Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemoglobin Drop
研究概览
简要总结
Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.
详细描述
Women undergoing spontaneous vaginal delivery at term with epidural analgesia will be randomly assigned to one of two groups: (1) manual removal of the placenta 15 minutes after delivery or (2) expectant management for 30 minutes, followed by manual removal of the placenta if it has not been delivered.
Both groups will receive active management of the third stage of labor, including oxytocin administration. Participants who develop active bleeding will undergo immediate manual removal of the placenta according to standard clinical care. Manual removal will be performed under epidural analgesia, and prophylactic antibiotics will be administered.
The primary outcome will be the difference in postpartum hemoglobin reduction between the two groups. Secondary outcomes will include incidence of blood transfusion, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term spontaneous vaginal delivery.
- •Singleton Pregnancy.
- •Epidural Analgesia during delivery.
- •Age between 18 and 45 years.
排除标准
- •Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.
- •Vacuum Extraction.
- •Intrapartum Infection.
- •Intrapartum fever above 38 degrees celsius.
- •Wide 3rd and 4th degree perineal tears that mandate suturing under general anaesthesia.
- •Thalassemia Carriers.
研究组 & 干预措施
Manual lysis after 30 minutes (Control)
Waiting 30 minutes after delivery and then manual lysis of the placenta.
干预措施: Manual Lysis of Placenta after 30 minutes (Control) (Procedure)
Manual Lysis after 15 minutes (Intervention)
Manual Lysis of Placenta 15 minutes after Delivery.
干预措施: Manual Lysis of Placenta after 15 minutes (Intervention) (Procedure)
结局指标
主要结局
Hemoglobin Drop
时间窗: within 24 hours after delivery
The difference between Hemoglobin levels before and after delivery
次要结局
- Febrile morbidity(within one week of delivery)
- Rate of Blood Products Given(7 days)
- Blood Loss(7 days)
- First Nursing(7 days)
- Hospital Stay(7 days)
- Maternal Satisfaction(7 days)
- Hemoglobin Drop(up to 6 weeks postpartum)
研究者
Raed Salim, MD
Professor
Holy Family Hospital, Nazareth, Israel