Management of Myelomeningocele Study (MOMS)

Completed · Not applicable

Conditions studied: Meningomyelocele, Spinal Dysraphism

In brief

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).

Key facts

Study ID

NCT00060606

Run by

The George Washington University Biostatistics Center

People needed

183

Starts

2003-02-01

Expected to finish

2017-06-01

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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