Fetoscopic Neural Tube Defect Repair
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fetoscopic Neural Tube Defect Repair Devices
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov