Prenatal Endoscopic Repair of Fetal Spina Bifida
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Successful surgery
研究概览
简要总结
The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch
详细描述
Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial.
Technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 > 18 years old, with an assumption by health insurance, understanding and speaking French
- •A term < or = 26 +0 weeks gestational age
- •Single-Pregnancy
- •Myelomeningocele with higher-level defect between S1 and T1
- •Arnold Chiari anomaly
- •No associated anomaly or chromosic anomaly
排除标准
- •severe foetal kyphoscoliosis associated
- •Increased risk of preterm birth: cervical length <15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
- •placenta previa, accreta or placental abruption
- •Maternal obesity with BMI> 35
- •Uterine anomalies : large interstitial uterine fibroid, uterine malformation
- •maternal infection with a foetal transmission risk: HIV, HBV, HCV
- •Maternal contradiction in surgery or anesthesia
- •poor social status and/or social isolation
- •impossible post-surgery follow-up
- •want to have a medical pregnancy termination
结局指标
主要结局
Successful surgery
时间窗: Before 26 gestational weeks
Composite criteria: 1. dissection of the placode 2. primary coverage or use of a patch 3. using only endoscopy with two trocars
Motor lower limb improvement outcomes
时间窗: Within the 6 months after birth
Maternal morbidity
时间窗: From surgery to delivery
Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
Neonatal surgery
时间窗: Day 0 (birth of neonates)
Need for neonatal surgery
Arnold Chiari anomaly at birth
时间窗: Day 0 (birth of neonates)
the existence of an Arnold Chiari anomaly at birth
Ventriculo-peritoneal shunt
时间窗: Within the 6 months after birth
Ventriculo-peritoneal shunt within the 6 months after birth
Level of injury
时间窗: Within the 6 months after birth
Foetal morbidity
时间窗: From surgery to delivery
Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events
次要结局
- Neurological development(Within the 12 months after birth)