An observational study in Neural Tube Defects and Spina Bifida, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Oregon Health and Science University · Observational
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.
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 25 is below the median of 105 across 48 observational studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Compared within Spinal Dysraphism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neural Tube Defects. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals who undergo fetoscopic Neural Tube Defect (NTD) repair. Participants will undergo fetal surgery between 24 weeks 0 days and 27 weeks 6 days.
Device: 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.
Also known as: Karl Storz Endoscopy-America, Inc., Richard Wolf Medical Instruments, Corp., Advanced Endoscopy Devices, Lexion Medical, LLC., Cook Medical, Inc., Becton Dickinson Visitec Pro, TERUMO Pinnacle, Integra LifeSciences, Applied Medical Resources
Feasibility of minimally invasive surgical repair of NTD in fetus
Whether closure was achieved and whether the case was completed using the fetoscopic technique
Time frame: At the time of NTD repair surgery
Chiari II malformation reversal
Reversal of hindbrain herniation based on ultrasound, fetal MRI, and postnatal MRI
Time frame: 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)
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