MedDataX Logo

Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya

NCT ID: NCT02104635

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal and Newborn Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

The control group receives standard of care from Jacaranda clinic and does not receive any additional post-partum check-in from a community health worker.

Group Type NO_INTERVENTION

No interventions assigned to this group

CHW-Visit

The CHW-Visit group will receive a visit at their home from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check.

Group Type EXPERIMENTAL

Delivery of a Post-Partum Package

Intervention Type BEHAVIORAL

CHW-Phone

The CHW-Visit group will receive a phone call from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check.

Group Type EXPERIMENTAL

Delivery of a Post-Partum Package

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Delivery of a Post-Partum Package

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Women between 18 and 40 years old are eligible for inclusion if they have had a safe normal delivery of a live infant delivery at a Jacaranda Health facility. Eligible women must reside in a 20 km radius from the Jacaranda Health's hospital facility in peri-urban Nairobi. Women must provide a phone number to where they expect that can be reached 2 weeks postpartum.

Exclusion Criteria

Women who elect to leave the Jacaranda Health facility before the recommended 24 hours, against medical advice, postpartum are not eligible to participate in the postpartum care study. Women and their newborns who are referred to another hospital for higher level emergency obstetric or neonatal care will not be eligible to participate. Women who relocate outside the defined geographic area surrounding the hospital after their delivery are also not eligible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jessica Cohen, Harvard School of Public Health

UNKNOWN

Sponsor Role collaborator

Saving Lives at Birth Initiative

UNKNOWN

Sponsor Role collaborator

Jacaranda Health

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaret McConnell

Assistant Professor of Global Health Economics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jacaranda Health

Nairobi, , Kenya

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kenya

References

Explore related publications, articles, or registry entries linked to this study.

McConnell M, Ettenger A, Rothschild CW, Muigai F, Cohen J. Can a community health worker administered postnatal checklist increase health-seeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya. BMC Pregnancy Childbirth. 2016 Jun 4;16(1):136. doi: 10.1186/s12884-016-0914-z.

Reference Type DERIVED
PMID: 27260500 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Saving Lives at Birth

Identifier Type: -

Identifier Source: org_study_id