Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 329
- 试验地点
- 3
- 主要终点
- Incidence of preterm birth <37 weeks
研究概览
简要总结
The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
详细描述
Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth <37 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •18-50 years old, pregnant, assigned female at birth
- •Singleton pregnancy
- •TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
排除标准
- •Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed >14 weeks, or cotwin pregnancy loss diagnosed >14 weeks
- •Cerclage in situ
- •Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
- •Active vaginal bleeding
- •Suspected intraamniotic infection
- •Major fetal structural abnormality or chromosomal disorder
- •Placenta previa or accreta
- •Other contraindication to cerclage placement
- •Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone
研究组 & 干预措施
Control
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
干预措施: Vaginal Suppository Progesterone (Drug)
Cerclage
Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
干预措施: Cervical cerclage (Procedure)
Cerclage
Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
干预措施: Vaginal Suppository Progesterone (Drug)
结局指标
主要结局
Incidence of preterm birth <37 weeks
时间窗: At delivery
次要结局
- Time interval from randomization to delivery(At delivery)
- Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks(At delivery)
- Gestational age at delivery(At delivery)
- Incidence of preterm prelabor rupture of membranes (PPROM)(At occurrence up to 36 weeks and 6 days of gestation)
- Incidence of intraamniotic infection(At the time of delivery at any gestational age)
- Neonatal outcomes: incidence of low birthweight (<2500g)(At delivery)
- Neonatal outcomes: incidence of very low birthweight (<1500g)(At delivery)
- Neonatal outcomes: incidence of admission to neonatal intensive care unit(At delivery)
- Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality(At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality)