NCT03936322已完成不适用
Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Maternal Adverse Events
研究概览
简要总结
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
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
- 未提供
排除标准
- •Exclusion Criteria
- •Fetal anomaly unrelated to MMC.
- •Multiple gestation
- •Declined invasive testing for karyotype (amniocentesis or CVS)
- •Severe kyphosis (defined as curvature of the spina (vertebras) higher than 30o degree measured by ultrasonography or magnetic resonance imaging).
- •Increased risk for preterm labor including short cervical length (<2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
- •Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
- •A body-mass index ≥40 at first prenatal visit.
- •Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
- •Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy.
- •Amniotic Fluid Index (AFI) < 6 cm if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion.
- •Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
- •Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patients HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
- •Maternal medical condition that is a contraindication to surgery or anesthesia.
- •A score of ≥ 29 on the Beck Depression Inventory (BDI) at screening
- •Maternal hypersensitivity to collagen
- •Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
- •Inability to comply with the travel and follow-up requirements of the trial.
- •Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
结局指标
主要结局
Maternal Adverse Events
时间窗: From time of surgery until delivery (up to 21 weeks)
Total number of maternal adverse events
Neonatal Adverse Events
时间窗: From the time of surgery until 28 days of life (up 25 weeks)
Total number of neonatal adverse events
次要结局
未报告次要终点
研究者
Rodrigo Ruano
Regulatory Sponsor
University of Miami
研究点 (2)
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