N/A
Completed N=183
Management of Myelomeningocele Study (MOMS)
Meningomyelocele · Spinal Dysraphism
Source: ClinicalTrials.gov NCT00060606 ↗
Enrolled (actual)
183
Serious AEs
3.8%
Results posted
Jul 2020
Primary outcomePrimary: Infant Death or Need for Ventricular Shunt by 1 Year of Life — 66; 90 Participants
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).
Outcome Measures
| Outcome | Result | p-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 | — |
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
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. Informational only — not medical advice.