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

NCT ID: NCT03936322

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2024-06-30

Brief 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.

Conditions

Spina Bifida; Myelomeningocele; Neural Tube Defects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pregnant women diagnosed with fetal myelomeningocele

Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.

Group Type: EXPERIMENTAL

Minimally invasive fetoscopic repair of MMC

Intervention Type: DEVICE

Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.

Interventions

Minimally invasive fetoscopic repair of MMC

Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patients HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
• Maternal medical condition that is a contraindication to surgery or anesthesia.
• A score of ≥ 29 on the Beck Depression Inventory (BDI) at screening
• Maternal hypersensitivity to collagen
• Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
• Inability to comply with the travel and follow-up requirements of the trial.
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Rodrigo Ruano

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Ruano

Regulatory Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rodrigo Ruano, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-008622

Identifier Type: -

Identifier Source: org_study_id