Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
研究概览
简要总结
This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.
详细描述
Introduction 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 mortality.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 births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
Rationale:
Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18-45 years.
- •Dichorionic twins.
- •Transvaginal sonographic cervical length is <25 mm with or without internal os dilatation ≥10 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 ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
时间窗: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Rate of preterm births stratified by gestational age inside the included women
次要结局
- Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm(Immediate reporting of cases at time of delivery through study completion, an average of 1 year)
- Incidence of cervico-vaginal infection(after confirmation of infection through study completion, an average of 1 year)
- The incidence of miscarriage.(Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year)
- Neonatal outcomes in both groups(early neonatal through study completion, an average of 1 year)
研究者
Hytham Atia
Associate professor
Zagazig University