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Management of Myelomeningocele Study (MOMS) (MOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00060606
Recruitment Status : Completed
First Posted : May 9, 2003
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
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
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Meningomyelocele
Spinal Dysraphism
Interventions Procedure: Prenatal Myelomeningocele Repair Surgery
Procedure: Postnatal Myelomeningocele Repair Surgery
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prenatal Surgery Group Postnatal Surgery Group
Hide Arm/Group 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.

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.

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

Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect

Period Title: Overall Study
Started 91 92
First Primary Outcome - Shunt at 12 Mont 91 92
Completed [1] 91 91
Not Completed 0 1
[1]
Second primary outcome - 30 months
Arm/Group Title Prenatal Surgery Group Postnatal Surgery Group Total
Hide Arm/Group Description 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. Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section. Total of all reporting groups
Overall Number of Baseline Participants 91 92 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 92 participants 183 participants
29.2  (5.2) 28.7  (4.8) 28.9  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
Female
91
 100.0%
92
 100.0%
183
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
White Non-Hispanic
85
  93.4%
86
  93.5%
171
  93.4%
Black Non-Hispanic
1
   1.1%
1
   1.1%
2
   1.1%
Hispanic
3
   3.3%
4
   4.3%
7
   3.8%
Other
2
   2.2%
1
   1.1%
3
   1.6%
Gestational Age at randomization  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 91 participants 92 participants 183 participants
23.7  (1.4) 23.9  (1.3) 23.8  (1.3)
Married  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
84
  92.3%
86
  93.5%
170
  92.9%
Schooling  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 92 participants 183 participants
14.9  (1.7) 14.9  (1.7) 14.9  (1.7)
Body Mass Index at screening  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 91 participants 92 participants 183 participants
26.3  (3.7) 26.3  (3.9) 26.3  (3.8)
Severe hindbrain herniation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
27
  29.7%
23
  25.0%
50
  27.3%
Clubfoot  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
24
  26.4%
19
  20.7%
43
  23.5%
Fetal sex female  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
42
  46.2%
57
  62.0%
99
  54.1%
Nullipara   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
37
  40.7%
37
  40.2%
74
  40.4%
[1]
Measure Description: First pregnancy
Previous uterine surgeries  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
12
  13.2%
11
  12.0%
23
  12.6%
Cervical length (transvaginal)  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 91 participants 92 participants 183 participants
39.5  (7.6) 39.4  (5.9) 39.5  (6.8)
Spina bifida lesion level L3 or lower   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
62
  68.1%
76
  82.6%
138
  75.4%
[1]
Measure Description: screening ultrasound
1.Primary Outcome
Title Infant Death or Need for Ventricular Shunt by 1 Year of Life
Hide Description [Not Specified]
Time Frame 12 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal Surgery Postnatal Surgery
Hide Arm/Group 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.

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.

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

Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect

Overall Number of Participants Analyzed 91 92
Measure Type: Count of Participants
Unit of Measure: Participants
66
  72.5%
90
  97.8%
2.Primary Outcome
Title Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age
Hide Description

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.

Time Frame 30 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal Surgery Postnatal Surgery
Hide Arm/Group 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.

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.

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

Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect

Overall Number of Participants Analyzed 91 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
199.4  (80.5) 166.6  (76.7)
3.Secondary Outcome
Title Number of Participants Walking Independently at Examination
Hide Description [Not Specified]
Time Frame 30 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal Surgery Postnatal Surgery
Hide Arm/Group 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.

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.

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

Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect

Overall Number of Participants Analyzed 87 88
Measure Type: Count of Participants
Unit of Measure: Participants
39
  44.8%
21
  23.9%
Time Frame Adverse events were collected from the time of randomization through 30 months of life.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prenatal Surgery Group Postnatal Surgery Group
Hide Arm/Group 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.

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.

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

Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect

All-Cause Mortality
Prenatal Surgery Group Postnatal Surgery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)   3/92 (3.26%) 
Hide Serious Adverse Events
Prenatal Surgery Group Postnatal Surgery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)   3/92 (3.26%) 
General disorders     
Fetal or infant death *  4/91 (4.40%)  3/92 (3.26%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prenatal Surgery Group Postnatal Surgery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/92 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth A Thom
Organization: George Washington University Biostatistics Center
Phone: 301-881-9260 ext 8035
EMail: e_thom@bsc.gwu.edu
Publications of Results:
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00060606    
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 )
First Submitted: May 8, 2003
First Posted: May 9, 2003
Results First Submitted: April 6, 2020
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020