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Not Yet RecruitingNCT07491510

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
72 (estimated)
Sponsor
University of Kansas Medical Center · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2026-03-20
Primary completion
2026-09-30
Completion
2026-12-15
First posted
2026-03-24
Last updated
2026-03-24

Source: ClinicalTrials.gov record NCT07491510. Inclusion in this directory is not an endorsement.