Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Presence/absence of fetal blood in maternal circulation
研究概览
简要总结
Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would reduce the incidence of feto-maternal transfusion. Patients were randomized to placental drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal transfusion was noted postoperatively.
详细描述
86 patients were randomized to placental drainage vs. no drainage of fetal blood at the time of cesarean section. Kleihauer-Betke testing was performed within 12 hours postoperatively to assess the incidence of feto-maternal transfusion. A significant difference was found between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women undergoing cesarean section
排除标准
- •Preoperative Kleihauer-Betke, known antepartum erythrocyte sensitization, overt vaginal bleeding, history of a previous delivery by low vertical cesarean section, prolonged rupture of membranes, twin gestation, failure to obtain both preoperative and postoperative Kleihauer-Betke tests.
研究组 & 干预措施
no drainage of fetal blood
placental drainage
干预措施: drainage of placenta of fetal blood (Procedure)
结局指标
主要结局
Presence/absence of fetal blood in maternal circulation
时间窗: within 12 hours postoperatively
次要结局
- no secondary outcome measures(end of study)