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Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.

ABSTRACT: BACKGROUND:Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. METHODS:This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. DISCUSSION:A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. TRIAL REGISTRATION:Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.

SUBMITTER: Harrison MS

PROVIDER: S-EPMC6869182 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.

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

Trials 20191121 1

<h4>Background</h4>Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.<h4>Methods</h4>This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the n ...[more]

PMID: 31752969

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Project description:BackgroundProvision of family planning services during the immediate post-partum phase is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception. Moreover, it will also test the non-inferiority of text and voice messages compared to interactive phone-based counselling.MethodsA three-arm, 10-month, multicentre, randomized controlled trial will be conducted at 15 social franchise (SF) health facilities in Punjab province of Pakistan. Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study. The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support). The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan. It will broadly cover birth-preparedness, importance of birth spacing, and postnatal care. The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods. Risk differences will be used as the measure of effect of the intervention on the outcomes.DiscussionThe study findings will highlight effectiveness of mobile phone in raising awareness of maternal health and contraception, which in turn, is expected to be translated into increased proportion of: at least four antenatal visits, skilled birth or institutional delivery, postpartum contraceptive use, postnatal check-up, child immunization, and breastfeeding. Moreover, if the text and voice messages approach is proven to be non-inferior to interactive calls, it will provide evidence to making promotion of healthcare less resource intensive, and thereby contribute in improving the efficiency of the healthcare system.Trial registrationThis trial was prospectively registered with the Clinical Trials registry ( NCT03612518 ) on August 2nd, 2018.

Project description: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 <?0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p <?0.001. Implant use by 3?months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p <?0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION:Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3?months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION:clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

Project description:BackgroundOpioid use disorder (OUD) among women delivering at a hospital has increased 400% from 1999-2014 in the United States. From the years 2007 to 2016, opioid-related mortality during pregnancy increased over 200%, and drug-overdose deaths made up nearly 10% of all pregnancy-associated mortality in 2016 in the US. Disproportionately higher rates of neonatal opioid withdrawal syndrome (NOWS) have been reported in rural areas of the country, suggesting that perinatal OUD is a pressing issue among these communities. There is an urgent need for comprehensive, evidence-based treatment services for pregnant women experiencing OUD. The purpose of this article is to describe a study protocol aimed at developing and evaluating a perinatal OUD curriculum, enhancing evidence-based perinatal OUD treatment in a rural setting, and evaluating the implementation of such collaborative care for perinatal OUD.MethodsThis two-year study employed a one group, repeated measures, hybrid type-1 effectiveness-implementation design. This study delivered interventions at 2 levels, both targeting improvement of care for pregnant women with OUD. The first area of focus was at the community healthcare provider-level, which aimed to evaluate the acceptability and feasibility of perinatal OUD education across time and to improve provider education by increasing knowledge specific to: MOUD provision; screening, brief intervention, and referral to treatment (SBIRT) utilization; and NOWS treatment. The second area of intervention focus was at the patient-level, which assessed the preliminary effect of perinatal OUD provider education in promoting illicit opioid abstinence and treatment engagement among pregnant women with OUD. We adopted constructs from the Consolidated Framework for Implementation Research (CFIR) to assess contextual factors that may influence implementation, and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model to comprehensively evaluate implementation outcomes.DiscussionThis article presents the protocol of an implementation study that is employing the CFIR and RE-AIM frameworks to implement and evaluate a perinatal OUD education and service coordination program in two rural counties. This protocol could serve as a model for clinicians and researchers seeking to implement improvements in perinatal care for women with OUD in other rural communities. Trial registration NCT04448015 clinicaltrials.gov.

Project description:BACKGROUND:About half of births in rural Tanzania are assisted by skilled providers. Point-of-care mobile phone applications hold promise in boosting job support for community health workers aiming to ensure safe motherhood through increased facility delivery awareness, access and uptake. We conducted a controlled comparison to evaluate a smartphone-based application designed to assist community health workers with data collection, education delivery, gestational danger sign identification, and referrals. METHODS:Community health workers in 32 randomly selected villages were cluster-randomized to training on either smartphone (intervention) or paper-based (control) protocols for use during household visits with pregnant women. The primary outcome measure was postnatal report of delivery location by 572 women randomly selected to participate in a survey conducted by home visit. A mixed-effects model was used to account for clustering of subjects and other measured factors influencing facility delivery. FINDINGS:The smartphone intervention was associated with significantly higher facility delivery: 74% of mothers in intervention areas delivered at or in transit to a health facility, versus 63% in control areas. The odds of facility delivery among women counseled by smartphone-assisted health workers were double the odds among women living in control villages (OR, 1.96; CI, 1.21-3.19; adjusted analyses). Women in intervention areas were more likely to receive two or more visits from a community health worker during pregnancy than women in the control group (72% vs. 60%; chi-square = 6.9; p < 0.01). Previous facility delivery, uptake of antenatal care, and distance to the nearest facility were also strong independent predictors of facility delivery. INTERPRETATION:Community health worker use of smartphones increased facility delivery, likely through increased frequency of prenatal home visits. Smartphone-based job aids may enhance community health worker support and effectiveness as one component of intervention packages targeting safe motherhood. TRIAL REGISTRATION:NCT03161184.

Project description:ObjectivesTo compare receipt of contraception and method effectiveness in the early postpartum period among women with and without a recent preterm birth (PTB).MethodsWe used data from North Carolina birth certificates linked to Medicaid claims. We assessed contraceptive claims with dates of service within 90 days of delivery among a retrospective cohort of women who had a live birth covered by Medicaid between September 2011 and 2012 (n = 58,201). To estimate the odds of receipt of contraception by PTB status (24-36 weeks compared to 37-42 weeks [referent]), we used logistic regression and tested for interaction by parity. To estimate the relationship between PTB and method effectiveness based on the Center for Disease Control and Prevention Levels of Effectiveness of Family Planning Methods (most, moderate and least effective [referent]), we used multinomial logistic regression.ResultsLess than half of all women with a live birth covered by Medicaid in North Carolina had a contraceptive claim within 90 days postpartum. Women with a recent PTB had a lower prevalence of contraceptive receipt compared to women with a term birth (45.7% vs. 49.6%). Women who experienced a PTB had a lower odds of receiving contraception. When we stratified by parity, women with a PTB had a lower odds of contraceptive receipt among women with more than two births (0.79, 95% CI 0.74-0.85), but not among women with two births or fewer. One-fourth of women received a most effective method. Women with a preterm birth had a lower odds of receiving a most effective method (0.83, 95% CI 0.77-0.88) compared to women with a term birth.Conclusions for practiceContraceptive receipt was low among women with a live birth covered by Medicaid in North Carolina. To optimize contraceptive use among women at risk for subsequent preterm birth, family planning strategies that are responsive to women's priorities and context, including a history of preterm birth, are needed.SignificanceAccess to free or affordable highly effective contraception is associated with reductions in preterm birth. Self-report data indicate that women with a very preterm birth (PTB) are less likely to use highly or moderately effective contraception postpartum compared to women delivering at later gestational ages. Using Medicaid claims data, we found that less than half of all women with a Medicaid covered delivery in North Carolina in 2011-2012 had a contraceptive claim within 90 days postpartum, and one fourth received a most effective method. Women with a PTB and more than two children were least likely to receive any method. Family planning strategies that are responsive to women's priorities and context, including a history of preterm birth, are needed so that women may access their contraceptive method of choice in the postpartum period.

Dataset Information

Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.

Publications

Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.

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