Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women
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|ClinicalTrials.gov Identifier: NCT04005391|
Recruitment Status : Completed
First Posted : July 2, 2019
Results First Posted : November 24, 2020
Last Update Posted : July 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum||Other: Offer of Participant's Choice of Contraception Method||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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).|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial|
|Actual Study Start Date :||October 23, 2018|
|Actual Primary Completion Date :||February 19, 2020|
|Actual Study Completion Date :||November 19, 2020|
Experimental: Postpartum Contraceptives offered to Intervention Clusters
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
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
No Intervention: Routine Care offered to Control Clusters
Women will receive routine postpartum care
- Number of Participants With Implant Use at Three Months [ Time Frame: Three months ]
- Number of Participants With Any Contraceptive Use at Three Months [ Time Frame: 3 Months ]Participants actively using any contraceptive method three months after enrollment in the study as assessed by the three-month survey
- Contraceptive Satisfaction at Twelve Months [ Time Frame: 12 Months ]Participant satisfaction with any contraceptive method the woman might be using as determined by a survey question that asks if the woman is very satisfied, satisfied, dissatisfied, or very dissatisfied.
- Number of Participants With Contraceptive Continuation at Twelve Months [ Time Frame: 12 Months ]Continuation of any contraceptive method a woman started in the postpartum period assessed by a survey at three and twelve months after study enrollment
- Number of Participants With Repeat Pregnancy at Twelve Months [ Time Frame: 12 Months ]Repeat pregnancy after enrollment in the study, as assessed at the enrollment (baseline) visit and at three and twelve months after study enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005391
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|Fundacion para la Salud Integral de los Guatemaltecos|
|Caballo Blanco, Ritalhuleu, Guatemala|
|Principal Investigator:||Margo S Harrison, MD, MPH||University of Colorado, Denver|