Fetoscopic repair of neural tube defects
Fetoscopic Neural Tube Defect Repair: Observational Pilot Study
This study looks at how well a special surgery done before birth can help babies with spina bifida and what happens to them after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06946563 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the outcomes of fetoscopic repair for neural tube defects, specifically spina bifida, at Oregon Health & Science University. Patients will undergo the procedure between 24 and 27 weeks of gestation, with various surgical approaches determined by individual circumstances. The study will collect data on surgical, post-operative, delivery, and neonatal outcomes, as well as follow-up evaluations throughout childhood.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 or older with a diagnosis of open spina bifida and a gestational age between 24 and 27 weeks.
Not a fit: Patients with multiple gestations or major fetal anomalies unrelated to the neural tube defect may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve maternal and neonatal outcomes for babies with neural tube defects.
How similar studies have performed: Other studies have shown promise in fetoscopic approaches for similar conditions, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Raphael Sun, MD — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.