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Family Led Postnatal Care in Ethiopia (FPNC)

J

Jhpiego

Status

Completed

Conditions

Postnatal Complication

Treatments

Other: Family led postnatal care

Study type

Interventional

Funder types

Other

Identifiers

NCT05563974
IRB00021096

Details and patient eligibility

About

Family-led Postnatal Care-FPNC A midwife involves families and uses a visual checklist to assess and counsel. The midwife then gives families the checklist along with information on how to retrieve a "homecare kit" that has a blood pressure machine, infrared thermometer, and health education booklet. At home, families assess the health of postnatal mothers and newborns for 6 days, and then return the completed checklist and homecare kit to the community location. A community health worker collects the checklists monthly. This study aims to assess the acceptability and feasibility of the FPNC and assess if FPNC increases the proportion of women/newborns who have a postnatal check in the first week after delivery and the proportion who seek care from a health provider when a postnatal danger sign is identified. The study will take approximately 12 months.

Full description

Four health centers in Ada District of Oromia will be included in the study. Prior to FPNC introduction, the investigators will conduct a baseline survey over 8 weeks to measure coverage and content of postnatal checks on Days 3 and 7, as well as care-seeking behavior.

The health centers will then implement FPNC. Postnatal women, families, midwives, health extension workers, and homecare kit custodians will have the option to accept or decline participation in the study. At the end of the first- and second-months after FPNC implementation, the investigators will conduct qualitative interviews with mothers, families, midwives, health extension workers and homecare kit custodians.

Post intervention survey will take 8 weeks and will be conducted three months after FPNC is introduced. Coverage and content of postnatal checks in the first week will be abstracted weekly from FPNC checklists and care-seeking information will be collected through face-to-face interviews. The investigators will also conduct a quantitative measurement of sustainability of the FPNC intervention six months after the deadline through facility register data abstraction and review of completed checklists.

Enrollment

229 patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Health center discharge counselors

  • Provides postnatal care at intervention health center
  • Willing to participate in study

Postnatal women and family members

  • Per participant report, age 15 years or older
  • Delivered at the intervention health centers
  • Maximum of Postnatal Day 1-3 at HC
  • Intends to remain within catchment area for first week after birth
  • Has family members who are willing to participate in the study
  • Able and willing to provide consent

Husbands

  • Per participant report, age 15 years or older
  • Husband of eligible postnatal woman who has consented to participate
  • Able and willing to provide consent

Family members

  • Per participant report, age 15 years or older
  • Family members of eligible postnatal women who have consented to participate
  • Able and willing to provide consent

Health extension workers

  • Works within catchment area of intervention health center
  • Willing to participate in study

Home care custodians

  • Able and willing to provide consent

Health facility managers

  • Able and willing to provide consent

Exclusion criteria

Health center discharge counselors

  • N/A

Postnatal women and family members

  • Women who are unable to provide valid information because of mental or other serious health condition

Husbands

  • N/A

Family members

  • 15-18 year old members who are not emancipated minors (married or have children of their own)

Health extension workers

  • Is not selected to participate (i.e., if there is more than one HEWs per health post)

Home care custodians

  • N/A

Health facility managers

  • N/A

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

229 participants in 2 patient groups

Women who agree to receive family led postnatal care
Experimental group
Description:
This group will receive Family-led Postnatal Care-FPNC
Treatment:
Other: Family led postnatal care
Women who receive standard of care for postnatal care
No Intervention group
Description:
Women will get the standard of care for postnatal care

Trial contacts and locations

1

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Central trial contact

Alemayehu Worku, PhD; Della Berhanu, PhD

Data sourced from clinicaltrials.gov

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