Actively Recruiting
Fetoscopic Neural Tube Defect Repair: Observational Pilot Study
Led by Oregon Health and Science University · Updated on 2025-04-27
25
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect detailed information on mothers and newborns who undergo fetoscopic repair for Neural Tube Defects (NTD), including spina bifida. The study is observational and takes place at Oregon Health & Science University, focusing on surgical, post-operative, delivery, and neonatal outcomes. Fetoscopic repair is performed between 24 weeks 0 days and 27 weeks 6 days of pregnancy. Participants will have fetoscopic NTD repair through one of several surgical approaches, such as completely percutaneous, laparotomy assisted, or mini laparotomy, depending on factors like placental location and maternal body type. The repair procedure involves accessing the uterus, administering fetal anesthesia, and closing the neural tube defect. Follow-up data will be collected after surgery, at delivery, during neonatal intensive care unit admission, and through childhood. Throughout the study, participants will be monitored at various points including post-surgery ultrasounds, fetal MRIs, and postnatal MRIs to track outcomes like the reversal of Chiari II malformation. The main measure is the feasibility of minimally invasive fetal surgery. Researchers will observe surgical success, health outcomes for mother and baby, and long-term effects during childhood. Participation includes multiple assessments and follow-ups over time.
CONDITIONS
Brief 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 own 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 by invasive testing
- No major cardiac anomalies by fetal echocardiogram
- Adequate social support during pregnancy
- Willingness for follow-up evaluations of child 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 less than 20 mm by endovaginal ultrasound
- Placenta previa or placental abruption
- Large uterine fibroids, uterine anomalies, or fetal membrane separation posing surgical risk
- Maternal obesity with BMI over 45 or technically challenging body habitus
- Alloimmunization in pregnancy including Kell sensitization or neonatal alloimmune thrombocytopenia history
- Maternal HIV or Hepatitis B positive status or unknown status without confirmed negative test
- Known Hepatitis C positivity
- Maternal medical conditions contraindicating surgery or anesthesia
- Medical co-morbidities increasing risk of preterm delivery
- Inability to comply with travel and follow-up requirements
- Psychosocial criteria not met for medical care and follow-up
- Participation in another interventional study affecting maternal or fetal outcomes
- Known allergy to collagen products or chondroitin materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery performed between 24 weeks 0 days and 27 weeks 6 days of gestation
Participants undergo fetoscopic Neural Tube Defect repair surgery using minimally invasive techniques. The surgical approach varies depending on individual factors such as placental location and maternal body habitus.
1 surgical procedure (in-person)
Duration - From surgery until delivery (weekly ultrasound) and up to 6 weeks post-surgery (fetal MRI)
Participants are followed after surgery with ultrasound and MRI assessments to monitor surgical outcomes and fetal development.
Weekly ultrasound visits from surgery to delivery and 1 fetal MRI visit 4 to 6 weeks after surgery
Duration - From delivery through childhood
Participants and their infants are followed at delivery, neonatal intensive care unit (NICU) admission, and throughout childhood to monitor health and development.
Visits at delivery, NICU admission, and periodic follow-ups during childhood
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
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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