Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele (NCT03856034) | Clinical Trial Compass
RecruitingNot Applicable
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
United States12 participantsStarted 2018-11-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
✓. Positive evaluation from pediatric neurology consult.
✓. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.
Exclusion criteria
✕. 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.
What they're measuring
1
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques
Timeframe: At time of surgery until delivery, up to 21 weeks