Use of Angiogenic Factors in the Conservative Management of Gestational Hypertension. Prospective, Randomised, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Progression to preeclampsia
研究概览
简要总结
Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. One of the most controversial scenarios is gestational hypertension, a group of hypertensive disorders considered the mildest form of the pre-eclamptic spectrum, where current recommendations indicate termination of pregnancy at 37 weeks. However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known. The purpose of the study is to use angiogenic factors as a guide to decide the most appropriate gestational age for termination of pregnancy in patients diagnosed with gestational hypertension.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between 24 and 40 weeks of gestation.
- •Diagnosis of Gestational Hypertension based on ACOG criteria
- •index sFlt-1/PIGF equal or below 33
排除标准
- •Multiple gestation
- •Maternal vasculitis
- •Previous cesarean section (3 or more)
- •Neurological conditions
- •Chronic renal disease
- •Heart disease
- •Index sFlt-1/PIGF of 34 or more
结局指标
主要结局
Progression to preeclampsia
时间窗: From the moment of randomization up until delivery. Between 1 and 17 weeks.
In subject with gestational hypertension and sFlt-1/PIGF at enrollment equal or below 33, the appearance of proteinuria, severe criteria or sFlt-1/PIGF above 34
次要结局
- Maternal / fetal morbidity(Up until discharge. On average, 7 days)
- Neonatal morbidity(Up until discharge. On average, 3 days)
研究者
Osvaldo A. Reyes T.
Head of the research deparment
Saint Thomas Hospital, Panama
