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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD068541 | U.S. NIH Grant/Contract | View source | |
| U01HD41666 | Other Grant/Funding Number | NICHD | |
| U01HD41667 | Other Grant/Funding Number | NICHD | |
| U01HD41669 | Other Grant/Funding Number | NICHD |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Children's Hospital of Philadelphia | OTHER |
| Vanderbilt University Medical Center | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal Surgery Group | Experimental | Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation. |
|
| Postnatal Surgery Group | Active Comparator | Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatal Myelomeningocele Repair Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Death or Need for Ventricular Shunt by 1 Year of Life | 12 months of age | |
| Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age | Individual outcome score is the sum of the following:
For the overall score, 2 is the worst and 364 is the best. | 30 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Walking Independently at Examination | 30 months of age |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Thom, PhD | George Washington University, Data and Study Coordinating Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | United States | ||
| The Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21306277 | Result | Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9. | |
| 26369371 | Result | Tulipan N, Wellons JC 3rd, Thom EA, Gupta N, Sutton LN, Burrows PK, Farmer D, Walsh W, Johnson MP, Rand L, Tolivaisa S, D'alton ME, Adzick NS; MOMS Investigators. Prenatal surgery for myelomeningocele and the need for cerebrospinal fluid shunt placement. J Neurosurg Pediatr. 2015 Dec;16(6):613-20. doi: 10.3171/2015.7.PEDS15336. Epub 2015 Sep 15. |
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The dataset will be shared per NIH policy after the completion and publication of the main analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prenatal Surgery Group | Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation. 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. |
| FG001 | Postnatal Surgery Group | Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section. Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prenatal Surgery Group | 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. |
| BG001 | Postnatal Surgery Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Death or Need for Ventricular Shunt by 1 Year of Life | Posted | Count of Participants | Participants | 12 months of age |
|
Adverse events were collected from the time of randomization through 30 months of life.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prenatal Surgery Group | Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal or infant death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth A Thom | George Washington University Biostatistics Center | 301-881-9260 | 8035 | e_thom@bsc.gwu.edu |
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| ID | Term |
|---|---|
| D008591 | Meningomyelocele |
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| University of California, San Francisco | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| University of Houston | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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| Postnatal Myelomeningocele Repair Surgery | Procedure | Standard postnatal surgical closure of the spina bifida defect |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| 26416930 | Result | Brock JW 3rd, Carr MC, Adzick NS, Burrows PK, Thomas JC, Thom EA, Howell LJ, Farrell JA, Dabrowiak ME, Farmer DL, Cheng EY, Kropp BP, Caldamone AA, Bulas DI, Tolivaisa S, Baskin LS; MOMS Investigators. Bladder Function After Fetal Surgery for Myelomeningocele. Pediatrics. 2015 Oct;136(4):e906-13. doi: 10.1542/peds.2015-2114. |
| 27496687 | Result | Johnson MP, Bennett KA, Rand L, Burrows PK, Thom EA, Howell LJ, Farrell JA, Dabrowiak ME, Brock JW 3rd, Farmer DL, Adzick NS; Management of Myelomeningocele Study Investigators. The Management of Myelomeningocele Study: obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery. Am J Obstet Gynecol. 2016 Dec;215(6):778.e1-778.e9. doi: 10.1016/j.ajog.2016.07.052. Epub 2016 Aug 2. |
| 27263997 | Result | Antiel RM, Adzick NS, Thom EA, Burrows PK, Farmer DL, Brock JW 3rd, Howell LJ, Farrell JA, Houtrow AJ; Management of Myelomeningocele Study Investigators. Impact on family and parental stress of prenatal vs postnatal repair of myelomeningocele. Am J Obstet Gynecol. 2016 Oct;215(4):522.e1-6. doi: 10.1016/j.ajog.2016.05.045. Epub 2016 Jun 2. |
