Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Neonatal Birthweight percentile
研究概览
简要总结
The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of <130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Viable singleton gestation
- •No fetal anomalies
- •Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation
- •Planning to deliver at UAB Hospital
- •No indication for pregnancy termination
- •Receiving care at the UAB prenatal clinics
排除标准
- •Declines Randomization
- •Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use
- •Fetal demise diagnosed prior to enrollment
- •Known major structural of chromosomal abnormalities prior to enrollment
- •Contraindication to first line antihypertensive (Nifedipine/ Labetalol)
- •Comorbidities requiring BP goals < 130/80mmHg
研究组 & 干预措施
BP goal <140/90 (usual care)
BP goal <130/80mmHg
干预措施: Labetalol or Nifedipine (Drug)
结局指标
主要结局
Neonatal Birthweight percentile
时间窗: at delivery of infant
To determine whether anti-HTN treatment to BP\<130/80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery
次要结局
未报告次要终点
研究者
Rachel Sinkey
Principal Investigator
University of Alabama at Birmingham