Clinical trial NCT05563974: Family Led Postnatal Care in Ethiopia
Official title: Feasibility and Acceptability of a Family-led Care Model to Increase Coverage and Quality of Postnatal Care in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Complication
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: Bill and Melinda Gates Foundation
First posted: 2022-10-03
Enrollment: 229
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in coverage (Mothers)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in coverage (Newborns)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in completeness (Mothers)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in completeness (Newborns)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in postnatal Contacts (Mothers)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in postnatal Contacts (Newborns)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Secondary outcomes:
measure: Change in Danger Sign Recognition (Mothers)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in Danger Sign Recognition (Newborns)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
measure: Change in Care-Seeking (Mothers)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
measure: Change in Care-Seeking (Newborns)
timeFrame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
measure: Feasibility (Homecare Kit)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Blood Pressure)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Thermometer, Mothers)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Thermometer, Newborns)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Communication)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Kit Return)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Checklist Return)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Checklist Collection)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Functional Kits)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Feasibility (Register)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Checklist)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Homecare Kit)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Perceptions of Discharge Counselors)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Perceptions of Homecare Kit Custodians)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Perception of Health Managers)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Perceptions of Health Extension Workers)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Acceptability (Perceptions of Husbands and Family Members)
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Preference (Families')
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Satisfaction (Dsicharge counselors')
timeFrame: Immediately after the intervention (for approximately 8 weeks)
measure: Sustainability
timeFrame: Six months after the post-intervention survey.
Other outcomes:
Locations:
city: Bishoftu
country: Ethiopia
facility: Health centers in Ada Woreda
state: Oromia
Study officials:
References: