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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104635
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : December 2, 2014
Sponsor:
Collaborators:
Jessica Cohen, Harvard School of Public Health
Saving Lives at Birth Initiative
Jacaranda Health
Information provided by (Responsible Party):
Margaret McConnell, Harvard School of Public Health

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.

Condition or disease Intervention/treatment Phase
Maternal and Newborn Health Behavioral: Delivery of a Post-Partum Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Basic Science
Study Start Date : April 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
No Intervention: Control group
The control group receives standard of care from Jacaranda clinic and does not receive any additional post-partum check-in from a community health worker.
Experimental: CHW-Visit
The CHW-Visit group will receive a visit at their home from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check.
Behavioral: Delivery of a Post-Partum Package
Experimental: CHW-Phone
The CHW-Visit group will receive a phone call from a community health worker (CHW) three days after delivery. The CHW will administer a checklist designed to identify maternal and newborn complications and will provide information about positive maternal health and care behaviors. The CHW will encourage women to return to the clinic at 7 days to receive a well-baby check.
Behavioral: Delivery of a Post-Partum Package



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104635


Locations
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Kenya
Jacaranda Health
Nairobi, Kenya
Sponsors and Collaborators
Harvard School of Public Health
Jessica Cohen, Harvard School of Public Health
Saving Lives at Birth Initiative
Jacaranda Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margaret McConnell, Assistant Professor of Global Health Economics, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02104635    
Other Study ID Numbers: Saving Lives at Birth
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014