Prenatal Surgical Repair of Fetal Myelomeningocele
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Arnold Chiari anomaly at birth
研究概览
简要总结
The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).
The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.
详细描述
Spina bifida (SB) represents one of the most severe congenital malformation of the central nervous system and amenable to prenatal diagnosis. In the past 20 years, prenatal repair of SB has become an established technique.
The PRIUM study will include 10 cases of fetuses with prenatal diagnosis of SB and for whom the maternal willing will be to continue the pregnancy. A surgical prenatal repair of the defect will be planed at 19-25+6 weeks gestation following maternal laparotomy and hysterotomy under maternal general anesthesia. The delivery will be planed at 36 weeks'. Postnatal evaluation of the neonates will be scheduled at birth, 1 month, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •patient of majority age, with an assumption by health insurance, understanding and speaking French
- •A term between 19 and 25 +6 weeks gestational age (not for control)
- •Single-Pregnancy
- •Normal fetal karyotype
- •Myelomeningocele with higher-level defect between S1 and T1
- •Placenta not low-inserted or not covering
- •Fault-isolated ultrasound reference
排除标准
- •Age under 18 years
- •Patient foreigner who understands not French
- •Multiple Pregnancy
- •Low Placenta inserted or covering
- •Severe kyphosis
- •Placental abruption
- •Fetal malformation unrelated to the existence of myelomeningocele (the existence of a malposition of one or both feet do not represent an exclusion criterion)
- •Increased risk of preterm birth: a history of preterm delivery before 37 weeks gestational age, cervical length <26 mm before 26 weeks gestational age (not for control)
- •Bleeding active between 20 and 26 weeks gestational age (not for control)
- •Maternal obesity with BMI> 35 (not for control)
- •History of uterine surgery involving the anterior surface of the uterus (not for control)
- •Maternal contradiction in surgery or general anesthesia (not for control)
结局指标
主要结局
Arnold Chiari anomaly at birth
时间窗: Day 0
the existence of an Arnold Chiari anomaly at birth
Defect
时间窗: 3 years
the level difference between the observed level of injury and the anatomical level of the defect (as defined by the last normal upper vertebra before the defect)
次要结局
未报告次要终点