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Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

ABSTRACT: BACKGROUND:Use of long-acting, highly effective contraception has the potential to improve women's ability to avoid short interpregnancy intervals, which are associated with an increased risk of maternal morbidity and mortality, and preterm delivery. In Uganda, contraceptive implants are not routinely available during the immediate postpartum period. OBJECTIVE:The purpose of this study was to compare the proportion of women using levonorgestrel contraceptive implants at 6 months after delivery in women randomized to immediate or delayed insertion. STUDY DESIGN:This was a randomized controlled trial among women in Kampala, Uganda. Women who desired contraceptive implants were randomly assigned to insertion of a 2-rod contraceptive implant system containing 75 mg of levonorgestrel immediately following delivery (within 5 days of delivery and before discharge from the hospital) or delayed insertion (6 weeks postpartum). The primary outcome was implant utilization at 6 months postpartum. RESULTS:From June to October 2015, 205 women were randomized, 103 to the immediate group and 102 to the delayed group. Ninety-three percent completed the 6 month follow-up visit. At 6 months, implant use was higher in the immediate group compared with the delayed group (97% vs 68%; P < .001), as was the use of any highly effective contraceptive (98% vs 81%; P = .001). Women in the immediate group were more satisfied with the timing of implant placement. If given the choice, 81% of women in the immediate group and 63% of women in the delayed group would choose the same timing of placement again (P = .01). There were no serious adverse events in either group. CONCLUSION:Offering women the option of initiating contraceptive implants in the immediate postpartum period has the potential to increase contraceptive utilization, decrease unwanted pregnancies, prevent short interpregnancy intervals, and help women achieve their reproductive goals.

SUBMITTER: Averbach S

PROVIDER: S-EPMC6310612 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

Averbach Sarah S Kakaire Othman O Kayiga Herbert H Lester Felicia F Sokoloff Abby A Byamugisha Josaphat J Dehlendorf Christine C Steinauer Jody J

American journal of obstetrics and gynecology 20170610 5

<h4>Background</h4>Use of long-acting, highly effective contraception has the potential to improve women's ability to avoid short interpregnancy intervals, which are associated with an increased risk of maternal morbidity and mortality, and preterm delivery. In Uganda, contraceptive implants are not routinely available during the immediate postpartum period.<h4>Objective</h4>The purpose of this study was to compare the proportion of women using levonorgestrel contraceptive implants at 6 months a ...[more]

PMID: 28610898

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Project description:ObjectiveThis study assessed whether immediate postpartum insertion of levonorgestrel contraceptive implants is associated with a difference in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 and 6 months postpartum compared to delayed insertion at 6 to 8 weeks postpartum.Study designWe conducted a randomized trial of women in Uganda who desired contraceptive implants postpartum. We randomly assigned participants to receive either immediate (within 5 days of delivery) or delayed (6 to 8 weeks postpartum) insertion of a two-rod levonorgestrel contraceptive implant system. This is a prespecified secondary analysis evaluating breastfeeding outcomes. The primary outcome of this secondary analysis was change in infant weight; infants were weighed and measured at birth and 6 months. We used a validated questionnaire to assess onset of lactogenesis daily in person while participants were in the hospital, and then daily by phone after they left the hospital, until lactogenesis was documented. We used interviewer-administered questionnaires to assess breastfeeding continuation and concerns at 3 months and 6 months postpartum.ResultsAmong the 96 women randomized to the immediate group and the 87 women to the delayed group, the mean change in infant weight from birth to 6 months was similar between groups: 4632 g in the immediate group and 4407 g in the delayed group (p=.26). Among the 97 women who had not experienced lactogenesis prior to randomization, the median time to onset of lactogenesis did not differ significantly between the immediate and delayed groups (65 h versus 63 h; p=.84). Similar proportions of women in the immediate and delayed groups reported exclusive breastfeeding at 3 months (74% versus 71%; p=.74) and 6 months (48% versus 52%; p=.58).ConclusionWe found no association between the timing of postpartum initiation of levonorgestrel contraceptive implants and change in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 or 6 months postpartum.ImplicationsThis study provides evidence that immediate postpartum initiation of contraception implants does not have a deleterious effect on infant growth or initiation or continuation of breastfeeding.

