Präoperative Und Intraoperative Sonografische Beurteilung Des Unteren Uterinsegmentes im Rahmen Der Re-Sectio Caesarea - Eine Ultraschall- Methoden-Vergleichsstudie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
研究概览
简要总结
This prospective, clinical, observational study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
详细描述
In 1991, 126.297 (15.3%) women delivered by caesarean section in Germany. Since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011 [https://www.destatis.de\]. The absolute risk of uterine rupture in vaginal birth after Caesarean section is 1 in 100 deliveries. The risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries [Cunningham et al., 2009].
Statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the C-section scar before delivery. They have one important question: Is it possible to predict successful trial of labor after cesarean delivery? [AQUA-Institut] The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment [Varner et al., 2012].
The measurement technique for lower uterine segment (myometrial) thicknesses in the third trimester have been described by several authors. Using a combination of preoperative transvaginal and transabdominal (linear/convex probe) ultrasound, we compare with intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.
The aim of the present study is to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.
This will allow the investigators to draw conclusions regarding the best method to assessment of lower uterine segment (myometrial) thickness in the third trimester to predict successful trial of labor after cesarean delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •pregnancy after previous cesarean section
- •pregnancy between 37 0/7 and 42 0/7 weeks of gestation
- •primary or secondary indication for cesarean section
- •ability to give informed consent in german or english
排除标准
- •emergency caesarean section
- •<18 years old
结局指标
主要结局
Difference between preoperative and intraoperative sonographic assessment of lower uterine segment I
时间窗: intraoperative - just bevore the uterotomy
Bland-Altman-Plot (mean versus difference) of Method A) Preoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with transabdominal (linear ultrasound probe) and with transvaginal sonography (vaginal ultrasound probe) with the lowest value (thinnest area) being retained AND Method B) Intraoperative measurement of minimum myometrium-only thickness overlying the amniotic cavity at the level of the lower uterine segment scar - measured with intraoperative sonography after preparation of lower uterine segment (linear ultrasound probe)
次要结局
- Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIA(intraoperative - just bevore the uterotomy)
- Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIB(intraoperative - just bevore the uterotomy)
- Difference between preoperative and intraoperative sonographic assessment of lower uterine segment IIC(intraoperative - just bevore the uterotomy)
研究者
Gregor Seliger
Dr. med., chief resident
Martin-Luther-Universität Halle-Wittenberg