Postplacental or delayed levonorgestrel intrauterine device insertion and breast-feeding duration.
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ABSTRACT: Background
The objective of this study was to assess the effect of timing of postpartum levonorgestrel-releasing intrauterine device (IUD) insertion on breast-feeding continuation.Study design
Women interested in using a levonorgestrel IUD postpartum were randomized to immediate postplacental insertion (postplacental group) or insertion 6-8 weeks after vaginal delivery (delayed group). Duration and exclusivity of breast-feeding were assessed at 6-8 weeks, 3 months, and 6 months postpartum. Only women who received an IUD were included in this analysis.Results
Breast-feeding was initiated by 32 (64%) of 50 of women receiving a postplacental IUD and 27 (58.7%) of 46 of women receiving a delayed IUD (p=.59). More women in the delayed group compared with the postplacental group continued to breast-feed at 6-8 weeks (16/46 vs. 15/50, p=.62), 3 months (13/46 vs. 7/50, p=.13), and 6 months postpartum (11/46 vs. 3/50, p=.02). The results did not differ when only women who initiated breast-feeding or only primiparous women with no prior breast-feeding experience were analyzed.Conclusions
Immediate postplacental insertion of the levonorgestrel IUD is associated with shorter duration of breast-feeding and less exclusive breast-feeding. Further studies on the effects of early initiation of progestin-only methods on women's lactation experience are needed.
SUBMITTER: Chen BA
PROVIDER: S-EPMC3202348 | biostudies-literature | 2011 Nov
REPOSITORIES: biostudies-literature
Publications
Postplacental or delayed levonorgestrel intrauterine device insertion and breast-feeding duration.
Chen Beatrice A BA Reeves Matthew F MF Creinin Mitchell D MD Schwarz E Bimla EB
Contraception 20110416 5
<h4>Background</h4>The objective of this study was to assess the effect of timing of postpartum levonorgestrel-releasing intrauterine device (IUD) insertion on breast-feeding continuation.<h4>Study design</h4>Women interested in using a levonorgestrel IUD postpartum were randomized to immediate postplacental insertion (postplacental group) or insertion 6-8 weeks after vaginal delivery (delayed group). Duration and exclusivity of breast-feeding were assessed at 6-8 weeks, 3 months, and 6 months p ...[more]
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Project description:To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device (IUD) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6-8 weeks postpartum.We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD. Patients were randomly assigned when admitted in labor to postplacental or delayed IUD insertion. The women followed up in person at 6-8 weeks and 6 months and were contacted by telephone at 3 months. Women were ineligible for a study IUD postenrollment for intrapartum events including infection, hemorrhage, and cesarean delivery; these women were contacted by phone at 3 and 6 months. Expelled IUDs were replaced per patient preference.Successful IUD placement occurred in 50 of 51 participants (98.0%) and 46 of 51 participants (90.2%) in the postplacental and delayed groups, respectively (P=.2). Expulsion within 6 months occurred in 12 of 50 (24.0%; 95% confidence interval [CI], 13.1-38.2) and two of 46 (4.4%; 95% CI 0.5-14.8) participants, respectively (P=.008). Intrauterine device use at 6 months was 43 of 51 (84.3%; 95% CI 71.4-93.0) and 39 of 51 (76.5%; 95% CI 62.5-87.2), respectively (P=.32). For ineligible patients, only 11 of 41 (26.8%) women were using IUDs at 6 months and two (4.9%) had become pregnant.Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs. Expulsions are significantly higher with postplacental compared with delayed IUD placement. Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00476021.I.
| S-EPMC3104850 | biostudies-literature
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.
| S-EPMC6040814 | biostudies-literature
Project description:OBJECTIVE:To determine the association between provider training level and postplacental intrauterine device (IUD) outcomes following insertion instruction by email only. STUDY DESIGN:We conducted a single-center chart review of demographics, insertion and clinical outcomes within 6 months of delivery for 116 patients who underwent postplacental levonorgestrel 52?mg IUD placement from October 1, 2016, to March 31, 2017. RESULTS:We confirmed IUD retention, removal or expulsion in 87 of 116 (75.0%) patients by 6 months after delivery. Complete expulsion or removal for malposition occurred in 20 (23.0%) patients and more frequently after vaginal than cesarean delivery (30.2% vs. 4.2%, OR 9.93 [95% CI 1.25-78.96]) and when a postgraduate year (PGY) 1 physician placed the IUD compared to a PGY 2-4 or attending physician (37.5% vs. 14.5%, OR 3.52 [95% CI 1.25-9.94]). CONCLUSION:Postplacental levonorgestrel 52?mg IUD expulsion rates are associated with provider training level as well as delivery route, though the individual association of each of these factors is difficult to ascertain given the high degree of collinearity between these two variables in our study.
| S-EPMC6351181 | biostudies-literature
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.
| S-EPMC6328318 | biostudies-literature
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.
