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| ID | Type | Description | Link |
|---|---|---|---|
| 1P20GM139733 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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?
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual doula care + routine prenatal care | Placebo Comparator |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| aspirin adherence | average percent of days aspirin was taken | From enrollment to the end of treatment at 12 weeks |
| implementation outcomes | average percent of days aspirin was taken |
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Inclusion Criteria:
Exclusion Criteria:
The study focuses on pregnant women, so females are included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66101 | United States |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2026 | Mar 2, 2026 |
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| From enrollment to the end of treatment at 12 weeks |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2026 | Feb 25, 2026 | ICF_001.pdf |