Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana (Focused-PPC)
4 mars 2022 uppdaterad av: University of Notre Dame
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
192
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Principal Investigator
- Telefonnummer: +1 574 631 3224
- E-post: yadams@nd.edu
Studieorter
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Tamale, Ghana
- Rekrytering
- Bagabaga Health Center
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Kontakt:
- Project Manager
- Telefonnummer: +233243601588
- E-post: emefa@savsign.org
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Tamale, Ghana
- Rekrytering
- Choggu Health Center
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Kontakt:
- Project Manager
- Telefonnummer: +233243601588
- E-post: emefa@savsign.org
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Tamale, Ghana
- Rekrytering
- Kalpohin Health Center
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Kontakt:
- Project Manager
- Telefonnummer: +233243601588
- E-post: emefa@savsign.org
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Tamale, Ghana
- Rekrytering
- Kanvilli Health Center
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Kontakt:
- Project Manager
- Telefonnummer: +233243601588
- E-post: emefa@savsign.org
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Focused-PPC Group
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.
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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.
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Aktiv komparator: Standard PNC Group
The control group will contain parallel number of participants as the intervention group in each health center
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Post-Birth Warning Signs Identified Per Participant
Tidsram: 1 year
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postpartum Health Behaviors Practiced
Tidsram: 1 year
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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.
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1 year
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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postpartum health status
Tidsram: 1 year
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overall health and mental health
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1 year
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Overall Satisfaction of Focused-PPC Sessions
Tidsram: 1 year
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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.
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1 year
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yenupini J Adams, PhD, BSN, University of Notre Dame
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 februari 2022
Primärt slutförande (Förväntat)
1 januari 2023
Avslutad studie (Förväntat)
1 juni 2023
Studieregistreringsdatum
Först inskickad
10 februari 2022
Först inskickad som uppfyllde QC-kriterierna
4 mars 2022
Första postat (Faktisk)
15 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 21-06-6662
Plan för individuella deltagardata (IPD)
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NEJ
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