Pregnancy Clinical Trial
— P?OPPYOfficial title:
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 31, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 49 Years |
Eligibility | Inclusion Criteria: - Self Identifies as Non-Hispanic Black - Between 16-49 years old - Pregnant individuals between 8° - 226 weeks gestational age - Live singleton or dichorionic twin gestation - Dating sonogram at <23 weeks gestation - Area Deprivation Index (ADI) National 4th or 5th Quintile - Planning to deliver at UAB Hospital - Speaks and writes in English - No indication for delivery at the time of enrollment Exclusion Criteria: - Declines randomization - Speaks or writes in languages other than English - Currently incarcerated - Fetal demise diagnosed prior to enrollment - Known major structural chromosomal abnormalities prior to enrollment |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | American Heart Association, ConnectionHealth, Memora Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant acceptance of randomization arm / intervention | Participant acceptance is defined as a yes response to this question:
"I would recommend the care I received to someone in a similar situation." |
From randomization to 6 weeks postpartum | |
Primary | Participant use of digital health and/or community health worker interventions | Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker. | From randomization to 6 weeks postpartum | |
Secondary | Outpatient Prenatal Care Visits | Number of outpatient prenatal care and postpartum visits | Duration of pregnancy through 6 weeks postpartum | |
Secondary | Preterm Birth | Delivery of a neonate at less than 37 weeks | At birth | |
Secondary | Neonatal birthweight | Weight of neonate at birth | At birth | |
Secondary | Cesarean delivery | Occurrence of a cesarean birth | At birth | |
Secondary | Maternal blood transfusion | Transfusion of blood products | Duration of pregnancy through 6 weeks postpartum | |
Secondary | Breastfeeding intent | Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization | From randomization to delivery of the infant(s) | |
Secondary | Vaccination rate | The number of recommended vaccinations for which the mother and newborn accepted | Pregnancy through 6 weeks postpartum / 6 weeks of life | |
Secondary | Maternal postpartum readmission | Admission of the mother to the hospital after discharge from the delivery-associated hospitalization | From discharge from the delivery-associated hospitalization to 6 weeks postpartum | |
Secondary | Neonatal hospital readmission | Admission of a neonate to the hospital after discharge from the hospital after birth | Birth to 6 weeks of life |
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