Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 309
- 试验地点
- 8
- 主要终点
- Wound Complications
研究概览
简要总结
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pre-pregnancy BMI equal or greater than 40
排除标准
- •prior cesarean section or laparotomy
结局指标
主要结局
Wound Complications
时间窗: 6 months
次要结局
未报告次要终点
研究者
Peter R Cole, MD
Chief, Divison of Gynecology, Department of OBGYN
Albany Medical College
