Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

NCT03936322•Rodrigo Ruano

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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).
+3 more 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), history of incompetent cervix with or without cerclage, and previous preterm birth.
•* Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
•* A body-mass index ≥40 at first prenatal visit.
•* 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, uterine anomalies incompatible with fetoscopy.
•* Amniotic Fluid Index (AFI) \< 6 cm if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion.
+8 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 7, 2019

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2024

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Spina BifidaMyelomeningoceleNeural Tube Defects

Interventions

Minimally invasive fetoscopic repair of MMC

DEVICE

In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy

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Myelomeningocele

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ACTIVE_NOT_RECRUITING

Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study

Inclusion Criteria

Exclusion Criteria

In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy

Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

Pediatric Powered Wheelchair Standing Devices: An Exploratory Study

Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida

Maternal-fetal Immune Responses to Fetal Surgery