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Management of Myelomeningocele Study (MOMS) (MOMS)

Primary Purpose

Meningomyelocele, Spinal Dysraphism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prenatal Myelomeningocele Repair Surgery
Postnatal Myelomeningocele Repair Surgery
Sponsored by
The George Washington University Biostatistics Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningomyelocele focused on measuring Maternal fetal surgery, Fetal diagnosis, Myelomeningocele, Meningomyelocele, Open neural tube defect, ONTD, Spina bifida

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California at San Francisco
  • The Children's Hospital of Philadelphia
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prenatal Surgery Group

Postnatal Surgery Group

Arm Description

Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.

Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.

Outcomes

Primary Outcome Measures

Infant Death or Need for Ventricular Shunt by 1 Year of Life
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: Rank for the Bayley score which was constructed from the Bayley Scales of Infant Development Mental Development Index standardized score for each child at 30 months. Deaths had the lowest score of 0, lower than the lowest standardized score of 49. Scores were then ranked from 1 to 182 (1 is worst,182 is best). Rank for the difference between the anatomic and functional lesion levels of the spine was generated by a plain x-ray obtained at the 12-month visit for the anatomic level and the physical examination at 30 months for the functional level. The difference between the two was calculated where a positive difference means that the child is functioning better than expected by the level of his/her lesion. Deaths received the lowest score of -25, lower than all other possible differences. The differences were then ranked from 1 to 182 (1 is worst, 182 is best). For the overall score, 2 is the worst and 364 is the best.

Secondary Outcome Measures

Number of Participants Walking Independently at Examination

Full Information

First Posted
May 8, 2003
Last Updated
June 19, 2020
Sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia, Vanderbilt University Medical Center, University of California, San Francisco, University of Pittsburgh Medical Center, University of Houston, The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00060606
Brief Title
Management of Myelomeningocele Study (MOMS)
Acronym
MOMS
Official Title
Myelomeningocele Repair Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Washington University Biostatistics Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia, Vanderbilt University Medical Center, University of California, San Francisco, University of Pittsburgh Medical Center, University of Houston, The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningomyelocele, Spinal Dysraphism
Keywords
Maternal fetal surgery, Fetal diagnosis, Myelomeningocele, Meningomyelocele, Open neural tube defect, ONTD, Spina bifida

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prenatal Surgery Group
Arm Type
Experimental
Arm Description
Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.
Arm Title
Postnatal Surgery Group
Arm Type
Active Comparator
Arm Description
Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.
Intervention Type
Procedure
Intervention Name(s)
Prenatal Myelomeningocele Repair Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Postnatal Myelomeningocele Repair Surgery
Intervention Description
Standard postnatal surgical closure of the spina bifida defect
Primary Outcome Measure Information:
Title
Infant Death or Need for Ventricular Shunt by 1 Year of Life
Time Frame
12 months of age
Title
Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age
Description
Individual outcome score is the sum of the following: Rank for the Bayley score which was constructed from the Bayley Scales of Infant Development Mental Development Index standardized score for each child at 30 months. Deaths had the lowest score of 0, lower than the lowest standardized score of 49. Scores were then ranked from 1 to 182 (1 is worst,182 is best). Rank for the difference between the anatomic and functional lesion levels of the spine was generated by a plain x-ray obtained at the 12-month visit for the anatomic level and the physical examination at 30 months for the functional level. The difference between the two was calculated where a positive difference means that the child is functioning better than expected by the level of his/her lesion. Deaths received the lowest score of -25, lower than all other possible differences. The differences were then ranked from 1 to 182 (1 is worst, 182 is best). For the overall score, 2 is the worst and 364 is the best.
Time Frame
30 months of age
Secondary Outcome Measure Information:
Title
Number of Participants Walking Independently at Examination
Time Frame
30 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Thom, PhD
Organizational Affiliation
George Washington University, Data and Study Coordinating Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will be shared per NIH policy after the completion and publication of the main analyses.
Citations:
PubMed Identifier
21306277
Citation
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.
Results Reference
result
PubMed Identifier
26369371
Citation
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. Erratum In: J Neurosurg Pediatr. 2022 Nov 04;31(1):87-89.
Results Reference
result
PubMed Identifier
26416930
Citation
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.
Results Reference
result
PubMed Identifier
27496687
Citation
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.
Results Reference
result
PubMed Identifier
27263997
Citation
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.
Results Reference
result
PubMed Identifier
29246577
Citation
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.
Results Reference
result
PubMed Identifier
31075056
Citation
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.
Results Reference
result
PubMed Identifier
30507586
Citation
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.
Results Reference
result
PubMed Identifier
31613408
Citation
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.
Results Reference
result
PubMed Identifier
33555337
Citation
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.
Results Reference
derived
PubMed Identifier
33165214
Citation
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.
Results Reference
derived
PubMed Identifier
31980545
Citation
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.
Results Reference
derived
PubMed Identifier
30595963
Citation
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.
Results Reference
derived

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Management of Myelomeningocele Study (MOMS)

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