Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation: The PECEP Laser Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 352
- 试验地点
- 4
- 主要终点
- Delivery before 32 weeks
研究概览
简要总结
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.
详细描述
Monochorionic (MC) twin pregnancies present with a high rate of fetal complications, most of them associated with the placental vascular anastomoses. Fetoscopic laser coagulation (FLC) is a surgical technique that allows minimally invasive access into the uterus and has emerged as a useful tool in the management of the most common and severe of these complications, twin to twin transfusion syndrome (TTTS). Even though, preterm birth remains a common cause of adverse outcome because TTTS is associated with a 29% risk of delivering before 28 weeks.
A short cervical length (CL), defined as a CL ≤ 25 mm, detected by transvaginal ultrasound is an independent risk factor for preterm birth in twin pregnancies but no effective treatment has been described to prevent it.
Although is usually accepted that in twin pregnancies cerclage may increase the risk of preterm birth, Salomon and co-workers, found that in cases of TTTS with a CL below the 5th percentile (15 mm) at the time of surgery, performing an emergency cerclage prolonged the pregnancy and allow for better outcome, But still preterm birth after FLC remains a big challenge, so new methods to prevent it must be investigated.
Previous studies in singletons and twins have shown that the use of cervical pessary significantly reduces the frequency of birth before 32 weeks and prolongs pregnancy. The advantage of using cervical pessary is that it is less invasive than cerclage and can be removed easily. That's the reason why pessaries could be considered an alternative, non invasive option to prevent preterm birth in cases of twin to twin transfusion syndrome (TTTS) treated by laser surgery.
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 (Outcomes Assessor)
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
- •Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
- •Less than 26 weeks
- •Minimal age of 18 years
- •Informed consent signature
排除标准
- •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- •Cerclage prior to randomisation
- •Uterine malformation
- •Placenta previa
- •Active vaginal bleeding at the moment of randomization
- •Spontaneous rupture of membranes at the time of randomization
- •Death of both twins after the surgery
- •Monochorionic-monoamniotic twin pregnancy
- •Silicone allergy
- •Current participation in other RCT
研究组 & 干预措施
Usual management
Usual management of monochorionic pregnancy without the pessary placement
Arabin Cervical Pessary
The pessary will be inserted 24 hours after fetal surgery in the exploration room. This procedure does not need anaesthesia and it does not need to be done in a surgery room. During the following explorations the correct placement of the pessary is assessed, and if it does not, it can be easily adjusted.
The pessary will be removed at 37 weeks of gestation, or before if any unexpected event occurs.
干预措施: Arabin Cervical Pessary (Device)
结局指标
主要结局
Delivery before 32 weeks
时间窗: Within the first 15 days after delivery
Rate of delivery before 32 weeks
次要结局
- Rupture of membranes before 32 weeks(Within 15 days after delivery)
- Preterm birth before 34 weeks(Within 15 days after delivery)
- Preterm birth before 28 weeks(Within 15 days after delivery)
- Birth weight(Within the first 15 days after delivery)
- Preterm birth before 37 weeks(Within 15 days after delivery)
- Fetal or neonatal death(Within the first 15 days after the death)
- Neonatal morbidity(30 days after the discharge from the hospital)
- Significant maternal adverse events(Within 15 days after discharge from the hospital)
- Hospitalisation for threatened preterm labour before 32 weeks(Within 15 days after delivery)
- Preterm birth before 30 weeks(Within 15 days after delivery)
- Physical or psychological intolerance to pessary(Within 15 days after discharge from hospital)
- Time to birth(Within 15 days after delivery)
