Trial Outcomes & Findings for Management of Myelomeningocele Study (MOMS) (NCT NCT00060606)
NCT ID: NCT00060606
Last Updated: 2020-07-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
12 months of age
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
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.
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 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.
Postnatal Myelomeningocele Repair Surgery: Standard postnatal surgical closure of the spina bifida defect
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
92
|
|
Overall Study
First Primary Outcome - Shunt at 12 Mont
|
91
|
92
|
|
Overall Study
COMPLETED
|
91
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Myelomeningocele Study (MOMS)
Baseline characteristics by cohort
| Measure |
Prenatal Surgery Group
n=91 Participants
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 Surgery Group
n=92 Participants
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
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
28.9 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gestational Age at randomization
|
23.7 weeks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
23.9 weeks
STANDARD_DEVIATION 1.3 • n=7 Participants
|
23.8 weeks
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Married
|
84 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Schooling
|
14.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Body Mass Index at screening
|
26.3 kg/m^2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Severe hindbrain herniation
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Clubfoot
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Fetal sex female
|
42 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Nullipara
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Previous uterine surgeries
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Cervical length (transvaginal)
|
39.5 mm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
39.4 mm
STANDARD_DEVIATION 5.9 • n=7 Participants
|
39.5 mm
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Spina bifida lesion level L3 or lower
|
62 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months of ageOutcome measures
| Measure |
Prenatal Surgery
n=91 Participants
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.
|
Postnatal Surgery
n=92 Participants
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
|
|---|---|---|
|
Infant Death or Need for Ventricular Shunt by 1 Year of Life
|
66 Participants
|
90 Participants
|
PRIMARY outcome
Timeframe: 30 months of ageIndividual 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.
Outcome measures
| Measure |
Prenatal Surgery
n=91 Participants
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.
|
Postnatal Surgery
n=91 Participants
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
|
|---|---|---|
|
Bayley Scales of Infant Development MDI and the Difference Between the Functional and Anatomical Level of Lesion at 30 Months of Age
|
199.4 units on a scale
Standard Deviation 80.5
|
166.6 units on a scale
Standard Deviation 76.7
|
SECONDARY outcome
Timeframe: 30 months of ageOutcome measures
| Measure |
Prenatal Surgery
n=87 Participants
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.
|
Postnatal Surgery
n=88 Participants
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
|
|---|---|---|
|
Number of Participants Walking Independently at Examination
|
39 Participants
|
21 Participants
|
Adverse Events
Prenatal Surgery Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 4 deaths
Postnatal Surgery Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Prenatal Surgery Group
n=91 participants at risk
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.
|
Postnatal Surgery Group
n=92 participants at risk
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
|
|---|---|---|
|
General disorders
Fetal or infant death
|
4.4%
4/91 • Adverse events were collected from the time of randomization through 30 months of life.
|
3.3%
3/92 • Adverse events were collected from the time of randomization through 30 months of life.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elizabeth A Thom
George Washington University Biostatistics Center
Phone: 301-881-9260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60