Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Pre-term Birth
研究概览
简要总结
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.
Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os.
The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestations
- •Diagnosis of arrested PTL
- •18-50 years of age
- •TVU CL ≤25mm at the time of randomization
排除标准
- •Multiple gestations
- •Rupture of membranes at the time of randomization
- •Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- •Fetal death at the time of randomization
- •Cerclage in situ at the time of randomization
- •Pessary in situ at the time of randomization
- •Vaginal bleeding at the time of randomization
- •Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years
- •Placenta previa and/or accreta
- •Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization
- •Painful and regular uterine contractions at the time of randomization
结局指标
主要结局
Pre-term Birth
时间窗: at the time of delivery
delivery before 37 weeks of gestations
次要结局
- Mean latency in days(at the time of delivery)
- Pre-term Birth <34, <32, and <28 weeks(at the time of delivery)
- Mean gestational age at delivery in weeks(at the time of delivery)
- Maternal side effects related to the intervention(at the time of delivery)
- Chorioamnionitis(at the time of delivery)
- Composite adverse perinatal outcome(Between birth and 28 days of ag)
研究者
Gabriele Saccone
Principal Investigator
Federico II University