Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Mean duration time between incision and fetal head delivery
研究概览
简要总结
The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.
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
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.
排除标准
- •Elective cesarean
研究组 & 干预措施
routine manual maneuvers for fetal head extraction
Procedure/Surgery:
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
干预措施: routine manual maneuvers for fetal head extraction (Procedure)
vacuum
Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head. He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers).
干预措施: vacuum (Procedure)
结局指标
主要结局
Mean duration time between incision and fetal head delivery
时间窗: during surgery
In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).
次要结局
- fetal complications(after extraction of fetus and during cleaning of fetus under warmer)
研究者
Behnam Baghianimoghadam
shahid sadoughi university of medical sciences and health services, Yazd, Iran
Shahid Sadoughi University of Medical Sciences and Health Services