Is the Cerclage Area Associated With the Incidence of Preterm Birth in Pregnant Women Undergoing Mc Donald Cerclage?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- cervical cerclage area
研究概览
简要总结
This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.
详细描述
The parameters that will be measured with transvaginal ultrasound are:
- Cerclage area in the axial plane of the cervix
- Angle between anterior uterine wall and internal os
- Angle between anterior uterine wall and external os
- Anterior and posterior cervical widht at level of stitch
- Anterior and posterior stitch depth (stitch to canal )
- Cervical length above and below cerclage stitch
Before the data collection phase ,the required sample number for the research was determined using the G*power (Faul, Erdfelder, Buchner, & Lang, 2009) 3.1 program. When the alpha level is .05 and the power is %95 , the total number of samples was found o be 22.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy between 16-23 weeks of gestation and between the ages of 18-45
- •According to ACOG based on history (Having one or more painless abortions between 16-22 weeks of gestation , a history of cerclage
- •According to ACOG based on physical examination ( fetal membranes prolapsed from endocervical canal or not, cervical dilation present )
- •Accoding to ACOG based on ultrasound examination ( if there is no previous history of preterm birth , if the cervical length is 10mm or less, if the cervical length is less than 25mm with a history of preterm birth )
排除标准
- •Multiple pregnancies
- •Pregnant women with premature rupture of membranes
- •Pregnant women with uterine anomalies
- •Pregnant women with fetal anomalies
- •Pregnant women with Gestational diabetes mellitus, Chronic or gestational hypertension , fetal growth restriction , oligohydroamnios or polihydroamnios
结局指标
主要结局
cervical cerclage area
时间窗: Between 16-23 weeks of pregnancy
cervical cerclage will be measured in the axial plane of the cervix by transvaginal ultrasonography
Preterm birth
时间窗: From date of cervical cerclage to delivery
The incidence of patients delivered before 37. gestational weeks
次要结局
未报告次要终点
研究者
Neval Cayonu
Research fellow in perinatology
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital