Clinical Trial: Management of Myelomeningocele Study (MOMS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Myelomeningocele Repair Randomized Trial

Brief 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).

Detailed Summary:

Since 1997, more than 200 fetuses have had in utero closure of myelomeningocele by open maternal-fetal surgery. Preliminary clinical evidence suggests that this procedure reduces the incidence of shunt-dependent hydrocephalus and restores the cerebellum and brainstem to more normal configuration. However, clinical results of prenatal surgery for myelomeningocele are based on comparisons with historical controls and examine only efficacy, not safety. MOMS will determine if intrauterine repair of fetal myelomeningocele at 19 to 25 weeks of gestation improves outcomes as compared to standard postnatal repair. Outcomes assessed include death, the need for ventricular decompressive shunting by one year of life and neurologic function at 30 months of age.

Two hundred women, whose fetuses have spina bifida, will be enrolled in the study and randomized to have either prenatal surgery or postnatal surgery. After a central screening process which includes a medical record review, all women will have an extensive baseline evaluation that will include ultrasound, MRI, physical exam, social work evaluation, psychological screening, and education about spina bifida and prenatal surgery.

For women who are eligible following the central screening process, all screening, surgery and follow-up visits will be performed at one of three MOMS Centers. The mother, if eligible, and her support person will travel (at the expense of the study) to the MOMS Center for screening and randomization.

Women assigned to have prenatal surgery will be scheduled for surgery within 1 to 3 days after they are randomized. They will stay near the MOMS Center until they deliver. Women in the postnatal group will travel back to their assigned MOMS Center to deliver. Both groups will deliver their babies by C-section
Sponsor: The George Washington University Biostatistics Center

Current Primary Outcome:

  • Infant death or need for ventricular shunt by 1 year of life [ Time Frame: 12 months of age ]
  • Bayley Scales of Infant Development MDI and functional-anatomical level of lesion at 30 months of age [ Time Frame: 30 months of age ]
  • Follow-up primary outcome (MOMS2): Vineland Scales of Adaptive Behavior [ Time Frame: Age 5 to 9 ]


Original Primary Outcome:

  • motor function
  • developmental progress
  • bladder development
  • renal development
  • brain development


Current Secondary Outcome:

  • Chiari II malformation [ Time Frame: 12 months ]
  • Neurodevelopmental status [ Time Frame: 30 months of age ]
  • Ambulation status, neuromuscular defects [ Time Frame: 30 months of age ]
  • Maternal, psychological and reproductive functioning [ Time Frame: 30 months postpartum ]
  • Follow-up secondary outcome (MOMS2): Cognition [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Motor function [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Brain morphology and function [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Urologic outcomes [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Spina bifida associated outcomes [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Quality of life [ Time Frame: Age 5 to 9 ]
  • Follow-up secondary outcome (MOMS2): Maternal reproductive functioning [ Time Frame: Age 5 to 9 ]


Original Secondary Outcome:

Information By: The George Washington University Biostatistics Center

Dates:
Date Received: May 8, 2003
Date Started: February 2003
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2015