Fetoscopic Neural Tube Defect Repair

Recruiting now

Conditions studied: Neural Tube Defects, Spina Bifida

In brief

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.

Key facts

Study ID

NCT06946563

Run by

Oregon Health and Science University

People needed

25

Starts

2023-04-01

Expected to finish

2033-04-01

Last updated by the study team

2025-04-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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