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N/A N=183 Randomized Treatment

Management of Myelomeningocele Study (MOMS)

Meningomyelocele · Spinal Dysraphism

Bottom Line

View on ClinicalTrials.gov: NCT00060606 ↗
Enrolled (actual)
183
Serious AEs
3.8%
Results posted
Jul 2020
Primary outcome: Primary: Infant Death or Need for Ventricular Shunt by 1 Year of Life — 66; 90 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prenatal Myelomeningocele Repair Surgery (Procedure); Postnatal Myelomeningocele Repair Surgery (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
The George Washington University Biostatistics Center
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Infant Death or Need for Ventricular Shunt by 1 Year of Life		 66; 90 —
PRIMARY
Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age		 199.4; 166.6 —
SECONDARY
Number of Participants Walking Independently at Examination		 39; 21 —

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).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00060606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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