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

July 2, 2026 updated by: University of Kansas Medical Center

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

Enrolling by invitation

Conditions

Intervention / Treatment

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)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66101
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
mean diastolic blood pressure
Time Frame: From enrollment to the end of treatment at 12 weeks
Average daily diastolic blood pressure
From enrollment to the end of treatment at 12 weeks
mean systolic blood pressure
Time Frame: From enrollment of study to end of treatment at 12 weeks
Average daily systolic blood pressure
From enrollment of study to end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aspirin adherence
Time Frame: From enrollment to the end of treatment at 12 weeks
average percent of days aspirin was taken
From enrollment to the end of treatment at 12 weeks
implementation outcomes
Time Frame: From enrollment to the end of treatment at 12 weeks
average percent of days aspirin was taken
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 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)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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