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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07491510
Status
Enrolling By Invitation

Conditions

  • Aspirin Prophylaxis
  • Monitoring Blood Pressure

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group — BEHAVIORAL
    routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch

Study Details

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?

Key Dates

Start date
Aug 1, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: usual doula care + routine prenatal care
  • Active 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

Primary Outcome Measure

mean diastolic blood pressure [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66101-

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KS

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