跳至主要内容
临床试验/NCT02685761
NCT02685761Unknown不适用

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

Albany Medical College6 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
309
试验地点
6
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

研究组 & 干预措施

Low Transverse

No Intervention

Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location

Midline Vertical

Experimental

Patients in this arm will undergo their cesarean section using a midline vertical skin incision

干预措施: Midline Vertical (Procedure)

High Transverse

Experimental

Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus

干预措施: High Transverse (Procedure)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter R Cole, MD

Chief, Divison of Gynecology, Department of OBGYN

Albany Medical College

研究点 (6)

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