Dataset Information

Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

ABSTRACT: DESIGN:This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3?months post-enrollment. METHODS:In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS:Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p

SUBMITTER: Harrison MS

PROVIDER: S-EPMC7439552 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

Harrison Margo S MS Bunge-Montes Saskia S Rivera Claudia C Jimenez-Zambrano Andrea A Heinrichs Gretchen G Bolanos Antonio A Asturias Edwin E Berman Stephen S Sheeder Jeanelle J

Reproductive health 20200820 1

<h4>Design</h4>This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment.<h4>Methods</h4>In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and ra ...[more]

PMID: 32819394

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Project description:Vertical global health programmes often evaluate success with a narrow focus on programmatic outcomes. However, evaluation of broader patient-centred and unintended outcomes is critical to assess impacts on patient choice and autonomy. Here, we evaluate the effects of a postpartum intrauterine device (PPIUD) intervention on outcomes related to contraceptive method choice. The stepped-wedge cluster randomized contolled trial (RCT) took place in five Tanzanian hospitals. Hospitals were randomized to receive immediate (Group 1; n = 11 483 participants) or delayed (Group 2; n = 8148 participants) intervention. The intervention trained providers on PPIUD insertion and counselling. The evaluation surveyed eligible women (18+, resided in Tanzania, gave birth at a study hospital) on provider postpartum contraceptive counselling during pregnancy or immediately postpartum. In our completed study, participants were considered exposed (n = 9786) or unexposed (n = 10 145) to the intervention based on the location and timing of their birth (no blinding). Our secondary analysis examined differences by intervention exposure on the likelihood of being counselled on IUD only, multiple methods, multiple method durations, a broad method mix; and on the number of methods women were counselled across two samples: all eligible women, and only women who reported receiving any contraceptive counselling. Among all eligible women, counselling on the IUD alone was 7% points higher among the exposed (95% confidence interal (CI): 0.02, 0.12). Among women who received any counselling, those exposed to the intervention were counselled on 1.12 fewer contraceptive methods (95% CI: 0.10, 2.34). The likelihood of receiving counselling on any non-IUD method decreased among those exposed, while the likelihood of being counselled on an IUD alone was 14% points higher among the exposed (95% CI: 0.06, 0.22), suggesting this intervention increased IUD-specific counselling but reduced informed contraceptive choice. These findings underscore the importance of broad metrics that capture autonomy and rights (in addition to programmatic goals) at all stages of health programme planning and implementation.

Project description:ImportanceNineteen states have passed legislation requiring insurers to cover the dispensation of a 12-month supply of short-acting, hormonal contraception.ObjectiveTo determine whether 12-month contraceptive supply policies were associated with an increase in the receipt of 12-month or longer supply of contraception.Design, setting, and participantsThis retrospective cohort study included data from all female Medicaid enrollees aged 18 to 44 years who used short-acting hormonal contraception (ie, pill, patch, or ring) from 2016 to 2020.ExposuresEleven treatment states where legislation required insurers to cover a 12-month supply of contraception to continuing users and 25 comparison states without such legislation prior to December 2020.Main outcomes and measuresProportion of contraception months received via a single 12-month or longer fill.ResultsThis study included 48 255 512 months of dispensed oral pill, patch, and ring contraception prescription supply among 4 778 264 female Medicaid enrollees. The majority of months of supplied contraception were for the contraceptive pill rather than the patch or ring. In a staggered difference-in-differences model, the 12-month supply policy was associated with an estimated 4.39-percentage point (pp) increase (95% CI, 4.38 pp-4.40 pp) in the proportion of contraception dispensed as part of a 12-month or longer supply, from a mean of 0.11% in treatment states during the first quarter of the study period. Investigating the heterogeneity in policy association across states, California stood out with a 7.17-pp increase (95% CI, 7.15 pp-7.19 pp) in the proportion of contraception dispensed as a 12-month or longer supply; in the other 10 treatment states, the policy association was less than 1 pp.Conclusions and relevanceIn this cohort study of Medicaid recipients using short-acting hormonal contraception, the passage of a 12-month contraceptive supply policy was associated with a minimal increase in the proportion of contraception dispensed through a 12-month or longer supply.

Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Dataset Information

Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

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Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

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