NCT05501938Unknown不适用
Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Preterm Delivery Rate
研究概览
简要总结
RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women 18 years of age or older
- •Nulliparous patient, has not had a preterm to term delivery
- •Singleton pregnancy
- •English or Spanish speaking
- •Asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation
排除标准
- •Twin or higher order multi-fetal gestation
- •Multiparous patient, has had one or more preterm to term deliveries
- •Cervical dilation more than 2 cm either at the beginning of the study or any time during the study
- •Amniotic membranes prolapsed beyond the external os
- •Fetal reduction procedure performed during current pregnancy
- •Ruptured membranes prior to randomization
- •Major fetal structural anomaly
- •Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing
- •Cerclage already in place for other indication
- •Active vaginal bleeding
- •Suspicion of chorioamnionitis
- •Placenta previa
- •Painful regular uterine contractions
- •History of preterm birth before 37 weeks gestation
- •Non-English or non-Spanish speaking
- •a. Given that the study is explained in person and consent forms are written in English, there is no guarantee that the study will be explained correctly when using a phone translator. The same is true if the current English consent form were to be translated into a language other than English. There is no way to confirm that the integrity of the study is being upheld by using translating services. If the integrity of the study is not upheld, then this poses harm to the patient.
- •Women under 18 years of age
结局指标
主要结局
Preterm Delivery Rate
时间窗: 1 Year
Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period
次要结局
- Neonatal Outcomes(1 Year)
研究者
Craig Zelig
Director of Maternal Fetal Medicine; MFM Fellowship Director
Albany Medical College
研究点 (2)
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