Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- number of uterine Cesarean section scars using transvaginal ultrasound
研究概览
简要总结
This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound.
It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.
详细描述
The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011.
Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture.
The risk of those complications increases further with the uterine scar tissue of a second Cesarean section.
Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery.
In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 否
入选标准
- •18 years or older
- •primary or secondary indication for cesarean section 6 to 9 months prior to the examination date
排除标准
- •<18 years old
- •current pregnancy
- •congenital deformity of the uterus
- •former surgery of the uterine myometrium
研究组 & 干预措施
1 cesarean section
control group
2 cesarean sections
control group
resection of uterine scar tissue
2 cesarean sections with resection of uterine scar tissue from first cesarean section
干预措施: resection of uterine scar tissue (Procedure)
结局指标
主要结局
number of uterine Cesarean section scars using transvaginal ultrasound
时间窗: 6-9 months
次要结局
- median myometrial thickness of lower uterine segment using transvaginal ultrasound(6-9months)
研究者
Gregor Seliger
Dr. med., chief resident
Martin-Luther-Universität Halle-Wittenberg