Management of Myelomeningocele Study (MOMS) - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00060606

Purpose

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).

Condition	Intervention
Meningomyelocele Spinal Dysraphism	Procedure: Prenatal Myelomeningocele Repair Surgery Procedure: Postnatal Myelomeningocele Repair Surgery

MedlinePlus related topics: Prenatal Care Spina Bifida

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:

Myelomeningocele Repair Randomized Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Infant death or need for ventricular shunt by 1 year of life [ Time Frame: 12 months of age ] [ Designated as safety issue: No ]
Bayley Scales of Infant Development MDI and functional-anatomical level of lesion at 30 months of age [ Time Frame: 30 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chiari II malformation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Neurodevelopmental status [ Time Frame: 30 months of age ] [ Designated as safety issue: No ]
Ambulation status, neuromuscular defects [ Time Frame: 30 months of age ] [ Designated as safety issue: No ]
Maternal, psychological and reproductive functioning [ Time Frame: 30 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:

200

Study Start Date:

February 2003

Estimated Study Completion Date:

December 2011

Estimated Primary Completion Date:

December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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 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.
2: 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 Standard postnatal surgical closure of the spina bifida defect

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.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060606

Contacts

Contact: Program Coordinator	866-275-6667	MOMS@biostat.bsc.gwu.edu
Contact: Catherine Spong, MD	301-496-5575	spongc@exchange.nih.gov

Locations

United States, California
University of California at San Francisco	Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Diana L. Farmer, MD
United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Scott Adzick, MD
United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Edmund Yang, MD

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Director:	Catherine Spong, 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