Clinical trial NCT05280951: Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana
Official title: Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Care
Keywords: postpartum care
postpartum complications
maternal mortality
maternal health
Ghana
postpartum education
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: Savana Signatures
name: Indiana University School of Medicine
First posted: 2022-03-15
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, it receives much less attention than pregnancy and childbirth. Appropriate postpartum care enables healthcare providers identify and treat postpartum complications promptly, offer help with a wide range of health and social needs and encourage mothers to adopt evidenced-based postpartum practices at home, since maternal self-care usually takes place at home. In many settings in Sub-Saharan Africa, quality postpartum care, education, and support for the mother are often the missing components of postnatal care delivery, which focuses on care of the baby. The lack of standard postpartum care for the mother contributes to maternal deaths. There is an urgent need for an integrated postpartum care delivery model that is comprehensive and meets clinical care, education, and support needs of mothers. Thus, the purpose of this project is to test and evaluate an innovative postpartum care, education, and support model known as Focused-PPC, in Tamale, Ghana. The proposed project will be the first of its kind to design an integrated and comprehensive group postpartum care delivery model, focused on clinical care of the mother and baby, as well as education and peer support in Ghana. Our model supports the clinical assessments and timeframes recommended by the World Health Organization and adopted by Ghana Health Service. Together with my partner organization, Savana Signatures, we will develop and test Focused-PPC. Focused-PPC will be implemented in groups in health centers in Tamale, Ghana. Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana health service postnatal care schedule. Led by trained midwives in the health centers, each group session will consist of postpartum clinical assessments for mother (in addition to baby), education, and support. Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond. Results from this implementation will be used to further refine and scale up the Focused-PPC model of postpartum care.

Eligibility criteria: Inclusion Criteria at Recruitment:

* 18 years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)

Inclusion Criteria at Enrollment:

* 18 years and older, had a live birth, able to understand English or "Dagbani" (the local language)

Exclusion Criteria:

* Had a stillbirth

Primary outcomes:
measure: Number of Post-Birth Warning Signs Identified Per Participant
timeFrame: 1 year
Secondary outcomes:
measure: Postpartum Health Behaviors Practiced
timeFrame: 1 year
Other outcomes:
measure: postpartum health status
timeFrame: 1 year
measure: Overall Satisfaction of Focused-PPC Sessions
timeFrame: 1 year
Locations:
city: Tamale
country: Ghana
facility: Bagabaga Health Center
city: Tamale
country: Ghana
facility: Choggu Health Center
city: Tamale
country: Ghana
facility: Kalpohin Health Center
city: Tamale
country: Ghana
facility: Kanvilli Health Center
Study officials:
affiliation: University of Notre Dame
name: Yenupini J Adams, PhD, BSN
role: PRINCIPAL_INVESTIGATOR
References: