Management of Myelomeningocele Study (MOMS) (MOMS)

June 19, 2020 updated by: The George Washington University Biostatistics Center

Myelomeningocele Repair Randomized Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Procedure: Postnatal Myelomeningocele Repair Surgery
Standard postnatal surgical closure of the spina bifida defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Death or Need for Ventricular Shunt by 1 Year of Life
Time Frame: 12 months of age
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
Time Frame: 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 Outcome Measures

Outcome Measure
Time Frame
Number of Participants Walking Independently at Examination
Time Frame: 30 months of age
30 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Washington University Biostatistics Center

Collaborators

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

Investigators

  • Principal Investigator: Elizabeth A Thom, PhD, George Washington University, Data and Study Coordinating Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 8, 2003

First Submitted That Met QC Criteria

May 8, 2003

First Posted (Estimate)

May 9, 2003

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The dataset will be shared per NIH policy after the completion and publication of the main analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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