N/A
N=208
Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women
Postpartum
Bottom Line
View on ClinicalTrials.gov: NCT04005391 ↗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
| Outcome | Result | p-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
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.