Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUSFetus
About this trial
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
Maternal age ≥18 years.
Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
Disqualifiers
Multiple gestation
Insulin-dependent pregestational diabetes
Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
Trial design
Design model
Single group
Treatments tested in this trial
Fetoscopy
DevicePatients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Fetoscopic repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques
Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery
Time frame
At time of surgery until delivery, up to 21 weeksSponsors and contacts
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Source ClinicalTrials.gov