Management of Myelomeningocele Study (MOMS)

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · May 8, 2003

Keywords

ClinConnect 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 p...

Gender

FEMALE

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