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

Maternal and Newborn Health Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104635
• Other study ID #: Saving Lives at Birth
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: December 1, 2014
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Maternal and Newborn Health

Intervention

Behavioral:
• Delivery of a Post-Partum Package

Locations

Country	Name	City	State
Kenya	Jacaranda Health	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Jacaranda Health, Jessica Cohen, Harvard School of Public Health, Saving Lives at Birth Initiative

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications detected	Any maternal complications detected Number of maternal complications detected Any newborn complications detected Number of newborn complications detected	3 days after delivery
Primary	Successful referrals	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)
Primary	Care Seeking Behavior around complications and well baby check-up	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)
Primary	Knowledge of danger signs	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)
Primary	Breastfeeding	Fed only breastmilk in past week	10 days and 9 weeks after delivery (survey)
Secondary	Referrals	Any referral made for mother Any referral made for newborn	3 days after delivery (from admin records)
Secondary	Feeding behavior	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)
Secondary	Care seeking regarding breastfeeding, vaccines and child wellness	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)
Secondary	Knowledge of feeding and safety	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)
Secondary	Care seeking at Jacaranda Health	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)