Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 894
- 试验地点
- 2
- 主要终点
- Successful outcome
研究概览
简要总结
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
详细描述
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant gestational age >= 28 weeks
- •Systolic blood pressure >=160 mm Hg OR a diastolic blood pressure of >=110 mm Hg measured twice more than 15 minutes apart
- •Able to swallow pills
- •>= 18 years
排除标准
- •Indication for emergent cesarean or known fetal anomaly
- •Anti-hypertensive therapy received in the past 12 hours
- •History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy
- •Actively wheezing at time of enrollment or history of asthma complications
- •Known coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta
研究组 & 干预措施
Nifedipine
Women will receive an initial dose of oral nifedipine 10mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 10mg dose can be provided each hour for two additional doses (30 mg total).
干预措施: Nifedipine (Drug)
Methyldopa
Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given.
干预措施: Methyldopa (Drug)
Labetalol
Women will receive an initial dose of oral labetalol 200mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 200mg dose can be provided each hour for two additional doses (600 mg total).
干预措施: Labetalol (Drug)
结局指标
主要结局
Successful outcome
时间窗: 6 hours
Successful outcome will be considered blood pressure that reaches the target (defined as 120-150mmHg systolic and 70-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.
次要结局
- number of hourly BP's in severe range(one hour)