Oral Rehydration Solution Versus Conventional Intravenous Hydration In Management Of Active Phase Of Labor In Low Risk Singleton Term Pregnancies A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- With this study we expect to prove that giving oral hydration through low osmolar ORS is more physiological way of approach to the women who are in active stage of labour because it will not restrict her ambulation, it will also keep her well hydrated during labour and there is less chance of any complication cause due to intravenous fluid.
研究概览
简要总结
Oral rehydration solution is widely used on different clinical conditions and it is very safe. If use of oral rehydration solution ORS is equally effective compared to conventional IV hydration in active labour so far the maternal and fetal outcome is concerned then it will be highly beneficial to use ORS because of its simplicity safety and acceptability in wider scale. Our preliminary experience also suggests its benefits. Therefore the research hypothesis of this study is oral rehydration solution in active phase of labour is going to be beneficial when compared with conventional intravenous hydration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 32.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnancy, term (37-41 weeks) gestation (37-41 weeks), low-risk status.
排除标准
- •High-risk pregnancies, including those with pre-existing medical conditions, previous caesarean delivery, or pregnancies requiring induction of labour.
结局指标
主要结局
With this study we expect to prove that giving oral hydration through low osmolar ORS is more physiological way of approach to the women who are in active stage of labour because it will not restrict her ambulation, it will also keep her well hydrated during labour and there is less chance of any complication cause due to intravenous fluid.
时间窗: Each laboring women will be assessed (at recruitment i.e, Baseline; then, every 4 hours during labor till delivery and day | 1, day 2 (postpartum period) for all women having vaginal delivery or caesarean section and at the time of discharge from hospital. | Newborns are assessed at birth , every 4 hours till 24 hours and then daily(day 1, day 2, D3...... and till discharge).
次要结局
未报告次要终点
研究者
Pooja
IPGMER SSKMH KOLKATA