Fetoscopic Neural Tube Defect Repair

Официальное название

Fetoscopic Neural Tube Defect Repair: Observational Pilot Study

Обзор

This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.

Подробное описание

Patients undergoing fetoscopic NTD repair will be enrolled. Possible surgical approaches include completely percutaneous, laparotomy assisted, or mini laparotomy. Surgical approach will be determined by placental location, maternal body habitus, and shared decision making with the patient. The actual fetoscopic NTD repair is the same regardless of the surgical approach. Follow-up data collection will occur post-operatively, at delivery, NICU admission, and throughout childhood.

Вмешательства

• Устройство Fetoscopic Neural Tube Defect Repair Devices
  Fetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect.

Первичные конечные точки

• Feasibility of minimally invasive surgical repair of NTD in fetus [Срок оценки: At the time of NTD repair surgery]

Вторичные конечные точки (1)

• Chiari II malformation reversal [Срок оценки: Post-surgery ultrasound (weekly from surgery to delivery), post-surgery fetal MRI (4-6 weeks after surgery), and postnatal MRI (5-7 days after birth)]

Критерии участия

Критерии включения

• Maternal age 18 years or older
• Capable of consenting for their own participation in the study
• Decision to have fetoscopic repair following counseling of all options
• Open spina bifida with the upper boundary between T1 and S1
• Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
• Normal karyotype and/or normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.
• Absence of major cardiac anomalies confirmed by fetal echocardiogram
• Adequate social support throughout pregnancy
• Parental or guardian willingness to undergo follow-up evaluations of the child after birth

Критерии исключения

• Multiple gestation
• Major fetal anomalies unrelated to the neural tube defect
• Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
• Previous spontaneous singleton preterm birth prior to 37 weeks
• Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
• Cervical length less than 20 mm by endovaginal ultrasound
• Placenta previa or evidence of placental abruption
• Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits
• Maternal obesity precluding surgical access with a BMI > 45 or if the Principal Investigator determines the body habitus to be technically challenging
• Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia
• Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery
• Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened
• Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus
• Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery
• Inability of the patient to comply with travel and follow-up requirements of the study
• Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups
• Participation in another interventional study that influences maternal and fetal morbidity and mortality
• Known history of hypersensitivity to collagen products or chondroitin materials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Oregon Health & Science University — Portland

Идентификаторы

NCT: NCT06946563 · OHSU IRB 24397

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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