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N/A N=208 Randomized Health Services Research

Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women

Postpartum

Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Implant Use at Three Months — 28; 2 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Offer of Participant's Choice of Contraception Method (Other)
Age
Pediatric, Adult · 15+ yrs
Sex
Female
Sponsor
University of Colorado, Denver
Primary completion
Feb 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Implant Use at Three Months
28; 2
SECONDARY
Number of Participants With Any Contraceptive Use at Three Months
83; 56
SECONDARY
Contraceptive Satisfaction at Twelve Months
68; 57; 26; 34
SECONDARY
Number of Participants With Contraceptive Continuation at Twelve Months
73; 59
SECONDARY
Number of Participants With Repeat Pregnancy at Twelve Months
0; 4

Summary

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. The study removes some access barriers (distance, time, cost) by providing contraception in the home. The community nurses were trained 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, the 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.

Eligibility Criteria

Inclusion Criteria

  • postpartum state
  • enrolled in the Madres Sanas program
  • able and willing to consent
  • meeting age criteria
  • not already received a contraceptive method

Exclusion Criteria

  • unable or unwilling to provide informed consent
  • does not meet age criteria
  • has already used a contraceptive method
  • is pregnant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04005391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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