levonorgestrel-intrauterine device users (n=11), 2509 genes were significantly dysregulated and mapped onto several immune and inflammatory pathways. In combined oral contraceptive users (n=12), 133 genes were significantly dysregulated and mapped predominantly onto pathways involving regulation of metal ions. Both levonorgestrel-intrauterine device and combined oral contraceptive use were associated with significant downregulation of members of the metallothionein gene family. In cervical samples, none of the groups showed statistically significant differential gene expression compared to controls. In conclusion, hormonal and copper intrauterine devices differ significantly in their effects on the endometrial transcriptome, with endometrium from copper intrauterine device users being indistinguishable from luteal phase endometrium. These results suggest that the contraceptive mechanisms of intrauterine devices are unlikely to rely on a common pathway involving a foreign body reaction in the endometrium.

Dataset Information

Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

Publications

Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

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