Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study (NCT03936322) | Clinical Trial Compass
CompletedNot Applicable
Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
United States3 participantsStarted 2019-05-07
Plain-language summary
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria
* Pregnant women - maternal age 18 years or older
* Gestational age at the time of the procedure between 19 0/7 weeks and 25 6/7 weeks
* Singleton pregnancy.
* MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral
1 (S1).
* Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation).
* Absence of chromosomal abnormalities and associated anomalies.
* 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.
* Family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
* Family meets psychosocial criteria (sufficient social support, ability to understand requirements for this study).
* Pregnant subject capable of consenting for their own participation in this study.
* Willingness to undergo an open MMC repair, if necessary
* Parental/guardian permission (informed consent) for follow up of child after birth.
Exclusion Criteria:
* Exclusion Criteria
* Fetal anomaly unrelated to MMC.
* Multiple gestation
* Declined invasive testing for karyotype (amniocentesis or CVS)
* Severe kyphosis (defined as curvature of the spina (vertebras) higher than 30o degree measured by ultrasonography or magnetic resonance imaging).
* Increased risk for preterm labor including short cervical length (\<2.0 cm),…
What they're measuring
1
Maternal Adverse Events
Timeframe: From time of surgery until delivery (up to 21 weeks)
2
Neonatal Adverse Events
Timeframe: From the time of surgery until 28 days of life (up 25 weeks)