| S-EPMC9898742 | biostudies-literature
Project description:Study objectiveIntrauterine device (IUD) utilization in the United States is low among adolescent and young adult women. Longer procedure duration has been proposed as one potential barrier to IUD insertion in this population. We hypothesized that procedure duration would be longer in adolescents compared to young adult women.Design, setting, and participantsThis study was a secondary analysis of a randomized clinical trial comparing the effectiveness of a lidocaine vs sham paracervical nerve block for pain control during levonorgestrel 13.5 mg IUD insertion. Adolescent and young adult women ages 14-22 years were recruited from 3 outpatient academic sites in Philadelphia, Pennsylvania.Interventions and main outcome measuresPain scores were recorded at 7 steps during the procedure from speculum insertion through removal. Time stamps associated with each step were used to calculate the overall procedure duration. Cumulative IUD insertion procedure duration was estimated using the Kaplan-Meier method.ResultsNinety-five women enrolled. Nineteen (19/95, 20%) were ages 14-17 and 76 (76/95, 80%) were ages 18-22 years. The median procedure duration (seconds ± interquartile range) was longer for adolescents than for young adults (555 ± 428 seconds vs 383 ± 196 seconds; P = .008). After adjusting for study site, the difference in expected median procedure duration between age groups was not significant (P = .3832).ConclusionThe difference in duration of IUD insertion procedures in adolescent and young adult women is not clinically or statistically significant. Providers should not withhold IUDs from appropriate adolescent and young adult women on the basis of age alone.
| S-EPMC6570557 | biostudies-literature
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.
2020-04-29 | GSE137765 | GEO
Project description:OBJECTIVES:Studies have shown that immediate postpartum initiation of long-acting reversible contraception (LARC) methods leads to increased utilization of LARC and prevention of unintended pregnancies. It is unclear if immediate postpartum levonorgestrel-releasing intrauterine device (LNG-IUD) insertion has an effect on breastfeeding success. STUDY DESIGN:This study was a secondary analysis of a randomized trial that compared intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean IUD placement with women who planned for interval IUD placement at 6 or more weeks postpartum. This parallel, 1:1, nonblinded randomized trial was conducted between March 2012 and June 2014 at the University of North Carolina Women's Hospital. We recruited pregnant women aged 18-45 years who were undergoing a cesarean delivery and desired an IUD for contraception postpartum. RESULTS:We received breastfeeding information from 63 women who desired to use a LNG-IUD. A proportion analysis demonstrated that there was no difference in the proportion of women breastfeeding at any of the three time points, 6, 12, and 24 weeks, following placement. This remained true after adjusting for age, parity, and ethnicity. CONCLUSION:This study adds to the existing body of evidence that shows that most women are able to successfully breastfeed after immediate postpartum LNG-IUD placement. Women should be encouraged to breastfeed, and the desire to breastfeed should not preclude the initiation of a postplacental IUD. This study provides reassurance that immediate postpartum LNG-IUD placement does not adversely affect breastfeeding; however, more high-quality data are needed on the impact of hormonal IUDs on breastfeeding outcomes.
| S-EPMC6306674 | biostudies-literature
Project description:ObjectiveTo evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions.MethodsInvestigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S. centers in a prospective trial. Participants had up to three screening cycles with menstrual product collection for alkaline hematin blood-loss measurements. Investigators enrolled those with two menses with blood loss of 80 mL or more (values averaged for baseline blood loss), placed the IUD, and followed participants for up to six 28-day cycles. Participants collected any menstrual products used during cycles 3 and 6 for blood-loss measurement. We evaluated outcomes in participants with at least one follow-up assessment for the primary outcome of median absolute blood-loss change and, secondarily, treatment success , defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline. We evaluated exploratory outcomes of differences in blood-loss changes by BMI and parity using Wilcoxon rank sum test.ResultsOf 105 enrolled participants, 47 (44.8%) had obesity (BMI 30.0 or higher) and 29 (27.6%) were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112-196 mL). Eighty-nine (84.8%) had at least one evaluable follow-up evaluation. Participants had median (interquartile range) absolute blood-loss decreases at cycles 3 (n=86) and 6 (n=81) of 93.3% (86.1-97.7%) and 97.6% (90.4-100%), respectively. At cycle 6, participants without obesity (n=43) and with obesity (n=38) had similar median [interquartile range] decreases (97.6% [91.8-100%] and 97.5% [90.3-100%], respectively; P =.89), with comparable findings for nulliparous (n=25) and parous (n=56) participants (97.0% [91.7-99.1%] and 98.1% [89.9-100%], respectively; P =.43). Treatment success occurred in 81.8% (95% CI 74.2-89.4%) of 99 participants, excluding those with no outcomes due to lost to follow-up or consent withdrawal, and did not vary by BMI or parity. The most common adverse events leading to discontinuation were bleeding or cramping (n=6 [5.7%]) and expulsion (n=5 [4.8%]).ConclusionThis levonorgestrel 52-mg IUD reduces blood loss by more than 90% over 6 months compared with baseline for most users with heavy menstrual bleeding.Funding sourceMedicines360.Clinical trial registrationClinicalTrials.gov , NCT03642210.
| S-EPMC10108838 | biostudies-literature
Project description:ObjectiveThe objective was to describe the sonographic position of copper intrauterine devices (IUDs) 6 months after insertion during cesarean delivery.Study designThis 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.ResultsSixty-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%).ConclusionAlthough 59% of copper IUDs placed during cesarean were correctly positioned at 6 months, nearly one third were malpositioned.ImplicationsUltrasound 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.
| S-EPMC7644571 | biostudies-literature