NICHD Study Update: Does Prenatal Surgery of Myelomeningocele Improve Motor Development Beyond 2 Years Follow-Up?
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe the study design of the NICHD study on prenatal myelomeningocele repair 2. Discuss findings at 30 month follow up on children who underwent myelomeningocele repair
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
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Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from March 12 2018 through March 11 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.
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The initial report of the NICHD prenatal myelomeningocele study demonstrated improvement in the following
Decreased hindbrain herniation and consequent need for shunting and improved distal neurologic function
Long-term outcomes have confirmed shunting benefit but data on neurologic and motor function outcomes were lacking
Farmer et al. (Am J Obstet Gynecol., 2018) report the 30-month outcomes for the entire cohort of patients randomized to either prenatal or postnatal repair of myelomeningocele
Follow-up analyses of NICHD sponsored Management of Myelomeningocele Study
Women had been randomly assigned to undergo
Standard postnatal repair
Prenatal repair at <26 weeks gestation
Primary outcome of the study was a composite of mental development and motor function outcome at 30 days
Independent ambulation and the Bayley Sales of Infant Development (2nd edition)
Effects and Subgroups
Fetal leg movements
Presence of hindbrain herniation
Location of the myelomeningocele lesion
Within the prenatal surgery group only, these and other baseline parameters were evaluated as predictors of 30-month motor and cognitive outcomes
Researchers also assessed if the presence or absence of a shunt at 1 year was associated with 30-month motor outcomes
Data from 183 subjects were analyzed
Prenatal repair improved the primary outcome
Composite score of mental development and motor function was 199.4 ± 80.5 vs 166.7 ± 76.7 (P=.004)
Prenatal surgery resulted in improvements in the secondary outcomes of
Independent ambulation (44.8% vs 23.9%, P=.004)
Self-care score (20.8 vs 19.0, P=.006)
Mean Bayley Scales of Infant Development, psychomotor development index (17.3% vs 15.1%, P=.03)
Prenatal surgery did not affect cognitive development at 30 months
Boys demonstrated slightly better improvement in functional level and psychomotor development index
Independent ambulation was associated with
Patients receiving prenatal surgery
The presence of in utero ankle, knee, and hip movement
Absence of a sac over the lesion and a myelomeningocele lesion ≤L3
Postnatal motor function showed no correlation with either prenatal ventricular size or postnatal shunt placement
The full cohort data of 30-month cognitive development and motor function supported previous findings
Prenatal surgery of myelomeningocele improved motor function, mental development, independent ambulation, self care score
Indicators of independent ambulation were identified including presence of in utero joint movement and absence of sac over the lesion and a lesion ≤L3.
Future research should focus on longer-term follow up to school age
This study did not use fetoscopic methods, which also awaits further research
Primary benefit of fetoscopy would be to avoid requirement for cesarean section
The ACOG / SMFM Committee Opinion states
Open maternal–fetal surgery for myelomeningocele repair has been demonstrated to improve a number of important pediatric outcomes at the expense of procedure-associated maternal and fetal risks.
Women with pregnancies complicated by fetal myelomeningocele who meet established criteria for in utero repair should be counseled in nondirective fashion regarding all management options, including the possibility of open maternal–fetal surgery.
Interested candidates for fetal myelomeningocele repair should be referred for further assessment and consultation to a fetal therapy center that offers this intervention and possesses the expertise, multi-disciplinary team, services, and facilities to provide detailed information regarding maternal–fetal surgery and the intensive care required for patients who choose to undergo open maternal–fetal surgery.
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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