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CMECNE

NICHD Study Update: Does Prenatal Surgery of Myelomeningocele Improve Motor Development Beyond 2 Years Follow-Up?

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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

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

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.

Method of Participation and Request for Credit

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.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

BACKGROUND AND PURPOSE: 

  • 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 

METHODS: 

  • 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  
  • Secondary outcomes 
    • Independent ambulation and the Bayley Sales of Infant Development (2nd edition) 
  • Effects and Subgroups
    • Fetal leg movements 
    • Ventricle size 
    • Presence of hindbrain herniation 
    • Gender  
    • 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 

RESULTS: 

  • 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 

CONCLUSION: 

  • 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.  

Learn More – Primary Sources: 

The Management of Myelomeningocele Study: full cohort 30-month pediatric outcomes.

ACOG SMFM Committee Opinion 720: Maternal–Fetal Surgery for Myelomeningocele

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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.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

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Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
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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