Actively Recruiting
Fetoscopic Neural Tube Defect Repair
Led by Oregon Health and Science University · Updated on 2025-04-27
25
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fetoscopic Neural Tube Defect Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 18 years or older
- Able to consent for participation
- Decision to have fetoscopic repair after counseling
- Open spina bifida with upper boundary between T1 and S1
- Gestational age between 24 0/7 and 26 6/7 weeks at surgery
- Normal karyotype or chromosomal microarray; inclusion decisions for uncertain variants by investigators
- No major cardiac anomalies by fetal echocardiogram
- Adequate social support during pregnancy
- Willingness for child follow-up evaluations after birth
You will not qualify if you...
- Multiple gestation pregnancy
- Major fetal anomalies unrelated to neural tube defect
- Fetal kyphosis of 30 degrees or more
- Previous spontaneous singleton preterm birth before 37 weeks
- Presence of cervical cerclage or history of cervical insufficiency
- Cervical length under 20 mm by ultrasound
- Placenta previa or placental abruption
- Large uterine fibroids, uterine anomalies, or fetal membrane separation increasing surgical risk
- Maternal obesity with BMI over 45 or challenging body habitus
- Alloimmunization in pregnancy including Kell sensitization or neonatal alloimmune thrombocytopenia history
- Maternal HIV or Hepatitis B positive; negative test required if status unknown
- Known Hepatitis C positive status
- Maternal medical conditions contraindicating surgery or anesthesia
- Medical co-morbidities increasing preterm delivery risk
- Inability to comply with travel and follow-up
- Psychosocial criteria not met for medical care and follow-up
- Participation in another interventional study affecting maternal or fetal outcomes
- Known allergy to collagen or chondroitin products
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Department of Ob/Gyn
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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