跳至主要内容
临床试验/NCT05334264
NCT05334264招募中不适用

The Value of Prophylactic Cervical Cerclage Against Preterm Birth in Twin Pregnancies With History of Preterm Birth and Non-shortened Cervix: A Randomized Controlled Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
2
主要终点
The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks.

研究概览

简要总结

This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

详细描述

Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant deaths.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births5, Fuchs and Senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of PTB. This conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 Available meta-analytic data remained of limited value in view of the few and small clinical studies that were included.

Although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the US Standard Certificate of Live Birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 Some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18-50 years.
  • Dichorionic twins.
  • History of ≥1 preterm birth.
  • Transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age.
  • Asymptomatic.

排除标准

  • Triplets and quadruplets.
  • Monochorionic twins.
  • Threatened/ inevitable miscarriage
  • Bulging membranes through the external os.
  • Extremes of age.
  • Major fetal anomalies.
  • Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc.
  • Fetal demise.
  • Fetal reduction in the current pregnancy.

结局指标

主要结局

The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks.

时间窗: immediately after delivery for study cases through study completion, an average of 1 year

Number of preterm deliveries stratified according to gestational age groups mentioned

次要结局

  • The incidence of miscarriage.(immediately after occurrence of miscarriage through study completion, an average of 1 year)
  • Incidences of bad Neonatal outcomes in both groups(during early neonatal follow up through study completion, an average of 1 year)
  • Incidence of cervico-vaginal infection(once reported or confirmed during pregnancy through study completion, an average of 1 year)

研究者

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

Hytham Atia

Associate professor

Zagazig University

研究点 (2)

Loading locations...

相似试验

Prophylactic Cervical Cerclage in Twin Pregnancies... | 临床试验