Aspirin Prophylaxis, Monitoring Blood Pressure
Conditions
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.
Interventions
BEHAVIORALActive Comparator: 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
Sponsors
University of Kansas Medical Center
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
* 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean diastolic blood pressure | From enrollment to the end of treatment at 12 weeks | Average daily diastolic blood pressure |
| mean systolic blood pressure | From enrollment of study to end of treatment at 12 weeks | Average daily systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aspirin use | From enrollment to the end of treatment at 12 weeks | Aspirin use or not |
| implementation outcomes | From enrollment to the end of treatment at 12 weeks | Number of intervention sessions attended |
Countries
United States
Outcome results
None listed