PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Number of spontaneous delivery
研究概览
简要总结
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.
After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.
A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.
The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.
To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened 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
- Treatment
- 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
- 否
入选标准
- •Minimal age of 18 years
- •Informed consent
- •Confirmation of dating of pregnancy by first trimester echography.
- •Episode of threatened preterm labour
- •Singleton between 24 and 34 weeks of gestation
- •Cervical length ≤20mm in cervimetry
- •Pulmonary maturation completed
- •≤6 contractions by hour after 24 hours of tocolysis.
排除标准
- •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- •Spontaneous rupture of membranes at the time of randomization
- •Cervical cerclage in situ
- •Uterus malformations
- •Antecedent of conisation
- •Active vaginal bleeding, placenta previa
- •Intra-amniotic infection
- •Hydramnios
- •Maternal chronic pathology (hypertension, diabetes)
- •Anomaly of breathing foetal rate
结局指标
主要结局
Number of spontaneous delivery
时间窗: 37 weeks of gestation
Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.
次要结局
- Number of patients with increase of vaginal discharge(from date of randomization until the date of the delivery)
- Number of patients with neonatal morbidity(From date of delivery until 6 weeks after the date of term)
- Number of patients with spontaneous pessary ejection(from date of randomization until the date of the delivery)
- Number of spontaneous delivery(28 weeks of gestation)
- Number of admission for preterm labor(from date of randomization until the date of the delivery)
- Number of fetal-neonatal death(at delivery)
- Number of birth death(From date of delivery until 6 weeks after the date of term)
- Number of patients with discomfort(from date of randomization until the date of the delivery)
- number of day between resolutive threatened preterm labor and delivery(At delivery)