Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana
Focused-PPC
1 other identifier
interventional
192
1 country
4
Brief Summary
The purpose of this project is to test and evaluate an innovative postpartum care, education, and support model that integrates recommended clinical care, education, and support for women in a group setting. Aim 1. Develop an innovative integrated group postpartum care, education, and support model entitled Focused-PPC for postpartum women up to one year after delivery. Aim 2. Implement and evaluate this integrated postpartum care model entitled Focused-PPC in a parallel randomized controlled trial with 192 postpartum women at 4 health centers in Tamale, Ghana.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedStudy Start
First participant enrolled
February 26, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 15, 2022
March 1, 2022
10 months
February 10, 2022
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Post-Birth Warning Signs Identified Per Participant
Knowledge of post-birth warning signs will be assessed using a question that asks participants to identify (check all that apply) warning signs of complications. Response options will include nine post-birth warning signs. Each item will be recorded as dichotomous, with a value of 1 assigned if the woman identified the warning sign and 0 if she did not. The total knowledge score will be the sum of these dichotomous items. The mean knowledge score will be calculated as the total knowledge score divided by 9 and reflect the percentage of warning signs known. We will model and test the between treatment and control group's knowledge of post-birth warning signs at each timepoint and between timepoints will be assessed using a repeated measure multivariate analysis of variance (MANOVA) with a time and treatment interaction will be run as the primary analysis controlling for baseline demographic variables.
1 year
Secondary Outcomes (1)
Postpartum Health Behaviors Practiced
1 year
Other Outcomes (2)
postpartum health status
1 year
Overall Satisfaction of Focused-PPC Sessions
1 year
Study Arms (2)
Focused-PPC Group
EXPERIMENTALFocused-PPC will be implemented in 12 groups (3 groups per health center), with each group having 8 postpartum women. Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana Health Service (GHS) postnatal care schedule.
Standard PNC Group
ACTIVE COMPARATORThe control group will contain parallel number of participants as the intervention group in each health center
Interventions
Individual clinical assessments and counseling for each group member will last about 15 minutes. Then, there will be 1 hour of group time dedicated to education and support. Each group session will be led by two trained and registered midwives who will provide both clinical care, education, and support as needed. In addition, each group session will be supported by a project assistant. Focused-PPC will be implemented in addition to newborn care.
Women in the control group will receive standard postnatal care (PNC) currently practiced in the health centers. This involves attending PNC visits at the health center within 14 days after birth, at 6 weeks, and monthly thereafter up to one year.
Eligibility Criteria
You may qualify if:
- years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)
- years and older, had a live birth, able to understand English or "Dagbani" (the local language)
You may not qualify if:
- Had a stillbirth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Notre Damelead
- Savana Signaturescollaborator
- Indiana University School of Medicinecollaborator
Study Sites (4)
Bagabaga Health Center
Tamale, Ghana
Choggu Health Center
Tamale, Ghana
Kalpohin Health Center
Tamale, Ghana
Kanvilli Health Center
Tamale, Ghana
Related Publications (2)
Adams YJ, Agbenyo JS, Lau E, Young J, Haas D. Randomized Trial of Group Postpartum Care Model Improves Knowledge and Clinical Outcomes. Nurs Res. 2025 May-Jun 01;74(3):171-178. doi: 10.1097/NNR.0000000000000814. Epub 2025 Feb 13.
PMID: 39968953DERIVEDAdams YJ, Agbenyo JS. Improving the Quality of Postpartum Care in Ghana: Protocol for a Parallel Randomized Controlled Trial. JMIR Res Protoc. 2023 Aug 22;12:e47519. doi: 10.2196/47519.
PMID: 37606965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yenupini J Adams, PhD, BSN
University of Notre Dame
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 15, 2022
Study Start
February 26, 2022
Primary Completion
January 1, 2023
Study Completion
June 1, 2023
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share