Comparative study of Oxytocin 10 IU IM V/s Oral Misoprostol 600 MCG in active management of third stage of labour
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- 1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery and on day 2 post-delivery of two intervention groups.
研究概览
简要总结
This study is a randomized,parallel group prospective comparative study of Oxytocin 10 IU IM V/S Oral Misoprostol 600 mcg in active management of third stage of labour that will be conducted in India. The primary outcome is to measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haemotocrit after comparing these in both pre and post delivery of two intervention groups and also to assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage in two intervention groups. The secondary outcomes will be to ascertain the side effects of oxytocin and misoprostol in two intervention groups and also the need of blood transfusion..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with gestational age more than 28 weeks and at low risk , undergoing vaginal delivery.
- •Patients having the ability and willingness to provide an informed consent.
排除标准
- •Hb under 8gm
- •Previous pregnancy associated with PPH.
- •Patient with traumatic PPH due to genital laceration.
- •Antepartum haemorrhage.
- •Multiple pregnancies.
- •Non-cephalic presentation.
- •Multipara, big baby, fibroid uterus, polyhydramnios
- •Previous LSCS
- •Hypertension, pre-eclampsia or pregnancy induced hypertension.
- •Intra uterine death.
- •Seizures, diabetes, renal anomalies, cardiac arrest or coagulation disorders.
- •Choriamnionitis
- •Polyhydraminos.
- •Epidural anaesthesia.
- •Bronchial asthma or respiratory disorders.
结局指标
主要结局
1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery and on day 2 post-delivery of two intervention groups.
时间窗: 1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery-baseline and post-delivery at day 2 and on discharge of two intervention groups. | 2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage post delivery
2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage
时间窗: 1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery-baseline and post-delivery at day 2 and on discharge of two intervention groups. | 2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage post delivery
次要结局
- 1.To ascertain the side effects of the IM oxytocin & oral misoprostol(2. Need of blood transfusion)
研究者
Dr Shilpa Kshirsagar
Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune