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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
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

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.


Condition or disease Intervention/treatment Phase
Postpartum Other: Offer of Participant's Choice of Contraception Method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • condoms
  • contraceptive pills
  • medroxyprogesterone acetate injection
  • levonorgestrel implant

No Intervention: Routine Care offered to Control Clusters
Women will receive routine postpartum care



Primary Outcome Measures :
  1. Number of Participants With Implant Use at Three Months [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postpartum state, which can only occur in females
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Guatemala
Fundacion para la Salud Integral de los Guatemaltecos
Caballo Blanco, Ritalhuleu, Guatemala
Sponsors and Collaborators
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Margo S Harrison, MD, MPH University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04005391    
Other Study ID Numbers: 17-1314
5K12HD001271 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2019    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
postpartum contraception
long-acting reversible contraceptives
implant
nursing
community programming
cluster-randomized trial
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Contraceptive Agents
Levonorgestrel
Medroxyprogesterone
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents