Fetoscopic Meningomyelocele Repair Study (NCT02230072) | Clinical Trial Compass
CompletedPhase 1
Fetoscopic Meningomyelocele Repair Study
United States60 participantsStarted 2014-07-29
Plain-language summary
The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.
The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered 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),
✓. 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 CVS). If there is a balanced translocation with normal MCA with no other anomalies the candidate can be included. Patients declining invasive testing will be excluded.
✓. Family has considered and declined the option of termination of the pregnancy at less than 24 weeks,
✕. 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, and uterine anomalies,
✕. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy,