Role of maternal cardiovascular markers in predicting adverse outcomes in women with Pre eclampsia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Maternal core outcomes
研究概览
简要总结
This study aims to find out role of maternal cardiovascular markers in predicting Preeclampsia and hence to develop a multiparametric model using clinical, biochemical, placental, maternal cardiovascular markers in predicting preeclampsia early.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women admitted with diagnosis of PE at gestational age lesser than or equal to 34 weeks according to ISSHP criteria
- •Willing to be part pf study.
排除标准
- •Presence of fetal chromosomal or structural abnormality
- •Maternal cardiac disease
- •Hematological disorders
- •Multifetal gestation
- •Pre existing chronic hyertension.
结局指标
主要结局
Maternal core outcomes
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
A) Clinical parameters
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
1. Maternal mortality
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
2. Eclampsia
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
3. Stroke
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
4. Cortical blindness
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
5. Retinal detachment
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
6. Pulmonary edema
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
7. Acute kidney injury
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
8. Liver capsule hematoma or rupture
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
9. Placental abruption
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
10. Post partum haemorrhage
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
11. Admission to Intensive care unit requiring intubation or mechanical ventilation (not for childbirth)
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
Perinatal outcomes
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
1. Stillbirth
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
2. Gestational age at delivery
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
3. Birthweight
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
4. Small for gestational age
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
5. Neonatal mortality
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
6. Neonatal seizures
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
7. Admission to Neonatal unit required
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
8. Respiratory support required
时间窗: Following initial assessment patient will be followed up and managed according to institutional protocol till 7 days postpartum
次要结局
- 1. Predictive ability of FullPIERS model for adverse maternal and perinatal outcomes in women with Pre eclampsia(2. Predictive ability of sFLT/PlGF ratio with or without uterine artery doppler for adverse maternal and perinatal outcomes in women with Pre eclampsia)
研究者
Dr K Aparna Sharma
AIIMS New Delhi