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Management of Myelomeningocele Study (MOMS)

NCT00060606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2020-07-07

Study results available
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Summary

Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal cord is not fully developed. The overlying bones and skin are incompletely formed and the underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida defects are closed soon after birth to prevent further damage to the spinal cord and nerves. The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the standard closure, surgery after birth (postnatal surgery).

Conditions

  • Meningomyelocele
  • Spinal Dysraphism

Interventions

PROCEDURE

Prenatal Myelomeningocele Repair Surgery

Fetal surgery to repair spina bifida defect performed prior to 26 weeks of gestation with delivery by C-section at approximately 37 weeks of gestation.

PROCEDURE

Postnatal Myelomeningocele Repair Surgery

Standard postnatal surgical closure of the spina bifida defect

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • University of Houston

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Elizabeth A Thom, PhD · George Washington University, Data and Study Coordinating Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2014-02-28
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00060606 on ClinicalTrials.gov