Management of Myelomeningocele Study (MOMS)

NCT00060606 | Completed Results DMC

• 5 other identifiers: U01HD041665U01HD068541U01HD41666U01HD41667U01HD41669
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 3

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).

Conditions

Meningomyelocele; Spinal Dysraphism

Keywords

Maternal fetal surgery; Fetal diagnosis; Myelomeningocele; Meningomyelocele; Open neural tube defect; ONTD; Spina bifida

Outcome Measures

Primary Outcomes (2)

• 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: 1. 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). 2. 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.

  30 months of age

Secondary Outcomes (1)

• Number of Participants Walking Independently at Examination

  30 months of age

Study Arms (2)

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.

Procedure: Prenatal Myelomeningocele Repair Surgery

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.

Procedure: Postnatal Myelomeningocele Repair Surgery

Interventions

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.

Prenatal Surgery Group

Postnatal Myelomeningocele Repair Surgery PROCEDURE

Standard postnatal surgical closure of the spina bifida defect

Postnatal Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Children's Hospital of Philadelphia: collaborator
• Vanderbilt University Medical Center: collaborator
• University of California, San Francisco: collaborator
• University of Pittsburgh Medical Center: collaborator
• University of Houston: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (3)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (13)

• 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.

  PMID: 21306277 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.

  PMID: 26369371 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.

  PMID: 26416930 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.

  PMID: 27496687 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.

  PMID: 27263997 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.

  PMID: 29246577 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.

  PMID: 31075056 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.

  PMID: 30507586 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.

  PMID: 31613408 RESULT

• 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.

  PMID: 33555337 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.

  PMID: 33165214 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.

  PMID: 31980545 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.

  PMID: 30595963 DERIVED

MeSH Terms

Conditions

Meningomyelocele; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Elizabeth A Thom
• Organization: George Washington University Biostatistics Center

e_thom@bsc.gwu.edu

301-881-9260

Study Officials

• Elizabeth A Thom, PhD

  George Washington University, Data and Study Coordinating Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2003
• First Posted: May 9, 2003
• Study Start: February 1, 2003
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2017
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)