Family Led Postnatal Care in Ethiopia

NCT05563974 | Completed

• 1 other identifier: IRB00021096
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postnatal Complication

Outcome Measures

Primary Outcomes (6)

• Change in coverage (Mothers)

  Between pre-intervention (for approximately 8 weeks) and immediately after the intervention (for approximately 8 weeks), the investigators will measure the change in the proportion of postnatal women who have all three postnatal checks (within 1st day, 2nd-3rd days, and 4th-7th days).

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in coverage (Newborns)

  Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of newborns who have all three postnatal checks (within 1st day, 2nd-3rd days, and 4th-7th days).

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in completeness (Mothers)

  Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of postnatal women who had all specified PNC components assessed during all three postnatal checks (within 1st day, 2nd-3rd days, and 4th-7th days).

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in completeness (Newborns)

  Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of newborns who had all specified PNC components assessed during all three postnatal checks (within 1st day, 2nd-3rd days, and 4th-7th days).

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in postnatal Contacts (Mothers)

  Between pre-intervention and immediately after the intervention, the investigators will measure the change in the average number of PNC checks that are done for mothers in the first 7 days after delivery.

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in postnatal Contacts (Newborns)

  Between pre-intervention and immediately after the intervention, the investigators will measure the change in the average number of PNC checks that are done for newborns in the first 7 days after delivery.

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

Secondary Outcomes (24)

• Change in Danger Sign Recognition (Mothers)

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in Danger Sign Recognition (Newborns)

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).

• Change in Care-Seeking (Mothers)

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)

• Change in Care-Seeking (Newborns)

  Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)

• Feasibility (Homecare Kit)

  Immediately after the intervention (for approximately 8 weeks)

Study Arms (2)

Women who agree to receive family led postnatal care

EXPERIMENTAL

This group will receive Family-led Postnatal Care-FPNC

Other: Family led postnatal care

Women who receive standard of care for postnatal care

NO INTERVENTION

Women will get the standard of care for postnatal care

Interventions

Family led postnatal care OTHER

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 and guides them how to retrieve a "home care 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 home care kit to the community location.

Women who agree to receive family led postnatal care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jhpiego: lead
• Addis Continental Institute of Public Health: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Health centers in Ada Woreda

Bishoftu, Oromiya, Ethiopia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research lead

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: October 3, 2022
• Study Start: November 14, 2022
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)