NCT02104635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

April 2, 2014

Last Update Submit

December 1, 2014

Conditions

Outcome Measures

Primary Outcomes (5)

  • Complications detected

    Any maternal complications detected Number of maternal complications detected Any newborn complications detected Number of newborn complications detected

    3 days after delivery

  • 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)

  • 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)

  • 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)

  • Breastfeeding

    Fed only breastmilk in past week

    10 days and 9 weeks after delivery (survey)

Secondary Outcomes (5)

  • Referrals

    3 days after delivery (from admin records)

  • Feeding behavior

    10 days 9 week after delivery (survey)

  • Care seeking regarding breastfeeding, vaccines and child wellness

    10 days and 9 weeks after delivery (survey)

  • Knowledge of feeding and safety

    10 days after delivery (survey)

  • Care seeking at Jacaranda Health

    10 days after delivery (survey)

Study Arms (3)

Control group

NO INTERVENTION

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.

CHW-Visit

EXPERIMENTAL

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

CHW-Phone

EXPERIMENTAL

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

Interventions

CHW-PhoneCHW-Visit

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacaranda Health

Nairobi, Kenya

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Global Health Economics

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations