Effect of History-indicated Early Treatment With Cervical Pessary Versus Expectant Management Treatment With Rescue Cerclage in Cases With Cervical Shortening in Singleton Pregnancies at High-risk for sPTB on Children's Long-term Outcome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 试验地点
- 15
- 主要终点
- Children's survival without neurodevelopmental disability at the age of 3 years
研究概览
简要总结
Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well.
The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity < 34 week of gestation (WoG).
The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.
详细描述
The "Prometheus Trial" is a prospective, multicentre, multinational, open-label, randomised, controlled clinical trial in parallel groups.
Up to now the risk factor previous PTB has only been investigated in randomised controlled trials (RCTs) for 17-hydroxyprogesterone caproate (17-OHPC) which is not available in most european countries or in RCTs where the risk factor previous PTB was combined with the risk factor cervical shortening.
Looking at the evidence of therapeutic effectiveness of vaginal progesterone these risk factors should be addressed separately. Vaginal progesterone proved to be ineffective in the prevention of recurrent PTB but effectively reduced PTB in women with a short cervix.
For cervical pessary therapy there is up to now only one cohort analysis for the combined risk factors available proving the placement of a cervical pessary to be as effective as cerclage or treatment with 200 mg vaginal progesterone in reducing preterm birth rate.
The risk factor 'history of at least one cold knife conisation' for PTB was up to now only addressed in a pilot study investigating the effect of pessary treatment in asymptomatic women with a singleton pregnancy along with a short sonographic cervix and it suggested a beneficial effect on the prolongation of the pregnancy.
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
盲法说明
due to the nature of the intervention (placement of a cervical pessary) a masking is not possible
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a singleton pregnancy and a history of at least one previous preterm delivery before 34+0 weeks and/or a history of at least one previous cervical surgery
- •12+0 - 16+0 weeks of gestation at time of randomization
- •only women with minimum age of 18 and capable of giving consent
排除标准
- •major fetal abnormalities
- •uterine malformation, placenta previa totalis
- •Cerclage prior to randomization
- •At randomisation: active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular uterine contractions
- •silicone allergy
- •current participation in other RCT
结局指标
主要结局
Children's survival without neurodevelopmental disability at the age of 3 years
时间窗: assessment of the newborn at age of 3 years (corrected age for prematurity)
* mortality rate will be recorded * neurodevelopmental disability will be assessed by the Ages \& Stages questionnaire and by medical examination at 3 years of age (corrected age for prematurity)
次要结局
- rate of preterm birth(randomisation till birth, maximum 25 weeks)
- time till birth(days from randomisation till birth, maximum 30 weeks)
- birth weight of the neonate(at birth)
- Need (days) for neonatal special care unit(birth till discharge from hospital, recorded for at least first 48 hrs after birth)
- Fetal or neonatal death(at birth, first 24 hours after birth)
- harm from intervention(birth till discharge from hospital, recorded for at least first 48 hrs after birth)
- premature rupture of membranes (PRoM) before 31+6 weeks(randomization till birth, maximum 20 weeks)
- maternal death(enrollment till discharge from hospital, recorded for at least first 48 hrs after birth)
- neonatal morbidity(birth till discharge from hospital, recorded for at least first 48 hrs after birth)
- infection/inflammation(enrollment till discharge from hospital, recorded for at least first 48 hrs after birth)
- physical or psychological intolerance to pessary(time from placement of cervical pessary at enrollment till removal of cervical pessary at WoG 37, maximum 25 weeks)
- rate of significant maternal adverse events(enrollment till discharge from hospital, recorded for at least first 48 hrs after birth)
- Hospitalisation for threatened preterm labour before 31+6 weeks(randomization till birth, maximum 20 weeks)
研究者
Ioannis Kyvernitakis
Associate Professor
Bürgerhospital Frankfurt