Family Led Postnatal Care in Ethiopia

Postnatal Complication Clinical Trial

— FPNC  

Official title:

Feasibility and Acceptability of a Family-led Care Model to Increase Coverage and Quality of Postnatal Care in Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563974
• Other study ID #: IRB00021096
• Status: Completed
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postnatal Complication

Intervention

Other:
• Family led postnatal care
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.

Locations

Country	Name	City	State
Ethiopia	Health centers in Ada Woreda	Bishoftu	Oromia

Sponsors (3)

Lead Sponsor	Collaborator
Jhpiego	Addis Continental Institute of Public Health, Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	Change in Danger Sign Recognition (Mothers)	Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of postnatal women who had a postnatal danger sign identified in the first week after delivery.; Proportion of newborns with a danger sign identified; Proportion of women and newborns who seek care from a health provider when a postnatal danger sign is identified (disaggregated by type of provider and type of facility)	Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Secondary	Change in Danger Sign Recognition (Newborns)	Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of newborns for whom a postnatal danger sign was identified in the first week after delivery.	Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Secondary	Change in Care-Seeking (Mothers)	Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of postnatal women who sought care for an identified danger sign (disaggregated by type of provider and type of facility) in the first week after delivery.	Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
Secondary	Change in Care-Seeking (Newborns)	Between pre-intervention and immediately after the intervention, the investigators will measure the change in the proportion of newborns for whom care was sought for an identified danger sign (disaggregated by type of provider and type of facility) in the first week after delivery.	Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
Secondary	Feasibility (Homecare Kit)	Among postnatal women who are discharged from the facility after the intervention is initiated, the proportion whose family members retrieve the homecare kit. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Blood Pressure)	Among postnatal women who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion who report successful use of the blood pressure cuff. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Thermometer, Mothers)	Among postnatal women who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion who report successful use of the thermometer for themselves.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Thermometer, Newborns)	Among postnatal women who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion of who report successful use of the thermometer to check their newborn's health. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Communication)	Among families who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion who communicate with past homecare kit users. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Kit Return)	Among families who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion who return the homecare it by day 8. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Checklist Return)	Among families who are discharged from the facility after the intervention is initiated and those whose family retrieve the homecare kit, the proportion who return the checklist to the custodian. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Checklist Collection)	Among checklist brought to the homecare kit custodian, the proportion that are collected by the health extension workers. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Functional Kits)	Among all the homecare kits distributed to custodians, the proportion that are 100% functional upon monthly checks of a random sample of homecare kits. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Feasibility (Register)	Among all the homecare kit registers distributed to custodians, the proportion that are filled completely by the homecare kit custodian. This will be part of the feasibility study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Checklist)	Among postnatal women discharged from the facilities after the intervention is initiated, the proportion that accept a checklist form the discharge counselor. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Homecare Kit)	Among postnatal women discharged from the facilities after the intervention is initiated and whose family retrieve the homecare kit, the proportion who report preferring the FPNC approach. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Perceptions of Discharge Counselors)	Investigators will use qualitative methods to understand perceptions of discharge counselors on the acceptance and support for the FPNC approach. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Perceptions of Homecare Kit Custodians)	Investigators will use qualitative methods to understand the homecare kit custodians' perceptions on the FPNC approach. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Perception of Health Managers)	Investigators will use qualitative methods with health managers to understand their perceptions on the FPNC approach. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Perceptions of Health Extension Workers)	Investigators will use qualitative methods with health extension workers to understand their perceptions on the FPNC approach. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Acceptability (Perceptions of Husbands and Family Members)	Investigators will use qualitative methods with husbands and families to understand husbands' engagement in PNC. This will be part of the acceptability study.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Preference (Families')	Among families that retrieve the homecare kit, the proportion that report a preference for the FPNC approach. This will address the area of values and preferences.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Satisfaction (Dsicharge counselors')	The proportion of discharge counselors who report satisfaction with the FPNC approach, including discharge process. This will address the area of values and preferences.	Immediately after the intervention (for approximately 8 weeks)
Secondary	Sustainability	Among all the homecare kits distributed, the proportion that are functional at six months post intervention survey. This will be part of the sustainability assessment.	Six months after the post-intervention survey.