Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group.
- Who it may be relevant to
- Registry conditions: Monitoring Blood Pressure, Aspirin Prophylaxis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
Overview
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.
Interventions
- 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
Primary outcome measures
- mean diastolic blood pressure [Time frame: 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]
Secondary outcome measures (2)
- aspirin adherence [Time frame: From enrollment to the end of treatment at 12 weeks]
- implementation outcomes [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07491510 · STUDY00160319 · 1P20GM139733