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
This trial does not accept healthy volunteersQualifiers
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 population
Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Fetoscopic Neural Tube Defect Repair Devices
DeviceFetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Fetoscopic Neural Tube Defect Repair1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of minimally invasive surgical repair of NTD in fetus
Whether closure was achieved and whether the case was completed using the fetoscopic technique
Time frame
At the time of NTD repair surgerySecondary outcomes
1
Chiari II malformation reversal
Reversal of hindbrain herniation based on ultrasound, fetal MRI, and postnatal MRI
Time frame
Post-surgery ultrasound (weekly from surgery to delivery), post-surgery fetal MRI (4-6 weeks after surgery), and postnatal MRI (5-7 days after birth)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov