A randomized trial to compare the effectiveness of oral nifedipine & intra-venous Hydralazine in acute hypertensive emergencies of pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time required to achieve target systolic BP of 150 mm of Hg or lower and diastolic BP of 100 mm of Hg or lower (both targets had to be fulfilled).
研究概览
简要总结
In this double blind randomized controlled trial sixty women (thirty in each group), with acute hypertensive emergency of pregnancy (defined as BP more than 160 systolic and or more than 110 diastolic) at more than 24 weeks of gestation, will be randomized to either receive intravenous hydralazine (dose 5 mg, 10 mg, 10 mg, 10 mg, repeated every 20 minutes to maximum 4 doses)or oral nifedipine (dose 10 mg each repeated after 20 minutes each to maximum of 4 doses) every 20 minutes till target BP is achieved (less than 150 systolic and 100 diastolic), after satisfying inclusion and exclusion criteria. Time required to achieve target BP, side effect profile and perinatal outcome will be observed in each woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age between 18 to 45 years, 2.Period of gestation > 24 weeks of gestation 3.Maternal Heart rate; 60-90 beats per minute 4.Reassuring fetal heart rate.
排除标准
- •1.known case of heart disease (pre-existing angina) 2.Non-pregnancy related hypertension (diagnosed cases of chronic or secondary hypertension) 3.Allergy to either of the drug 4.Need for any acute emergency for cesarean section (Abruptio placentae, severe fetal bradycardia etc).
结局指标
主要结局
Time required to achieve target systolic BP of 150 mm of Hg or lower and diastolic BP of 100 mm of Hg or lower (both targets had to be fulfilled).
时间窗: 2 hours after delivery
次要结局
- Total number of antihypertensive dosages required to achieve the target BP (systolic BP of 150 mm of Hg or lower and diastolic BP of 100 mm of Hg or lower, both to be fulfilled)(Maternal heart rate profile during the study period)