Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060606
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2003-05-08
Brief Title:
Management of Myelomeningocele Study MOMS
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
Myelomeningocele Repair Randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOMS
Brief 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
Detailed Description:
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
One hundred eighty-three women whose fetuses have spina bifida were enrolled in the study and randomized to have either prenatal surgery or postnatal surgery After a central screening process which included a medical record review all women had an extensive baseline evaluation that included ultrasound MRI physical exam social work evaluation psychological screening and education about spina bifida and prenatal surgery
For women who were eligible following the central screening process all screening surgery and follow-up visits were performed at one of three MOMS Centers The mother if eligible and her support person traveled at the expense of the study to the MOMS Center for screening and randomization
Women assigned to have prenatal surgery were scheduled for surgery within 1 to 3 days after they were randomized They stayed near the MOMS Center until they delivered Women in the postnatal group traveled back to their assigned MOMS Center to deliver Both groups delivered their babies by C-section around the 37th week of their pregnancies Babies born to women in the postnatal surgery group had their spina bifida defects closed when they were medically stable usually within 48 hours of birth
Children and their parents returned 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 were assessed
The children were 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
One hundred eighty-three women whose fetuses have spina bifida were enrolled in the study and randomized to have either prenatal surgery or postnatal surgery After a central screening process which included a medical record review all women had an extensive baseline evaluation that included ultrasound MRI physical exam social work evaluation psychological screening and education about spina bifida and prenatal surgery
For women who were eligible following the central screening process all screening surgery and follow-up visits were performed at one of three MOMS Centers The mother if eligible and her support person traveled at the expense of the study to the MOMS Center for screening and randomization
Women assigned to have prenatal surgery were scheduled for surgery within 1 to 3 days after they were randomized They stayed near the MOMS Center until they delivered Women in the postnatal group traveled back to their assigned MOMS Center to deliver Both groups delivered their babies by C-section around the 37th week of their pregnancies Babies born to women in the postnatal surgery group had their spina bifida defects closed when they were medically stable usually within 48 hours of birth
Children and their parents returned 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 were assessed
The children were 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD068541 | NIH | None | None |
| U01HD41666 | OTHER_GRANT | None | None |
| U01HD41667 | OTHER_GRANT | None | None |
| U01HD41669 | OTHER_GRANT | NICHD | httpsreporternihgovquickSearchU01HD068541 |