The aim of the study is to assess a new fetal surgery approach to repair open spina bifida. The fetal group hypothesis is to perform a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair. This approach will allow investigators to make the closure of the defect and avoid the use of an hysterotomy, reducing the risk of maternal complications as uterine dehiscence (rupture), hemorrhage and preterm premature rupture of membranes (PPROM), the patient also will be able to have a vaginal delivery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. \- Pregnant women - maternal age 18 years old or older and capable of consenting for their own participation in the study
✓. \- Singleton pregnancy
✓. \- Myelomeningocele with the upper boundary located between T1 and S1
✓. \- Evidence of hindbrain herniation (confirmed on MRI) to have Arnold Chiari type II malformation)
✓. \- Absence of chromosomal abnormalities and associated anomalies.
✓. \- Gestational age at the time of the procedure will be between 19 to 26 weeks
✓. \- Normal karyotype and / or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or 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.
Exclusion criteria
✕. \- Fetal anomaly unrelated to myelomeningocele
✕. \- Sever kyphosis
✕. \- Increased risk for preterm labor included short cervical length (\<15 mm), history of incompetent cervix with or without cerclage, and previous preterm birth
✕. \- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
✕. \- A prepregnancy body mass index \> or equal to 35 Kg/m2
What they're measuring
1
Capability to achieve successful closure of the myelomeningocele by fetoscopic surgery
✕. \- Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, mayor 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