Postnatal ComplicationFPNCNCT05563974
Family Led Postnatal Care in Ethiopia
A study testing Family led postnatal care in people with Postnatal Complication, run by Jhpiego at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postnatal Complication
- What is being tested?
- Family led postnatal care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteEthiopia
- Study dates
- 14 Nov 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a Family-led Care Model to Increase Coverage and Quality of Postnatal Care in Ethiopia
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.
Read the 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.
- Conditions
- Postnatal Complication
- Being tested
- Family led postnatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family led postnatal careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Women who agree to receive family led postnatal care | Experimental | This group will receive Family-led Postnatal Care-FPNC Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Secondary outcomes (24)
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)
Measured: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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.
Measured: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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.
Measured: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
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.
Measured: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Immediately after the intervention (for approximately 8 weeks)
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.
Measured: Six months after the post-intervention survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start14 Nov 2022
- Primary completion30 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postnatal ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Della Berhanu, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563974
- Sponsor's protocol ID
- IRB00021096
- Acronym
- FPNC
- Status last verified
- Apr 2024
- First submitted
- 30 Aug 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Per current Bill \& Melinda Gates Foundation policy for study data
Publications
Regassa GB, Berhanu D, Wolde K, Teshite D, Amdissa L, Yallew WW, Alem SG, Sripad P, Hyre A, Noguchi L, Worku A. Changes in postnatal outcomes following implementation of a family-led postnatal care model: A pre-post intervention study in Ada'a District, Ethiopia. PLOS Glob Public Health. 2026 Oct 30;6(10):e0006487. doi: 10.1371/journal.pgph.0006487. eCollection 2026.
PubMed 42961861Regassa GB, Wolde K, Teshite DT, Amdissa L, Yallew WW, Alem SG, Sripad P, Hyre A, Suhowatsky S, Noguchi L, Yalew AW, Berhanu D. Feasibility, acceptability and sustainability of family-led postnatal care model: a multisite mixed study in Ada'a District, Ethiopia. BMJ Public Health. 2026 May 12;4(2):e003548. doi: 10.1136/bmjph-2025-003548. eCollection 2026.
PubMed 42158542
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Family-led Care Model to Increase Coverage and Quality of Postnatal Care in Ethiopia
- ClinicalTrials.gov ID
- NCT05563974
- Acronym / sponsor ID
- FPNC / IRB00021096
- Conditions
- Postnatal Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Bill and Melinda Gates Foundation
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women who agree to receive family led postnatal care | Experimental | Other: Family led postnatal careThis group will receive Family-led Postnatal Care-FPNC |
| Women who receive standard of care for postnatal care | No intervention | –Women will get the standard of care for postnatal care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family led postnatal careFamily-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. | Other | Women who agree to receive family led postnatal care |
Primary outcome
Change in coverage (Mothers)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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).
Change in coverage (Newborns)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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).
Change in completeness (Mothers)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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).
Change in completeness (Newborns)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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).
Change in postnatal Contacts (Mothers)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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.
Change in postnatal Contacts (Newborns)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
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.
24 secondary outcomes
Change in Danger Sign Recognition (Mothers)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Change in Danger Sign Recognition (Newborns)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).
Change in Care-Seeking (Mothers)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
Change in Care-Seeking (Newborns)
Time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks)
Feasibility (Homecare Kit)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Blood Pressure)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Thermometer, Mothers)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Thermometer, Newborns)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Communication)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Kit Return)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Checklist Return)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Checklist Collection)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Functional Kits)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Feasibility (Register)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Checklist)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Homecare Kit)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Perceptions of Discharge Counselors)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Perceptions of Homecare Kit Custodians)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Perception of Health Managers)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Perceptions of Health Extension Workers)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Acceptability (Perceptions of Husbands and Family Members)
Time frame: Immediately after the intervention (for approximately 8 weeks)
Preference (Families')
Time frame: Immediately after the intervention (for approximately 8 weeks)
Satisfaction (Dsicharge counselors')
Time frame: Immediately after the intervention (for approximately 8 weeks)
Sustainability
Time frame: Six months after the post-intervention survey.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 42961861Regassa GB, Berhanu D, Wolde K, Teshite D, Amdissa L, Yallew WW, Alem SG, Sripad P, Hyre A, Noguchi L, Worku A. Changes in postnatal outcomes following implementation of a family-led postnatal care model: A pre-post intervention study in Ada'a District, Ethiopia. PLOS Glob Public Health. 2026 Oct 30;6(10):e0006487. doi: 10.1371/journal.pgph.0006487. eCollection 2026.
- Derived from this study: PubMed 42158542Regassa GB, Wolde K, Teshite DT, Amdissa L, Yallew WW, Alem SG, Sripad P, Hyre A, Suhowatsky S, Noguchi L, Yalew AW, Berhanu D. Feasibility, acceptability and sustainability of family-led postnatal care model: a multisite mixed study in Ada'a District, Ethiopia. BMJ Public Health. 2026 May 12;4(2):e003548. doi: 10.1136/bmjph-2025-003548. eCollection 2026.
- Individual participant dataSharing planned: No. Per current Bill \& Melinda Gates Foundation policy for study data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family led postnatal care in people with Postnatal Complication, run by Jhpiego at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coverage (Mothers) (time frame: Pre-intervention (for approximately 8 weeks) and immediately after intervention (for approximately 8 weeks).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563974, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.