Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- mean diastolic blood pressure
Study Overview
Brief Summary
The goal of this clinical trial is to learn if a telehealth hypertension group prenatal care program (Centering HER / HGPC-T) can improve blood pressure monitoring and aspirin adherence and help reduce early-onset preeclampsia in low-income, predominantly Black pregnant participants in Kansas who are <13 weeks gestation, age ≥18, and moderate or high risk for preeclampsia (USPSTF).
The main question[s] it aims to answer [is/are]:
Does Centering HER increase hypertension monitoring and aspirin compliance compared with usual doula care?
Is Centering HER feasible and acceptable, and what contextual factors influence implementation in community clinics?
Detailed Description
The study will compare Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch) to usual doula care + routine prenatal care to see if the intervention improves monitoring/adherence and supports better BP-related outcomes.
Participants will:
- Be randomized 2:1 to Centering HER or usual doula care.
- Complete REDCap surveys at baseline, antepartum, and postpartum.
- If assigned to Centering HER, attend 7 virtual group sessions and self-monitor/report BP and weight using a Bluetooth BP cuff/scale (± Apple Watch), and keep a medication log if applicable.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •English or Spanish speaking
- •<13 weeks gestations
- •>18 years old
- •moderate or high risk for hypertensive disorders in pregnancy
Exclusion Criteria
- •less than18 years of age
- •not receiving prenatal care
- •not eligible for doula care
- •no risk factors for hypertensive disorders in pregnancy
Arms & Interventions
usual doula care + routine prenatal care
Intervention: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group (Behavioral)
Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group
routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch
Intervention: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group (Behavioral)
Outcomes
Primary Outcomes
mean diastolic blood pressure
Time Frame: From enrollment to the end of treatment at 12 weeks
Average daily diastolic blood pressure
mean systolic blood pressure
Time Frame: From enrollment of study to end of treatment at 12 weeks
Average daily systolic blood pressure
Secondary Outcomes
- implementation outcomes(From enrollment to the end of treatment at 12 weeks)
- aspirin use(From enrollment to the end of treatment at 12 weeks)