An interventional study of Focused-PPC Care and Usual Care in Postpartum Care, sponsored by University of Notre Dame. Status unknown at 4 sites in Ghana. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by University of Notre Dame · Not applicable, Interventional, and Prevention
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.
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 192 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →University of Notre Dame is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria at Recruitment:
Inclusion Criteria at Enrollment:
Exclusion Criteria:
Focused-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.
Other: Focused-PPC Care
The control group will contain parallel number of participants as the intervention group in each health center
Other: Usual Care
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.
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.
Time frame: 1 year
Postpartum Health Behaviors Practiced
Postpartum Health Behaviors will be assessed using a questionnaire. The questionnaire will identify which PNC visits the participant attended, how participants feed their baby, how often the participant adheres to the 4-star diet, feelings on getting pregnant within 6 months of giving birth, plans on getting pregnant within 6 months of giving birth, and intentions on getting pregnant within 6 months of giving birth. The researchers expect health behaviors to be different between the Focused-PPC and control groups. All health behavior questions are all categorical and will be aggregated using latent class analysis.
Time frame: 1 year
postpartum health status
overall health and mental health
Time frame: 1 year
Overall Satisfaction of Focused-PPC Sessions
Using a questionnaire, we will record how satisfied participants were with the education received during the Focused-PPC sessions, the clinical care received during the Focused-PPC sessions, whether length of sessions was satisfactory or disliked, whether length of sessions was satisfactory or disliked, whether information provided was satisfactory or disliked, whether peer support was satisfactory or disliked, and whether the group format was liked by participants. These measures are all categorical and will be aggregated using factor analysis.
Time frame: 1 year
Plan to share: No
Started Feb 2022 (actual). Primary completion is estimated for Jan 2023, 11 months after the start.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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