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:ImportanceFacilitating access to the full range of contraceptive options is a health policy goal; however, inpatient provision of postpartum long-acting reversible contraceptive (LARC) methods has been limited due to lack of hospital reimbursement. Between March 2014 and January 2015, the Medicaid programs in 5 states began to reimburse hospitals for immediate postpartum LARC separately from the global maternity payment.ObjectiveTo examine the association between Medicaid policies and provision of immediate postpartum LARC, and to examine hospital characteristics associated with policy adoption.Design, setting, and participantsThis cross-sectional study used interrupted time series analysis. The setting was population-based in Georgia, Iowa, Maryland, New York, and Rhode Island. Participants included individuals who gave birth in these states between 2011 and 2017 (n = 3 097 188). Statistical analysis was performed from June 2021 to August 2022.ExposuresChildbirth after the start of Medicaid's reimbursement policy.Main outcomes and measuresImmediate postpartum LARC (outcome), teaching hospital, Catholic-owned or operated, obstetrical care level, and urban or rural location (hospital characteristics).ResultsThe study included a total of 1 521 491 births paid for by Medicaid and 1 575 697 paid for by a commercial payer between 2011 and 2017. Prior to Medicaid reimbursement changes, 489 389 of 726 805 births (67%) were to individuals between 18 and 29 years of age, 219 363 of 715 905 births (31%) were to non-Hispanic Black individuals, 227 639 of 715 905 births (32%) were to non-Hispanic White individuals, 155 298 of 715 905 births (22%) were to Hispanic individuals, and 113 605 of 715 905 births (16%) were to individuals from other non-Hispanic racial groups. Among Medicaid-paid births, the policies were associated with an increase in the rate of immediate postpartum LARC provision in all states, although results for Maryland were not consistent across sensitivity analyses. The change in trend ranged from a quarterly increase of 0.05 percentage points in Maryland (95% CI, 0.01-0.08 percentage points) and 0.05 percentage points in Iowa (95% CI, 0.00-0.11 percentage points) to 0.82 percentage points (95% CI, 0.73-0.91 percentage points) in Rhode Island. The policy was also associated with an increase in immediate postpartum LARC provision among commercially paid births in 4 of 5 states. After the policy, only 38 of 366 hospitals (10%) provided more than 1% of birthing people with immediate postpartum LARC. These adopting hospitals were less likely to be Catholic (0% [0 of 31] vs 17% [41 of 245]), less likely to be rural (10% [3 of 31] vs 33% [81 of 247]), more likely to have the highest level of obstetric care (71% [22 of 31] vs 29% [65 of 223]) and be teaching hospitals (87% [27 of 31] vs 43% [106 of 246]) compared with nonadopting hospitals.Conclusions and relevanceThis cross-sectional study's findings suggest that Medicaid policies that reimburse immediate postpartum LARC may increase access to this service; however, policy implementation has been uneven, resulting in unequal access.

