Management of Myelomeningocele Study (MOMS) (MOMS)
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|ClinicalTrials.gov Identifier: NCT00060606|
Recruitment Status : Completed
First Posted : May 9, 2003
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Meningomyelocele Spinal Dysraphism||Procedure: Prenatal Myelomeningocele Repair Surgery Procedure: Postnatal Myelomeningocele Repair Surgery||Not Applicable|
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.
Two hundred women, whose fetuses have spina bifida, will be enrolled in the study and randomized to have either prenatal surgery or postnatal surgery. After a central screening process which includes a medical record review, all women will have an extensive baseline evaluation that will include ultrasound, MRI, physical exam, social work evaluation, psychological screening, and education about spina bifida and prenatal surgery.
For women who are eligible following the central screening process, all screening, surgery and follow-up visits will be performed at one of three MOMS Centers. The mother, if eligible, and her support person will travel (at the expense of the study) to the MOMS Center for screening and randomization.
Women assigned to have prenatal surgery will be scheduled for surgery within 1 to 3 days after they are randomized. They will stay near the MOMS Center until they deliver. Women in the postnatal group will travel back to their assigned MOMS Center to deliver. Both groups will deliver their babies by C-section around the 37th week of their pregnancies. Babies born to women in the postnatal surgery group will have their spina bifida defects closed when they are medically stable, usually within 48 hours of birth.
Children and their parents will return 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 will be assessed.
The children will be 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myelomeningocele Repair Randomized Trial|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2017|
Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.
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.
Active Comparator: 2
Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.
Procedure: Postnatal Myelomeningocele Repair Surgery
Standard postnatal surgical closure of the spina bifida defect
- 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 functional-anatomical level of lesion at 30 months of age [ Time Frame: 30 months of age ]
- Follow-up primary outcome (MOMS2): Vineland Scales of Adaptive Behavior [ Time Frame: Age 6 to 10 ]
- Chiari II malformation [ Time Frame: 12 months ]
- Neurodevelopmental status [ Time Frame: 30 months of age ]
- Ambulation status, neuromuscular defects [ Time Frame: 30 months of age ]
- Maternal, psychological and reproductive functioning [ Time Frame: 30 months postpartum ]
- Follow-up secondary outcome (MOMS2): Cognition [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Motor function [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Brain morphology and function [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Urologic outcomes [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Spina bifida associated outcomes [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Quality of life [ Time Frame: Age 6 to 10 ]
- Follow-up secondary outcome (MOMS2): Maternal reproductive functioning [ Time Frame: Age 6 to 10 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060606
|United States, California|
|University of California at San Francisco|
|San Francisco, California, United States, 94143|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Rosemary Higgins, MD||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Principal Investigator:||Elizabeth A Thom, MD||George Washington University, Data and Study Coordinating Center|