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Enrolling by Invitation

NCT Number: NCT07491510

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

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?

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Key information

Conditions

Monitoring Blood Pressure Aspirin Prophylaxis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. mean diastolic blood pressure

    Time frame: From enrollment to the end of treatment at 12 weeks

    Average daily diastolic blood pressure

  2. mean systolic blood pressure

    Time frame: From enrollment of study to end of treatment at 12 weeks

    Average daily systolic blood pressure

Secondary outcomes

  1. aspirin adherence

    Time frame: From enrollment to the end of treatment at 12 weeks

    average percent of days aspirin was taken

  2. implementation outcomes

    Time frame: From enrollment to the end of treatment at 12 weeks

    average percent of days aspirin was taken

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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