Project description:BackgroundUnwanted pregnancies remain a burden for women living with HIV (WLWH). Family planning prevents unplanned pregnancies while promoting longer birth intervals, key strategies to eliminate perinatal transmission of HIV and promote maternal and child health. We evaluated the effect of a family planning voucher, inclusive of immediate postpartum counseling, on uptake, early initiation, and continuation of modern contraceptive methods among recently postpartum WLWH delivering at a publicly funded regional referral hospital in rural, southwestern Uganda.Methods and findingsWe performed a randomized controlled trial between October, 2016 and June, 2018 at a referral hospital in southwestern Uganda. This interim analysis includes adult WLWH randomized and enrolled equally to receive a family planning voucher or standard of care (control). Enrolled postpartum WLWH completed an interviewer-administered questionnaire at enrollment and 6 months postpartum. Our primary outcome of interest for this analysis is initiation of a modern family planning method within 8 weeks postpartum. Secondary outcomes included family planning initiation at 12, 14, 16, and 20 weeks postpartum, family planning discontinuation and/or change, pregnancy incidence, and mean time without contraception. The trial was registered with clinicaltrials.gov (NCT02964169). At enrollment, half of the women in both the voucher (N = 87, 55%) and control (N = 86, 54%) groups wanted to have a child in 2 years postpartum. Over 80% of referent pregnancies in the voucher (N = 136, 86%) and control (N = 128, 81%) groups were planned. All women were accessing ART. The mean CD4 count was 396 cells/mm3 (SD = 61) for those enrolled in the control group versus 393 cells/mm3 (SD = 64) in the family planning voucher group. By 8 weeks postpartum, family planning was initiated in 144 (91%) participants in the voucher group and 83 (52%) participants in the control group (odds ratio [OR] 9.42; CI 4.67-13.97, P < 0.001). We also found high family planning uptake rates for both groups, with higher rates among the intervention group at 12 weeks (OR 5.66; CI 2.65-12.12, P < 0.001), 14 weeks (OR 2.51; CI 1.31-4.79, P < 0.001), 16 weeks (OR 4.02; CI 1.66-9.77, P = 0.001), and 20 weeks (OR 3.65; CI 1.40-9.47, P = 0.004) postpartum. The average time to family planning initiation was reduced to 5.9 weeks (SD = 2.4) for those in the voucher group compared to 9.3 weeks (SD = 5) in the control (P < 0.001). One pregnancy was recorded in the group receiving standard of care; none were reported in the voucher group. Method mix did not differ by group: injectables were selected by most women (N = 150, 50%), and 52% of this proportion were in the experimental arm, with <10% in each arm selecting condoms, oral contraception, or intrauterine devices (IUDs). Similar proportions of women changed contraceptive methods over the 6-month follow-up in the voucher and control groups (N = 8, 5% versus N = 5, 4%; P = 0.467). More women in the control group discontinued contraception for 1 to 2 weeks (N = 19, 13% versus N = 7, 5%; P = 0.008) or more than 4 weeks (N = 15, 10% versus N = 3, 2%; P = 0.002) compared to those given a family planning voucher. The main limitation of this study is that its findings may not be generalized to settings without improved availability of contraceptives in publicly funded facilities.ConclusionThese findings indicate that a well-structured, time-bound family planning voucher program appeared to increase early postpartum contraceptive uptake and continuation in a setting in which users are faced with financial, knowledge, and structural barriers to contraceptive services. Further work should clarify the role of vouchers in empowering WLWH to avoid unintended pregnancies over time.Trial registrationClinicalTrials.gov NCT02964169.

Project description:ObjectiveTo evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR).Study designNon-inferiority randomised controlled trial.PopulationWomen undergoing laparoscopic hysterectomy in six hospitals in the Netherlands.MethodsWomen were randomised to ICR or DCR (between 18 and 24 hours after surgery).Primary outcomeThe inability to void within 6 hours after catheter removal.ResultsOne hundred and fifty-five women were randomised to ICR (n = 74) and DCR (n = 81). The intention-to-treat and per-protocol analysis could not demonstrate the non-inferiority of ICR: ten women with ICR could not urinate spontaneously within 6 hours compared with none in the delayed group (risk difference 13.5%, 5.6-24.8, P = 0.88). However, seven of these women could void spontaneously within 9 hours without additional intervention. Regarding the secondary outcomes, eight women from the delayed group requested earlier catheter removal because of complaints (9.9%). Three women with ICR (4.1%) had a urinary tract infection postoperatively versus eight with DCR (9.9%, risk difference -5.8%, -15.1 to 3.5, P = 0.215). Women with ICR mobilised significantly earlier (5.7 hours, 0.8-23.3 versus 21.0 hours, 1.4-29.9; P ≤ 0.001).ConclusionThe non-inferiority of ICR could not be demonstrated in terms of urinary retention 6 hours after procedure. However, 70% of the women with voiding difficulties could void spontaneously within 9 hours after laparoscopic hysterectomy. It is therefore questionable if all observed urinary retention cases were clinically relevant. As a result, the clinical advantages of ICR may still outweigh the risk of bladder retention and it should therefore be considered after uncomplicated laparoscopic hysterectomy.Tweetable abstractThe advantages of immediate catheter removal after laparoscopic hysterectomy seem to outweigh the risk of bladder retention.

Project description:IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

Dataset Information

Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

Publications

Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

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