At a glance

ClinicalIndex Comparison Record

N/ACompleted· 183 enrolled

Drug / intervention

Prenatal Myelomeningocele Repair Surgery +1 moreprocedure

Likely dose

Prenatal fetal surgery to repair myelomeningocele defect prior to 26 weeks of gestation, or postnatal surgical closureAI-extracted

Key inclusion· 7

✓Pregnant women carrying a fetus diagnosed with myelomeningocele
✓Myelomeningocele lesion location between T1 (top) and S1 (bottom) with hindbrain herniation
✓Gestational age between 19 weeks 0 days and 25 weeks 6 days at randomization
✓Normal karyotype (chromosomal test)

Key exclusion· 9

✕Maternal insulin-dependent pregestational diabetes
✕Short or incompetent cervix or cervical cerclage in place
✕Placenta previa
✕Maternal BMI of 35 or higher

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00060606

NCT00060606N/ACompleted

Compare CT.gov

Myelomeningocele Repair Randomized Trial

The George Washington University Biostatistics Center·interventional·Posted May 9, 2003·Updated Jul 7, 2020

In Brief

A clinical study evaluating Prenatal Myelomeningocele Repair Surgery and Postnatal Myelomeningocele Repair Surgery for Meningomyelocele and Spinal Dysraphism. Completed, enrolled 183 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMeningomyelocele, Spinal Dysraphism

CountriesUnited States

CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia, Vanderbilt University Medical Center, University of California, San Francisco, University of Pittsburgh Medical Center, University of Houston, The University of Texas Health Science Center, Houston

Timeline

N/ACompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2003

First PostedMay 2003

Primary CompletionFeb 2014

Study CompletionJun 2017

TodayJul 2026

First PostedMay 9, 2003

Enrollment StartFeb 1, 2003

Primary CompletionFeb 1, 2014

Study CompletionJun 1, 2017

TodayJul 2, 2026

Enrollment to primary: 11 yearsPosted 23.1 years ago

Interventions

Prenatal Myelomeningocele Repair Surgeryprocedure

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.

Postnatal Myelomeningocele Repair Surgeryprocedure

Standard postnatal surgical closure of the spina bifida defect