NCT07491510

Brief 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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

January 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

January 30, 2026

Last Update Submit

July 2, 2026

Conditions

Monitoring Blood PressureAspirin Prophylaxis

Outcome Measures

Primary Outcomes (2)

  • mean diastolic blood pressure

    Average daily diastolic blood pressure

    From enrollment to the end of treatment at 12 weeks

  • mean systolic blood pressure

    Average daily systolic blood pressure

    From enrollment of study to end of treatment at 12 weeks

Secondary Outcomes (2)

  • aspirin adherence

    From enrollment to the end of treatment at 12 weeks

  • implementation outcomes

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

usual doula care + routine prenatal care

PLACEBO COMPARATOR
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

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

Interventions

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

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

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study focuses on pregnant women, so females are included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English or Spanish speaking
  • \<13 weeks gestations
  • \>18 years old
  • moderate or high risk for hypertensive disorders in pregnancy

You may not qualify if:

  • less than18 years of age
  • not receiving prenatal care
  • not eligible for doula care
  • no risk factors for hypertensive disorders in pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66101, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: * 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

March 24, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)