Fetoscopic Neural Tube Defect Repair for Spina Bifida

This study is looking at the results of a surgery called Fetoscopic Neural Tube Defect Repair for babies diagnosed with spina bifida (a birth defect where the spinal cord doesn't form completely). Doctors will perform this surgery on babies in the womb and then track the health of both the mother and baby. The main goal is to see if this minimally invasive (small incision) surgery is possible and safe. You could be eligible if you are at least 18 years old, have decided to have this surgery after discussing all options, and your baby has open spina bifida between certain spinal levels. Your baby also needs to be between 24 and almost 27 weeks of pregnancy at the time of surgery and have normal genetic test results. This study plans to enroll 25 participants, but its current recruitment status is unclear.

Study design: This is an observational study, meaning researchers will watch and record outcomes for participants who choose to have the Fetoscopic Neural Tube Defect Repair. It is a single-arm study, so all 25 participants will receive the same intervention.
What's involved: You would undergo the Fetoscopic Neural Tube Defect Repair. Researchers will collect information about your surgery, recovery, delivery, and your baby's health after birth and throughout childhood.
Compensation: Not stated in the trial record.
Follow-up: Follow-up data will be collected after surgery, at delivery, during NICU admission, and throughout childhood.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Fetoscopic Neural Tube Defect Repair

Recruiting

Not specifiedAges 18+Observational

Oregon Health and Science University

~25 participants

Updated 2025-04-27 on ClinicalTrials.gov

What's tested:Fetoscopic Neural Tube Defect Repair Devices

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Feasibility of minimally invasive surgical repair of NTD in fetus

Measured over At the time of NTD repair surgery

Conditions

Neural Tube Defects

Spina Bifida

Where it's being run

1 sites across 1 states

Oregon1

Study leadership

Raphael Sun, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Andrew Chon · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Women's Health Research Unit Department of Ob/Gyn

[email protected]

503-494-3666

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

Feasibility of minimally invasive surgical repair of NTD in fetusAt the time of NTD repair surgery
Whether closure was achieved and whether the case was completed using the fetoscopic technique

Trialytics