Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 453
- 试验地点
- 4
- 主要终点
- Rate of readmission and/or triage visits
研究概览
简要总结
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
详细描述
To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age ≥ 18 years and <50 years.
- •Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy, labor or postpartum.
- •defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or ^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.)
排除标准
- •Subject requiring antihypertensive therapy at time of screening.
- •Planned discharge with oral anti-hypertensive medication.
- •Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
- •Subject not able to follow up postpartum.
- •Lactose intolerance.
- •Pre-gestational diabetes.
研究组 & 干预措施
Placebo Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
干预措施: Placebo Tablet (Drug)
Hydrochlorothiazide 50mg Tablet
Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
干预措施: Hydrochlorothiazide 50mg Tablet (Drug)
结局指标
主要结局
Rate of readmission and/or triage visits
时间窗: 1-6 weeks postpartum
Any visit in the hospital
Need for additional antihypertensive therapy
时间窗: 1-6 weeks postpartum
Requiring additional antihypertensive agents in the postpartum period
次要结局
- Length of hospital stay(1-6 weeks postpartum)
- Adverse Events(1-6 weeks Postpartum)
- Total Additional doses of anti-hypertensive therapy(1-6 weeks postpartum)
- Severe composite maternal morbidity(1-6 weeks postpartum)
- Elevation of blood pressure >150/90(1-6 weeks postpartum)
- Use of resources(1-6 weeks postpartum)