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Management of Myelomeningocele Study (MOMS) (MOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00060606
Recruitment Status : Completed
First Posted : May 9, 2003
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Eunice 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
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Tracking Information
First Submitted Date  ICMJE May 8, 2003
First Posted Date  ICMJE May 9, 2003
Results First Submitted Date  ICMJE April 6, 2020
Results First Posted Date  ICMJE July 7, 2020
Last Update Posted Date July 7, 2020
Study Start Date  ICMJE February 2003
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • 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 the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age [ Time Frame: 30 months of age ]
    Individual outcome score is the sum of the following:
    1. Rank for the Bayley score which was constructed from the Bayley Scales of Infant Development Mental Development Index standardized score for each child at 30 months. Deaths had the lowest score of 0, lower than the lowest standardized score of 49. Scores were then ranked from 1 to 182 (1 is worst,182 is best).
    2. Rank for the difference between the anatomic and functional lesion levels of the spine was generated by a plain x-ray obtained at the 12-month visit for the anatomic level and the physical examination at 30 months for the functional level. The difference between the two was calculated where a positive difference means that the child is functioning better than expected by the level of his/her lesion. Deaths received the lowest score of -25, lower than all other possible differences. The differences were then ranked from 1 to 182 (1 is worst, 182 is best).
    For the overall score, 2 is the worst and 364 is the best.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • motor function
  • developmental progress
  • bladder development
  • renal development
  • brain development
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
Number of Participants Walking Independently at Examination [ Time Frame: 30 months of age ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Myelomeningocele Study (MOMS)
Official Title  ICMJE 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 Description

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.

One hundred eighty-three women, whose fetuses have spina bifida, were enrolled in the study and randomized to have either prenatal surgery or postnatal surgery. After a central screening process which included a medical record review, all women had an extensive baseline evaluation that included ultrasound, MRI, physical exam, social work evaluation, psychological screening, and education about spina bifida and prenatal surgery.

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

Women assigned to have prenatal surgery were scheduled for surgery within 1 to 3 days after they were randomized. They stayed near the MOMS Center until they delivered. Women in the postnatal group traveled back to their assigned MOMS Center to deliver. Both groups delivered their babies by C-section around the 37th week of their pregnancies. Babies born to women in the postnatal surgery group had their spina bifida defects closed when they were medically stable, usually within 48 hours of birth.

Children and their parents returned to their assigned MOMS Center at 1 year and 2 ½ years of age for follow-up evaluation. Motor function, developmental progress, and bladder, kidney, and brain development were assessed.

The children were asked to return for an additional follow-up visit (MOMS2) between the ages of 6-10 years. This follow-up is to determine whether children who received the surgery before birth have better health and mental outcomes and live more independently and function more safely and appropriately in daily life than those who received the surgery after birth.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Meningomyelocele
  • Spinal Dysraphism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Prenatal Surgery Group
    Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.
    Intervention: Procedure: Prenatal Myelomeningocele Repair Surgery
  • Active Comparator: Postnatal Surgery Group
    Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.
    Intervention: Procedure: Postnatal Myelomeningocele Repair Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2011)
183
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
200
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Pregnant women carrying a fetus diagnosed with myelomeningocele
  • Myelomeningocele lesion that starts no higher than T1 and no lower than S1 with hindbrain herniation present
  • Gestational age at randomization of 19 weeks 0 days to 25 weeks 6 days
  • Normal karyotype
  • Singleton pregnancy
  • United States resident
  • Able to travel to study site for study evaluation, procedures, and visits (if randomized to prenatal surgery, must stay near center until delivery)
  • Support person to travel and stay with participant

Exclusion Criteria

  • Maternal insulin-dependent pregestational diabetes
  • Short or incompetent cervix or cervical cerclage
  • Placenta previa
  • Body mass index of 35 or more
  • Previous spontaneous delivery prior to 37 weeks
  • Maternal HIV, Hepatitis-B or Hepatitis-C status positive
  • Uterine anomaly
  • Maternal medical condition which is a contraindication to surgery or general anesthesia
  • Other fetal anomaly
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060606
Other Study ID Numbers  ICMJE U01HD041665( U.S. NIH Grant/Contract )
U01HD068541 ( U.S. NIH Grant/Contract )
U01HD41666 ( Other Grant/Funding Number: NICHD )
U01HD41667 ( Other Grant/Funding Number: NICHD )
U01HD41669 ( Other Grant/Funding Number: NICHD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses.
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE
  • Eunice 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
Investigators  ICMJE
Principal Investigator: Elizabeth A Thom, PhD George Washington University, Data and Study Coordinating Center
PRS Account The George Washington University Biostatistics Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP