Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- mean diastolic blood pressure
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English or Spanish speaking
- •<13 weeks gestations
- •>18 years old
- •moderate or high risk for hypertensive disorders in pregnancy
排除标准
- •less than18 years of age
- •not receiving prenatal care
- •not eligible for doula care
- •no risk factors for hypertensive disorders in pregnancy
研究组 & 干预措施
usual doula care + routine prenatal care
干预措施: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group (Behavioral)
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
干预措施: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group (Behavioral)
结局指标
主要结局
mean diastolic blood pressure
时间窗: From enrollment to the end of treatment at 12 weeks
Average daily diastolic blood pressure
mean systolic blood pressure
时间窗: From enrollment of study to end of treatment at 12 weeks
Average daily systolic blood pressure
Blood Pressure
时间窗: Week 1- Week 12; delivery, and 3 and 6 months postpartum
Hypertensive-range BP is defined as SBP ≥140 and/or DBP ≥90 mm Hg; severe-range BP is SBP ≥160 and/or DBP ≥110 mm Hg.
次要结局
- aspirin adherence(From enrollment to the end of treatment at 12 weeks)
- implementation outcomes(From enrollment to the end of treatment at 12 weeks)
- aspirin use(From enrollment to the end of treatment at 12 weeks)