Effect of timing of oxytocin administration in third stage of labor
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
A total of 208 patients with defined inclusion criteria above will be randomly allocated in to two groups of 104 patients each using computer generated random number table and the allocated number will be secured in a coded opaque sealed envelope.
The patient will be allocated in one of following two groups.
Group A (N=104): patient will be given injection oxytocin 10 units IM within 15 secs of delivery followed by delayed cord clamping.8
Group B (N=104): Patient will be given injection oxytocin 10 units IM at 3 minutes of delayed cord clamping.8
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •The following women undergoing vaginal birth will be eligible for enrollment in the study: Gestation greater than 35 weeks of gestation Singleton gestation Last Hb during pregnancy more than 8.0 gm/dl.
排除标准
- •Pregnant women with coagulopathy and bleeding disorder Pregnant women with APH (Placenta previa, placental abruption, uterine rupture and vasa previa) Fetal distress Severe FGR (fetal growth retardation.
结局指标
主要结局
Primary outcome
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Maternal mean blood loss during delivery at 0
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Neonatal outcome
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Birth weight within 5 minutes
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Apgar score within 5 minutes
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Need for phototherapy after delivery
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Neonatal intensive care unit admission
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
Packed cell volume in neonate at 6+2 hours of age will be done
时间窗: Primary outcome | Maternal mean blood loss during delivery at 0 | Neonatal outcome | Birth weight within 5 minutes | Apgar score within 5 minutes | Need for phototherapy after delivery | Neonatal intensive care unit admission | Packed cell volume in neonate at 6+2 hours of age will be done
次要结局
- Neonatal outcome(Birth weight)
研究者
SHIKHA RANI
Government Medical college Chandigarh