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OpenTrials
Completed

NCT Number: NCT02104635

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jacaranda Health

Nairobi, Kenya

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delivery of a Post-Partum Package

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Breastfeeding

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

    Fed only breastmilk in past week

Secondary outcomes

  1. Referrals

    Time frame: 3 days after delivery (from admin records)

    Any referral made for mother Any referral made for newborn

  2. 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)

  3. 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)

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Jacaranda Health
  • Jessica Cohen, Harvard School of Public Health
  • Saving Lives at Birth Initiative

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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