Evidence map›Paper›PMID 32819394›Full record

Trial reportReproductive health2020

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

Margo S Harrison, Saskia Bunge-Montes, Claudia Rivera, Andrea Jimenez-Zambrano, Gretchen Heinrichs, Antonio Bolanos, Edwin Asturias, Stephen Berman, Jeanelle Sheeder

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Reproductive health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04005391 (Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04005391 nacompletednot on this map

Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial

TypeinterventionalSponsorUniversity of Colorado, DenverRan2018 to 2020Enrolled208ConditionsPostpartumArmsOffer of Participant's Choice of Contraception Method
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Margo S HarrisonUniversity of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA. margo.harrison@cuanschutz.edu.ORCID http://orcid.org/0000-0003-2940-2241
Saskia Bunge-MontesFundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.
Claudia RiveraFundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.
Andrea Jimenez-ZambranoUniversity of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.
Gretchen HeinrichsDenver Health, Denver, CO, USA.
Antonio BolanosFundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.
Edwin AsturiasUniversity of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.
Stephen BermanUniversity of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.
Jeanelle SheederUniversity of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.
University of Colorado Anschutz Medical Campus · USCenter for the Study of Equity and Governance in Health Systems · GTDenver Health Medical Center · US

Funding

COLORADO WRHR CAREER DEVELOPMENT CENTERK12HD001271 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Saketh R Guntupalli · 1999 to 2026
$8.9M
NICHD NIH HHS K12 HD001271
6 · The paper itself

Abstract

designThis 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.

methodsIn 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.

resultsOnce 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].

conclusionOur 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 registrationclinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

Indexed as

Contraception BehaviorHealth Services AccessibilityPostpartum PeriodAdultContraceptionContraceptive AgentsCounselingFamily Planning ServicesFemaleGuatemalaHumansOutcome and Process Assessment, Health CarePregnancyYoung AdultContraceptive AgentsGuatemalaImplantPostpartum contraception

Identifiers

PMID32819394
PMCPMC7439552
OpenAlexW3049818307

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.