Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Composite maternal adverse outcome
研究概览
简要总结
This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.
详细描述
The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients scheduled for a cesarean section
- •term pregnancy: 37-42 weeks
- •singleton pregnancy
- •age 18 and above
- •patients capable of signing an informed consent
排除标准
- •multiple pregnancy
- •emergency cesarean
- •previous 3 cesareans and above
- •placenta accreta
- •uterine myomas in the lower segment
- •fetal growth restriction
- •fetal anemia
- •preeclampsia
- •women scheduled for general anesthesia
研究组 & 干预措施
FAUCS
Patients undergoing a cesarean section using the FAUCS technique
干预措施: French Abulatory Cesrean Section (Procedure)
Control
Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
干预措施: Misgav-Ladach (Procedure)
结局指标
主要结局
Composite maternal adverse outcome
时间窗: 24 hours post surgery
The rate of women with a composite maternal adverse outcome, defined as at least one of the following: Visual Analogue Scale score \>6 (scale of 1-10, 1 being a very mild pain, 10 being the worst pain imagineable) at 3-4 hours post surgery, inability to ambulate 3-4 hours post surgery, and QoR15 (Quality of Recovery) score \< 90 (range 0 to 150, 150 being the best recovery after surgery) at 24 hours post surgery
次要结局
- Length of surgery(24 hours)
- Birthweight(immediately after birth)
- Cord pH(immediately after birth)
- Birth trauma(24 hours)
- Blood loss (ml) during surgery(24 hours)