Treatment of Elevated Blood Pressures in Early Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Treatment of elevated blood pressures
研究概览
简要总结
This is a randomized controlled trial comparing the outcomes of treatment and non-treatment of elevated blood pressures in early pregnancy.
详细描述
Patients will be randomized to treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment. After randomization to treatment, patient's will be treated with either nifedipine or labetalol (both medications that are standard of care for treatment of elevated blood pressure during pregnancy).
The purpose of this study is two-fold: 1) Determine if treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic) versus non-treatment improves maternal and fetal outcomes and 2) determine if ICG directed treatment is optimal as ICG will not be used to determine treatment medication (this will be done by secondary analysis after conclusion of the study).
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting for obstetric care at Marshall University (Huntington office and Teays Valley office) between 12 and 16 weeks gestation with a systolic blood pressure of 120 or greater OR a diastolic blood pressure of 80 or greater. Eligibility for this study will be have blood pressures between 120-139 systolic and 80-89 diastolic. Randomization to control, labetalol, or nifedipine will be performed after patient consent.
排除标准
- •Patients already be on medication for hypertension.
- •Patients with the diagnosis of chronic hypertension
- •Patients with a BP of 140 or greater systolic OR 90 or greater diastolic (this meets criteria for chronic hypertension in pregnancy).
- •Patients actively using any illicit substance or have history of substance use disorder.
- •Patients who are actively consuming alcohol during pregnancy.
- •Patients with Type I or Type II Diabetes Mellitus.
- •Patients with end stage renal disease.
- •Patients less then 12 weeks gestation or greater than 16 weeks
研究组 & 干预措施
Treatment Group
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
干预措施: Nifedipine (Drug)
Treatment Group
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
干预措施: Labetalol (Drug)
结局指标
主要结局
Treatment of elevated blood pressures
时间窗: through study completion, an average of 1 year
NICU days
次要结局
- ICG directed treatment(through study completion, an average of 1 year)
研究者
Jesse Cottrell
Assistant Professor of Maternal Fetal Medicine
Marshall University