Management of Myelomeningocele Study (MOMS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Myelomeningocele Repair Randomized Trial

Conditions
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Meningomyelocele, Spinal Dysraphism

Intervention / Treatment
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* Procedure: Prenatal Myelomeningocele Repair Surgery
* Procedure: Postnatal Myelomeningocele Repair Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prenatal Surgery Group<br>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<br>* 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.<br>|
| Active Comparator: Postnatal Surgery Group<br>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<br>* Standard postnatal surgical closure of the spina bifida defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Death or Need for Ventricular Shunt by 1 Year of Life |  | 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 | Individual outcome score is the sum of the following: 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). 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Walking Independently at Examination |  | 30 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONTD, Maternal fetal surgery, Fetal diagnosis, Myelomeningocele, Meningomyelocele, Open neural tube defect, Spina bifida