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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: High Blood Pressure (& [Essential Hypertension])
• Intervention / Treatment: Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: usual doula care + routine prenatal care	Behavioral: 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
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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Hypertensive-range BP is defined as SBP ≥140 and/or DBP ≥90 mm Hg; severe-range BP is SBP ≥160 and/or DBP ≥110 mm Hg.	Week 1- Week 12; delivery, and 3 and 6 months postpartum

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension
• Other Study ID Numbers: STUDY00160319; 1P20GM139733 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will not be shared with other researchers outside of the study team to date. Currently the decision is undecided unless IRB approved to share with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No