CTRI/2011/10/002064尚未招募不适用
Effect of mid trimester yoga on the incidence of Preeclampsia in high risk women
K Manikandan1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Occurrence of Gestational Hypertension/Preeclampsia
研究概览
简要总结
| Background: Preeclampsia is a potentially life threatening complication of pregnancy. In JIPMER, the number of preeclamptic women in 2009 was 2015.In the past several attempts to prevent this disastrous complication have yielded little success. Although the exact etiopathogenesis of the disease is still elusive, the central pathology is global vasospasm. Outside of pregnancy, yoga has been shown to decrease both systolic and diastolic blood pressure in essential hypertension, a disease with similar pathology. Yoga has also been shown to decrease the stress levels which may contribute to the pathogenesis of vascular spasm. Yoga is safe in pregnancy as has been shown by numerous studies of the effect of yoga on labor and birth. Yoga in pregnancy has also been shown to have a significant beneficial effect on fetal growth.There are no studies specifically addressing the issue of preventive effect of yoga on pregnancy induced hypertension. |
Hypothesis: Yoga, when practiced in mid pregnancy decreases the incidence of preeclampsia in high risk women
| Objectives |
(a) Overall
(b) Specific
To assess the effect of Yoga in Preeclampsia Prevention
1. To assess the effect of yoga in mid pregnancy on the occurrence of preeclampsia in women at high risk of developing preeclampsia
- To assess the effect of yoga on the maternal and perinatal outcome in women at high risk of developing preeclampsia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women who present at gestational age less than 16 weeks and having any of the following high risk attributes:
- •Chronic hypertension: [defined as blood pressure equal to or more than 140/90 detected prepregnancy or before 20 weeks of gestation]
- •Gestational hypertension/Preeclampsia/Eclampsia in any previous pregnancy
- •History of abruption or unexplained IUGR in any previous pregnancy 4.First trimester uterine artery PI more than the 90th centile [using the Fetal Medicine Foundation calculator].
排除标准
- •Patients with musculoskeletal disorders or defects preventing satisfactory performance of yoga techniques
- •Women with cardiac/chronic pulmonary disease preventing satisfactory performance of yoga techniques.
结局指标
主要结局
Occurrence of Gestational Hypertension/Preeclampsia
时间窗: discharge from hospital after delivery
次要结局
- Onset of Gestational Hypertension-Preeclampsia(discharge from hospital after delivery)
- Severity of Preeclampsia(discharge from hospital after delivery)
- Gestational Length(delivery)
- Maternal Mortality(hospital stay)
- Neonatal Intensive Care Unit admission(Discharge from hospital after delivery)
- Neonatal Mortality(Discharge from hospital after delivery)
- fetal growth restriction(nil)
研究者
研究点 (1)
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