Clinical trial NCT02104635: Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal and Newborn Health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Jessica Cohen, Harvard School of Public Health
name: Saving Lives at Birth Initiative
name: Jacaranda Health
First posted: 2014-04-04
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complications detected
timeFrame: 3 days after delivery
measure: Successful referrals
timeFrame: 10 days after delivery (survey and administrative records)
measure: Care Seeking Behavior around complications and well baby check-up
timeFrame: 10 days after delivery (survey)
measure: Knowledge of danger signs
timeFrame: 10 days after delivery (survey)
measure: Breastfeeding
timeFrame: 10 days and 9 weeks after delivery (survey)
Secondary outcomes:
measure: Referrals
timeFrame: 3 days after delivery (from admin records)
measure: Feeding behavior
timeFrame: 10 days 9 week after delivery (survey)
measure: Care seeking regarding breastfeeding, vaccines and child wellness
timeFrame: 10 days and 9 weeks after delivery (survey)
measure: Knowledge of feeding and safety
timeFrame: 10 days after delivery (survey)
measure: Care seeking at Jacaranda Health
timeFrame: 10 days after delivery (survey)
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Jacaranda Health
Study officials:
References:
citation: 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.