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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02104635
• Date of registration: 02/04/2014
• Prospective Registration: No
• Primary sponsor: Harvard School of Public Health
• Public title: Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya
• Date of first enrolment: April 2014
• Target sample size: 109
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02104635
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Kenya

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Maternal and Newborn Health

Intervention(s)

Behavioral: Delivery of a Post-Partum Package

Primary Outcome(s)

Care Seeking Behavior around complications and well baby check-up [Time Frame: 10 days after delivery (survey)]

Knowledge of danger signs [Time Frame: 10 days after delivery (survey)]

Complications detected [Time Frame: 3 days after delivery]

Successful referrals [Time Frame: 10 days after delivery (survey and administrative records)]

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

Secondary Outcome(s)

Care seeking regarding breastfeeding, vaccines and child wellness [Time Frame: 10 days and 9 weeks after delivery (survey)]

Knowledge of feeding and safety [Time Frame: 10 days after delivery (survey)]

Referrals [Time Frame: 3 days after delivery (from admin records)]

Care seeking at Jacaranda Health [Time Frame: 10 days after delivery (survey)]

Feeding behavior [Time Frame: 10 days 9 week after delivery (survey)]

Secondary ID(s)

Saving Lives at Birth

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Saving Lives at Birth Initiative

Jacaranda Health

Jessica Cohen, Harvard School of Public Health