Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- cervical length ≤ 25 mm.
研究概览
简要总结
Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor
详细描述
Pregnant women with twin gestations are screened for short cervix with transvaginal cervical length measurements as part of routine care at St. Mary's Health Center (SMHC) and Saint Louis University's (SLUCare) Physician Group. (Transvaginal cervical length measurement every 2 weeks from 16weeks/0days-23weeks/6days weeks, per hospital practice) Women pregnant with twin gestations at SMHC who meet study criteria will undergo transvaginal length screening between 16 and 24 weeks gestation. Those women with transvaginal cervical length measurements at or below 25 mm will be approached for study participation.
If a patient agrees to participate in the trial, they will be randomized in 1:1 fashion to cerclage vs. expectant management.
Participants found to have a vaginal infection by cultures performed at randomization will be treated with appropriate antibiotics per usual institutional practices
Cerclage arm:
- Macdonald cerclage placed in standard fashion: mersilene suture preferred for standardization
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
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 14 years of age, but less than 55 yrs of age
- •must be able to read and write English
- •must be able to give informed consent.
- •Twin pregnancy
排除标准
- •Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study
- •membrane prolapse beyond the external cervical os,
- •major fetal anomaly in either twins will be excluded from randomization.
研究组 & 干预措施
Cerclage
- Macdonald cerclage placed in standard fashion
干预措施: Cerclage (Procedure)
Expectant management
- Patient is placed on activity restrictions
干预措施: Expectant management (Other)
结局指标
主要结局
cervical length ≤ 25 mm.
时间窗: 1 year
To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation.
次要结局
- cervical length ≤ 15 mm.(1 year)
研究者
Laura Vricella, MD
Assistant Professor
St. Louis University