Status:
RECRUITING
Fetoscopic Neural Tube Defect Repair
Lead Sponsor:
Oregon Health and Science University
Conditions:
Neural Tube Defects
Spina Bifida
Eligibility:
FEMALE
18+ years
Brief Summary
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). Fe...
Detailed Description
Patients undergoing fetoscopic NTD repair will be enrolled. Possible surgical approaches include completely percutaneous, laparotomy assisted, or mini laparotomy. Surgical approach will be determined ...
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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2033
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06946563
Start Date
April 1 2023
End Date
April 1 2033
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health & Science University
Portland, Oregon, United States, 97239