Randomized Controlled Trial of Uterine Exteriorization Versus in Situ Repair for Elective Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Incidence of intraoperative nausea and vomiting
研究概览
简要总结
This study is designed to compare the exteriorization of the uterus versus the in situ repair for closure of the hysterotomy incision with a completely standardized anesthetic protocol.
详细描述
Two well-known uterine repair techniques are described; the uterus can be repaired in situ within the peritoneal cavity (intraabdominal) or exteriorized temporarily from the abdomen for the closure of the hysterotomy incision (extraabdominal). 3 meta-analysis on the topic were unable to demonstrate the superiority of one technique regarding maternal morbidities. However, there is a paucity of studies with a standardized anesthetic protocol evaluating these outcomes.
This study will evaluate the impact of the uterine repair technique on different maternal morbidities; focusing on intra-operative nausea and vomiting under a standardized anesthetic protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, 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
- •Elective cesarean delivery
- •Term gestation, 37 weeks or more
- •Healthy parturients (ASA 1 and 2)
- •Spinal anesthesia
排除标准
- •Conditions at risk of uterine atony and/or postpartum hemorrhage (multiple gestation, placenta accrete / previa, pre-eclampsia / eclampsia, uterine leiomyomata, polyhydramnios)
- •Morbid obesity (BMI > 35 kg / m2) at delivery
- •Coagulopathy
- •Active labor
- •Cardiomyopathy
- •Emergency cesarean section
- •Refusal/Inability to consent
- •Language other than English or French
研究组 & 干预措施
In situ uterine repair
The uterus is repaired in situ within the abdominal cavity, without exteriorization; intra-abdominal repair
干预措施: Type A of uterine repair: In situ (Procedure)
Exteriorization of the uterus
The uterine incision is repaired with the exteriorization of the uterus; extra-abdominal repair
干预措施: Type B of uterine repair: Exteriorization (Procedure)
结局指标
主要结局
Incidence of intraoperative nausea and vomiting
时间窗: Intraoperative
Incidence of intraoperative nausea and vomiting using a scale of 0 to 3; 0 being no nausea, 1 being light nausea, 2 being severe nausea, and 3 being nausea accompanied with vomiting and / or retching. The patients will be questioned at 5 pre-determined time points during the cesarean delivery.
次要结局
- Length of surgery(Intraoperative)
- Incidence of hypotension(Intraoperative)
- Reduction in hemoglobin(Within 24 hours of surgery)
- Pelvic irrigation(Intraoperative)
- Estimated blood loss(Intraoperative)
- Incidence of endometritis(Through study completion; on average of 1 year)
- Time to return of bowel function(Up to 2 weeks)
- Length of hospital stay after the cesarean delivery(Through study completion on average of 1 year)
- Incidence of tachycardia(Intraoperative)
研究者
Valerie Zaphiratos
Clinical associate professor
Maisonneuve-Rosemont Hospital