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

December 1, 2014 updated by: Margaret McConnell, Harvard School of Public Health (HSPH)
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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nairobi, Kenya
        • Jacaranda Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications detected
Time Frame: 3 days after delivery
Any maternal complications detected Number of maternal complications detected Any newborn complications detected Number of newborn complications detected
3 days after delivery
Successful referrals
Time Frame: 10 days after delivery (survey and administrative records)
If CHW made referral on day 3 for baby, respondent went to health facility If CHW made referral on day 3 for mother, respondent went to health facility
10 days after delivery (survey and administrative records)
Care Seeking Behavior around complications and well baby check-up
Time Frame: 10 days after delivery (survey)
Brought baby to health facility for a well-baby check up If maternal complications (self-reported) in past week, visited or called health facility If baby complications (self-reported) in past week, visited or called health facility
10 days after delivery (survey)
Knowledge of danger signs
Time Frame: 10 days after delivery (survey)
Can name any maternal danger signs for which care should be sought (at day 10) Number of maternal danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not Can name any baby danger signs for which care should be sought (at day 10) Number of baby danger signs named for which care should be sought (at day 10). Note: if mother lists "other" danger signs not coded, these should be coded as appropriate danger signs for which care should be sought or not
10 days after delivery (survey)
Breastfeeding
Time Frame: 10 days and 9 weeks after delivery (survey)
Fed only breastmilk in past week
10 days and 9 weeks after delivery (survey)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referrals
Time Frame: 3 days after delivery (from admin records)
Any referral made for mother Any referral made for newborn
3 days after delivery (from admin records)
Feeding behavior
Time Frame: 10 days 9 week after delivery (survey)
Fed baby at least 3 times in past 8 hours (at 10 days) Fed baby at least 2 times in past 8 hours (at 9 weeks) No complications breastfeeding in past week (at 10 days and at 9 weeks) Applied nothing/only water to umbilical stump (at 10 days) Ate any protein (at 10 days and at 9 weeks) Mentions keeping baby warm for bath (at 10 days) Feeds baby at night (at 10 days) Using any family planning method (at 9 weeks)
10 days 9 week after delivery (survey)
Care seeking regarding breastfeeding, vaccines and child wellness
Time Frame: 10 days and 9 weeks after delivery (survey)
If had complication breastfeeding, visited or called health facility (at day 10) Baby has had first vaccine course in a timely manner, should be at 6 weeks according to Kenyan recommendations (measured at 9 weeks) Baby was brought in for child wellness check up (measured at 9 weeks)
10 days and 9 weeks after delivery (survey)
Knowledge of feeding and safety
Time Frame: 10 days after delivery (survey)
Mentions feeding at least 3 times in 8 hours Knows two types of protein mother can eat Knows to keep baby warm while bathing Knows to feed baby at night Knows to keep cord clean and dry to prevent infection Knows to wash hands after going to toilet Knows to wash hands before touching/holding baby Knows to wash hands after changing diaper
10 days after delivery (survey)
Care seeking at Jacaranda Health
Time Frame: 10 days after delivery (survey)
Brought baby to JH within 10 days of delivery for any reason Mother came to JH within 10 days of delivery for any reason Brought baby to JH within 10 days of delivery for well-baby visit
10 days after delivery (survey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Saving Lives at Birth

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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