Management of Myelomeningocele Study (MOMS) (MOMS)

Tracking Information
First Submitted Date ICMJE	May 8, 2003
First Posted Date ICMJE	May 9, 2003
Last Update Posted Date	June 21, 2017
Study Start Date ICMJE	February 2003
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 20, 2017)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	motor function; developmental progress; bladder development; renal development; brain development
Change History	Complete list of historical versions of study NCT00060606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 20, 2017)	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 ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Management of Myelomeningocele Study (MOMS)
Official Title ICMJE	Myelomeningocele Repair Randomized Trial
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. 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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Meningomyelocele; Spinal Dysraphism
Intervention ICMJE	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.; Procedure: Postnatal Myelomeningocele Repair Surgery Standard postnatal surgical closure of the spina bifida defect
Study Arms	Experimental: 1 Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation. Intervention: Procedure: Prenatal Myelomeningocele Repair Surgery; 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. Intervention: Procedure: Postnatal Myelomeningocele Repair Surgery
Publications *	Michejda M, McCollough D. New animal model for the study of neural tube defects. Z Kinderchir. 1987 Dec;42 Suppl 1:32-5.; Heffez DS, Aryanpur J, Rotellini NA, Hutchins GM, Freeman JM. Intrauterine repair of experimental surgically created dysraphism. Neurosurgery. 1993 Jun;32(6):1005-10.; Paek BW, Farmer DL, Wilkinson CC, Albanese CT, Peacock W, Harrison MR, Jennings RW. Hindbrain herniation develops in surgically created myelomeningocele but is absent after repair in fetal lambs. Am J Obstet Gynecol. 2000 Nov;183(5):1119-23.; Tulipan N, Bruner JP, Hernanz-Schulman M, Lowe LH, Walsh WF, Nickolaus D, Oakes WJ. Effect of intrauterine myelomeningocele repair on central nervous system structure and function. Pediatr Neurosurg. 1999 Oct;31(4):183-8.; Sutton LN, Adzick NS, Bilaniuk LT, Johnson MP, Crombleholme TM, Flake AW. Improvement in hindbrain herniation demonstrated by serial fetal magnetic resonance imaging following fetal surgery for myelomeningocele. JAMA. 1999 Nov 17;282(19):1826-31.; Meuli M, Meuli-Simmen C, Hutchins GM, Seller MJ, Harrison MR, Adzick NS. The spinal cord lesion in human fetuses with myelomeningocele: implications for fetal surgery. J Pediatr Surg. 1997 Mar;32(3):448-52.; Meuli M, Meuli-Simmen C, Hutchins GM, Yingling CD, Hoffman KM, Harrison MR, Adzick NS. In utero surgery rescues neurological function at birth in sheep with spina bifida. Nat Med. 1995 Apr;1(4):342-7.; 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.; 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.; 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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 13, 2011)	183
Original Enrollment ICMJE; (submitted: June 23, 2005)	200
Actual Study Completion Date	June 2017
Actual Primary Completion Date	February 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00060606
Other Study ID Numbers ICMJE	U01HD041665( U.S. NIH Grant/Contract ); U01HD068541 ( U.S. NIH Grant/Contract ); U01HD41666 ( Other Grant/Funding Number: NICHD ); U01HD41667 ( Other Grant/Funding Number: NICHD ); U01HD41669 ( Other Grant/Funding Number: NICHD )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: Yes Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses.
Responsible Party	The George Washington University Biostatistics Center
Study Sponsor ICMJE	The George Washington University Biostatistics Center
Collaborators ICMJE	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; University of Houston; The University of Texas Health Science Center, Houston
Investigators ICMJE	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
PRS Account	The George Washington University Biostatistics Center
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP