The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Hemoglobin level after delivery
研究概览
简要总结
Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome.
Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.
The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding.
During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period.
Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding.
The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Estimated to be appropriate for gestational age fetus.
- •Sonographic dating before 20 weeks of gestation.
排除标准
- •Non-scheduled CD.
- •Major fetal malformations.
- •Multiple gestations.
- •Non-controlled diabetes.
- •Severe pre-eclampsia.
- •General anesthesia.
- •HIV carrier
- •Neonatal need for early resuscitation.
研究组 & 干预措施
Natural cesarean delivery
Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery.
干预措施: Natural cesarean delivery (Other)
Standard cesarean delivery
Presentation of the neonate to the mother during the operation.
干预措施: Standard cesarean delivery (Other)
结局指标
主要结局
Hemoglobin level after delivery
时间窗: 4 days
Difference between pre- and post-surgical hemoglobin levels.
次要结局
- Pain score during the operation(1 hour)
- Neonatal temperature after delivery(1 hour)
- Breast engorgement(4 days)
- Analgesia use during the operation(1 hour)
- Blood product transfusion(4 days)
- Pain score during the first day after cesarean delivery(24 hours)
- Rate of breastfeeding at maternal hospital discharge(4 days)
- Rate of breastfeeding 6 months after delivery(6 months)
- Maternal satisfaction of the delivery(4 days)
- Analgesia use during the first day after cesarean delivery(24 hours)
研究者
Raed Salim
Head of delivery unit
HaEmek Medical Center, Israel