Postpartum CareFocused-PPCNCT05280951
Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana
A study testing Focused-PPC Care in people with Postpartum Care, run by University of Notre Dame at 4 sites in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Care
- What is being tested?
- Focused-PPC Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesGhana
- Study dates
- 26 Feb 2022to Jun 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)
- 18 years and older, had a live birth, able to understand English or "Dagbani" (the local language)
Who cannot join
- Had a stillbirth
Trial locations and contacts
4 sites in 1 country.
Ghana4 sites, 4 recruiting
- Recruiting
Bagabaga Health Center
Tamale
Project Manager, +233243601588, emefa@savsign.org
- Recruiting
Choggu Health Center
Tamale
Project Manager, +233243601588, emefa@savsign.org
- Recruiting
Kalpohin Health Center
Tamale
Project Manager, +233243601588, emefa@savsign.org
- Recruiting
Kanvilli Health Center
Tamale
Project Manager, +233243601588, emefa@savsign.org
About this study
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.
Read the 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.
- Conditions
- Postpartum Care
- Being tested
- Focused-PPC Care, Usual Care
- Keywords
- postpartum care, postpartum complications, maternal mortality, maternal health, Ghana, postpartum education
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused-PPC CareOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused-PPC Group | Experimental | 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. Receives: Other: Focused-PPC Care |
| Standard PNC Group | Active comparator | The control group will contain parallel number of participants as the intervention group in each health center Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start26 Feb 2022
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
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 Postpartum CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- Savana Signatures, Indiana University
- Responsible party
- Sponsor
- Investigators
- Yenupini J Adams, PhD, BSN, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280951
- Sponsor's protocol ID
- 21-06-6662
- Acronym
- Focused-PPC
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39968953Adams 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.
PubMed 37606965
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana
- ClinicalTrials.gov ID
- NCT05280951
- Acronym / sponsor ID
- Focused-PPC / 21-06-6662
- Conditions
- Postpartum Care
- Keywords
- postpartum care, postpartum complications, maternal mortality, maternal health, Ghana, postpartum education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- Savana Signatures, Indiana University
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Mar 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused-PPC Group | Experimental | Other: Focused-PPC CareFocused-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 comparator | Other: Usual CareThe control group will contain parallel number of participants as the intervention group in each health center |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)
- 18 years and older, had a live birth, able to understand English or "Dagbani" (the local language)
Key exclusion criteria (1 listed)
- Had a stillbirth
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 |
|---|---|---|
| Focused-PPC CareIndividual 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. | Other | Focused-PPC Group |
| Usual CareWomen 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. | Other | Standard PNC Group |
Primary outcome
Number of Post-Birth Warning Signs Identified Per Participant
Time frame: 1 year
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 secondary outcome
Postpartum Health Behaviors Practiced
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 39968953Adams 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.
- Derived from this study: PubMed 37606965Adams 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.
- Individual participant dataSharing planned: No
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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.
Yenupini J Adams, PhD, BSN principal investigator
University of Notre Dame
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused-PPC Care in people with Postpartum Care, run by University of Notre Dame at 4 sites in Ghana.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ghana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (+1 574 631 3224, yadams@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Post-Birth Warning Signs Identified Per Participant (time frame: 1 year). 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 NCT05280951, 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 15 Mar 2022.