Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income

University of Kansas

Status: Invitation-only

Conditions: Monitoring Blood Pressure; Aspirin Prophylaxis

Treatments: Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07491510

STUDY00160319

1P20GM139733 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

usual doula care + routine prenatal care

Placebo Comparator group

Treatment:

Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group

Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group

Active Comparator group

Description:

routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch

Treatment:

Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group