Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

NCT03856034 | Recruiting DMC FDA Device

• 1 other identifier: 1249628
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Conditions

Neural Tube Defects; Spina Bifida; Myelomeningocele; Chiari Malformation

Keywords

spina bifida; myelomeningocele; neural tube defect; chiari malformation; fetoscopy; percutaneous; fetus

Outcome Measures

Primary Outcomes (1)

• Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques

  Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery

  At time of surgery until delivery, up to 21 weeks

Study Arms (1)

Fetoscopic repair

EXPERIMENTAL

Device: Fetoscopy

Interventions

Fetoscopy DEVICE

Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).

Fetoscopic repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
• Maternal age ≥18 years.
• Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
• Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
• Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
• Positive evaluation from pediatric neurology consult.
• Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.

You may not qualify if:

• Multiple gestation
• Insulin-dependent pregestational diabetes
• Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
• Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
• Presence of uterine cervical cerclage or history of incompetent cervix.
• Placenta previa or placental abruption.
• Short cervix \< 25 mm measured by cervical ultrasound.
• Obesity as defined by body mass index (BMI) of 35 or greater.
• History of previous spontaneous singleton delivery prior to 37 weeks.
• Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
• Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
• Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
• Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
• Other maternal medical condition which is a contraindication to surgery or anesthesia.
• Patient does not have a support person (e.g., husband, partner, parents).

Sponsors & Collaborators

• USFetus: lead
• Wellington Hospital: collaborator
• University of Southern California: collaborator

Study Sites (2)

University of Southern California / Huntington Memorial Hospital

Los Angeles, California, 91105, United States

RECRUITING

Wellington Regional Medical Center

Wellington, Florida, 33141, United States

RECRUITING

MeSH Terms

Conditions

Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Arnold-Chiari Malformation

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Fetal Therapies; Therapeutics; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures

Study Officials

• Ruben Quintero, MD

  Wellington Regional Medical Center

  PRINCIPAL INVESTIGATOR

• Ramen Chmait, MD

  University of Southern California/ Huntington Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Quintero, MD

CONTACT

720-753-3825; q@the-fetal-institute.com

Ramen Chmait, MD

CONTACT

626-356-3360; chmait@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 27, 2019
• Study Start: November 2, 2018
• Primary Completion: November 2, 2020
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)