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Clinical Trials/NCT02104635
NCT02104635CompletedNot Applicable

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

Harvard School of Public Health (HSPH)1 site in 1 country109 target enrollmentStarted: April 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
109
Locations
1
Primary Endpoint
Complications detected

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

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

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

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

Breastfeeding

Time Frame: 10 days and 9 weeks after delivery (survey)

Fed only breastmilk in past week

Secondary Outcomes

  • Referrals(3 days after delivery (from admin records))
  • Feeding behavior(10 days 9 week after delivery (survey))
  • Care seeking regarding breastfeeding, vaccines and child wellness(10 days and 9 weeks after delivery (survey))
  • Knowledge of feeding and safety(10 days after delivery (survey))
  • Care seeking at Jacaranda Health(10 days after delivery (survey))

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Margaret McConnell

Assistant Professor of Global Health Economics

Harvard School of Public Health (HSPH)

Study Sites (1)

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