NCT02716922
Unknown
3 期
Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
Federico II University1 个研究点 分布在 1 个国家目标入组 300 人2016年3月
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Preterm Birth
- 发起方
- Federico II University
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Spontaneous preterm birth rates <34weeks
- 最后更新
- 10年前
概览
简要总结
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size
研究者
Gabriele Saccone
Medical Doctor
Federico II University
入排标准
入选标准
- •Singleton pregnancy (limits the participants to female gender)
- •Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
- •18-50 years of age
排除标准
- •Multiple gestation
- •Prior spontaneous preterm birth 16-36 6/7 weeks
- •Ruptured membranes
- •Lethal fetal structural anomaly
- •Fetal chromosomal abnormality
- •Pessary in place (or planned placement)
- •Vaginal bleeding
- •Suspicion of chorioamnionitis
- •Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
- •Painful regular uterine contractions
结局指标
主要结局
Spontaneous preterm birth rates <34weeks
时间窗: Less than 34 weeks gestation
次要结局
- Type of delivery(Time of delivery)
- intraventricular hemorrhage(Between birth and 28 days of age)
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Neonatal death(Between birth and 28 days of age)
- birth weight(Time of delivery)
- Chorioamnionitis(Time of delivery)
- perinatal death(Until 28 days of age)
- Spontaneous preterm birth rates <37, <28 and <24 weeks(Less than 24, 28, and 37 weeks gestation)
- necrotizing enterocolitis(Between birth and 28 days of age)
- respiratory distress syndrome(Between birth and 28 days of age)
- bronchopulmonary dysplasia(Between birth and 28 days of age)
- blood-culture proven sepsis(Between birth and 28 days of age)
- neonatal mortality(Between birth and 28 days of age)
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical LengthPreterm BirthNCT02746900Federico II University587
已完成
3 期
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm BirthPreterm BirthNCT02716909Federico II University300
招募中
不适用
Single Versus Double Suture Cervical Cerclage to Prevent Preterm BirthThe Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages PlacedNCT04742647Stony Brook University84
已完成
不适用
Cerclage vs Cervical Pessary in Women With Cervical IncompetenceCervical InsufficiencyNCT02405455Maternal-Infantil Vall d´Hebron Hospital60
招募中
不适用
Cervical cerclage to prevent preterm birth: a retrospective cohort studyCerclage during pregnancy to prevent preterm birthNL-OMON26969Máxima MC150