| 29246577 | Result | Farmer DL, Thom EA, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Gupta N, Adzick NS; Management of Myelomeningocele Study Investigators. The Management of Myelomeningocele Study: full cohort 30-month pediatric outcomes. Am J Obstet Gynecol. 2018 Feb;218(2):256.e1-256.e13. doi: 10.1016/j.ajog.2017.12.001. Epub 2017 Dec 12. |
| 31075056 | Result | Brock JW 3rd, Thomas JC, Baskin LS, Zderic SA, Thom EA, Burrows PK, Lee H, Houtrow AJ, MacPherson C, Adzick NS; Eunice Kennedy Shriver NICHD MOMS Trial Group. Effect of Prenatal Repair of Myelomeningocele on Urological Outcomes at School Age. J Urol. 2019 Oct;202(4):812-818. doi: 10.1097/JU.0000000000000334. Epub 2019 Sep 6. |
| 30507586 | Result | Houtrow AJ, Burrows PK, Thom EA. Comparing neurodevelopmental outcomes at 30 months by presence of hydrocephalus and shunt status among children enrolled in the MOMS trial. J Pediatr Rehabil Med. 2018;11(4):227-235. doi: 10.3233/PRM-170481. |
| 31613408 | Result | Oliver ER, Heuer GG, Thom EA, Burrows PK, Didier RA, DeBari SE, Martin-Saavedra JS, Moldenhauer JS, Jatres J, Howell LJ, Adzick NS, Coleman BG. Myelomeningocele sac associated with worse lower-extremity neurological sequelae: evidence for prenatal neural stretch injury? Ultrasound Obstet Gynecol. 2020 Jun;55(6):740-746. doi: 10.1002/uog.21891. |
| 42044869 | Derived | Premkumar A, Ogu NQ, Reddy A, David H, Yamini B, DiPatri AJ Jr, Sobotka SA, Fry JT, Shaaban AF. Household income and adverse childhood outcomes after prenatal myelomeningocele repair. Am J Obstet Gynecol MFM. 2026 Apr 25;8(7):101974. doi: 10.1016/j.ajogmf.2026.101974. Online ahead of print. |
| 33555337 | Derived | Houtrow AJ, MacPherson C, Jackson-Coty J, Rivera M, Flynn L, Burrows PK, Adzick NS, Fletcher J, Gupta N, Howell LJ, Brock JW 3rd, Lee H, Walker WO, Thom EA. Prenatal Repair and Physical Functioning Among Children With Myelomeningocele: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2021 Apr 1;175(4):e205674. doi: 10.1001/jamapediatrics.2020.5674. Epub 2021 Apr 5. |
| 33165214 | Derived | Swarup I, Talwar D, Howell LJ, Adzick NS, Horn BD. Orthopaedic outcomes of prenatal versus postnatal repair of myelomeningocele. J Pediatr Orthop B. 2022 Jan 1;31(1):87-92. doi: 10.1097/BPB.0000000000000827. |
| 31980545 | Derived | Houtrow AJ, Thom EA, Fletcher JM, Burrows PK, Adzick NS, Thomas NH, Brock JW 3rd, Cooper T, Lee H, Bilaniuk L, Glenn OA, Pruthi S, MacPherson C, Farmer DL, Johnson MP, Howell LJ, Gupta N, Walker WO. Prenatal Repair of Myelomeningocele and School-age Functional Outcomes. Pediatrics. 2020 Feb;145(2):e20191544. doi: 10.1542/peds.2019-1544. |
| 30595963 | Derived | Etchegaray A, Palma F, De Rosa R, Russo RD, Beruti E, Fregonese R, Allegrotti H, Musante G, Cibert A, Storz FC, Marchionatti S. [Fetal surgery for myelomeningocele: Obstetric evolution and short-term perinatal outcomes of a cohort of 21 cases]. Surg Neurol Int. 2018 Nov 26;9(Suppl 4):S73-S84. doi: 10.4103/sni.sni_236_18. eCollection 2018. Spanish. |
Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Gestational Age at randomization | Mean | Standard Deviation | weeks |
|
| Married | Count of Participants | Participants |
|
| Schooling | Mean | Standard Deviation | years |
|
| Body Mass Index at screening | Mean | Standard Deviation | kg/m^2 |
|
| Severe hindbrain herniation | Count of Participants | Participants |
|
| Clubfoot | Count of Participants | Participants |
|
| Fetal sex female | Count of Participants | Participants |
|
| Nullipara | First pregnancy | Count of Participants | Participants |
|
| Previous uterine surgeries | Count of Participants | Participants |
|
| Cervical length (transvaginal) | Mean | Standard Deviation | mm |
|
| Spina bifida lesion level L3 or lower | screening ultrasound | Count of Participants | Participants |
|
|
|
| Primary | Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age | Individual outcome score is the sum of the following:
For the overall score, 2 is the worst and 364 is the best. | Posted | Mean | Standard Deviation | units on a scale | 30 months of age |
|
|
|
| Secondary | Number of Participants Walking Independently at Examination | Posted | Count of Participants | Participants | 30 months of age |
|
|
|
| 4 |
| 91 |
| 4 |
| 91 |
| 0 |
| 91 |
| EG001 | Postnatal Surgery Group | Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section. Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect | 3 | 92 | 3 | 92 | 0 | 92 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |