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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neural Tube Defects; Myelomeningocele; Spina Bifida
• Intervention / Treatment: Device: Minimally invasive fetoscopic repair of MMC

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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), 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal adverse events	Total number of maternal adverse events	5 years
Neonatal adverse events	Total number of neonatal adverse events	5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Meningomyelocele; Spina Bifida Cystica; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: 18-008622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes