Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study (NCT03794011) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
United States38 participantsStarted 2018-12-18
Plain-language summary
The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique.
The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.
Who can participate
Age range18 Years – 64 Years
SexFEMALE
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Inclusion criteria
✓. Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study.
✓. Singleton pregnancy.
✓. MMC with the upper boundary located between T1 and S1.
✓. Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation). An exception will be made for patients unable to have an MRI due to implants or any medical reasons. These patients will have the Arnold-Chiari type II malformation reviewed by ultrasonography.
✓. Absence of chromosomal abnormalities and associated anomalies
✓. Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks.
✓. Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded. Results by flouorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
✓. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
Exclusion criteria
✕. Fetal anomaly unrelated to MMC.
✕. Severe kyphosis.
✕. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
✕. Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
✕. A pre-pregnancy body-mass index ≥40.
✕. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
✕. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, or uterine anomalies.
✕. Maternal-fetal Rh alloimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.