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 vehicle. 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 three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place 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. Retrospective Trial Registration clinicaltrials.gov Trial Identifying Number NCT04005391 Date of Registration in Primary Registry: July 1, 2019 Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04005391?term=NCT04005391&rank=1 Keywords: postpartum contraception, long-acting reversible contraceptives, implant, nursing, community programming, cluster-randomized trial

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

“…Trial Design: Our study, the protocol of which has been published, was a cluster-randomized, pragmatic, parallel arm trial. 6 The rationale for using a cluster design was that the region is already historically divided into twelve communities that define themselves by their cultural identity. Nurses are assigned to communities and provide care to women through that organizational structure, and as such, it would likely have been less successful to divide the region into clusters through another mechanism, and an individual-randomized design would not have respected the correlation that exists within these communities.…”

“…The twelve communities in the Southwest Trifinio were combined into eight clusters based on data from births by community in 2017. 6 The clusters combined communities already served by the Madres Sanas nurse teams with around twenty-five expected births (postpartum visits) per cluster over the year of projected study enrollment. 6 Clusters were then randomized to intervention or control status, within each nurse team.…”

“…6 The clusters combined communities already served by the Madres Sanas nurse teams with around twenty-five expected births (postpartum visits) per cluster over the year of projected study enrollment. 6 Clusters were then randomized to intervention or control status, within each nurse team. 6 There were no changes to these methods after trial commencement.…”

“…6 Clusters were then randomized to intervention or control status, within each nurse team. 6 There were no changes to these methods after trial commencement. Location of the communities in a map of the region can be founded in the published trial protocol.…”

“…5 Our study, the protocol of which has been published, was a cluster-randomized, pragmatic, parallel arm trial whereby women in intervention clusters had experienced study nurses bring contraceptives (condoms, pills, injection, implant) to postpartum mothers' in their homes. 6 The objective of the study was to observe if the reduced access barrier by providing contraceptives at the final home visit was associated with an increase in implant uptake by three months postpartum. The objective and hypothesis pertain to the individual participant level.…”