NCT04005391

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
5 days until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 26, 2019

Results QC Date

May 18, 2020

Last Update Submit

June 10, 2021

Conditions

Postpartum

Keywords

postpartum contraceptionlong-acting reversible contraceptivesimplantnursingcommunity programmingcluster-randomized trial

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Implant Use at Three Months

    Three months

Secondary Outcomes (4)

  • Number of Participants With Any Contraceptive Use at Three Months

    3 Months

  • Contraceptive Satisfaction at Twelve Months

    12 Months

  • Number of Participants With Contraceptive Continuation at Twelve Months

    12 Months

  • Number of Participants With Repeat Pregnancy at Twelve Months

    12 Months

Study Arms (2)

Postpartum Contraceptives offered to Intervention Clusters

EXPERIMENTAL

Women will have postpartum contraceptive options (condoms "vive amor", birth control pills "segura plus", injectable "cyclofem", contraceptive implant "jadelle") offered to them at their routine forty day postpartum visit after routine care is provided, first.

Other: Offer of Participant's Choice of Contraception Method

Routine Care offered to Control Clusters

NO INTERVENTION

Women will receive routine postpartum care

Interventions

Offer of Participant's Choice of Contraception MethodOTHER

Women will be offered a range of contraceptive options (condoms, contraceptive pills, medroxyprogesterone acetate injection, levonorgestrel implant) to choose from; they can decline to start a contraceptive method

Also known as: condoms, contraceptive pills, medroxyprogesterone acetate injection, levonorgestrel implant
Postpartum Contraceptives offered to Intervention Clusters

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum state, which can only occur in females
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • unable or unwilling to provide informed consent
  • does not meet age criteria
  • has already used a contraceptive method
  • is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Fundacion para la Salud Integral de los Guatemaltecos

Caballo Blanco, Ritalhuleu, Guatemala

Location

Related Publications (3)

  • Harrison MS, Bunge-Montes S, Rivera C, Jimenez-Zambrano A, Heinrichs G, Bolanos A, Asturias E, Berman S, Sheeder J. Initial Contraceptive Choices of Women Enrolled in a Cluster-Randomized Trial in Southwest Trifinio, Guatemala. Matern Child Health J. 2022 Jan;26(1):168-176. doi: 10.1007/s10995-021-03275-4. Epub 2021 Oct 28.

    PMID: 34709526DERIVED

  • Harrison MS, Bunge-Montes S, Rivera C, Jimenez-Zambrano A, Heinrichs G, Bolanos A, Asturias E, Berman S, Sheeder J. Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala. Reprod Health. 2020 Aug 20;17(1):127. doi: 10.1186/s12978-020-00974-z.

    PMID: 32819394DERIVED

  • Harrison MS, Bunge-Montes S, Rivera C, Jimenez-Zambrano A, Heinrichs G, Scarbro S, Juarez-Colunga E, Bolanos A, Asturias E, Berman S, Sheeder J. Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol. Trials. 2019 Nov 21;20(1):639. doi: 10.1186/s13063-019-3735-3.

    PMID: 31752969DERIVED

MeSH Terms

Interventions

CondomsMedroxyprogesterone AcetateLevonorgestrel

Intervention Hierarchy (Ancestors)

Contraceptive Devices, MaleContraceptive DevicesEquipment and SuppliesMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesNorpregnanesNorsteroids

Results Point of Contact

Title
Margo Harrison
Organization
University of Colorado
margo.harrison@cuanschutz.edu
19176555178

Study Officials

  • Margo S Harrison, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Superiority trial to see if home-based postpartum contraceptive delivery, including a long-acting reversible contraceptive, the contraceptive implant, increases uptake of a highly effective method of postpartum contraception (the implant).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 2, 2019

Study Start

October 23, 2018

Primary Completion

February 19, 2020

Study Completion

November 19, 2020

Last Updated

July 2, 2021

Results First Posted

November 24, 2020

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)GU(1)