Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Mar 17;364(11):993-1004.
doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

A randomized trial of prenatal versus postnatal repair of myelomeningocele

N Scott Adzick  1 , Elizabeth A Thom, Catherine Y Spong, John W Brock 3rd, Pamela K Burrows, Mark P Johnson, Lori J Howell, Jody A Farrell, Mary E Dabrowiak, Leslie N Sutton, Nalin Gupta, Noel B Tulipan, Mary E D'Alton, Diana L Farmer; MOMS Investigators
Collaborators, Affiliations
Randomized Controlled Trial

A randomized trial of prenatal versus postnatal repair of myelomeningocele

N Scott Adzick et al. N Engl J Med. .

Abstract

Background: Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair.

Methods: We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function.

Results: The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery.

Conclusions: Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Prenatal Repair of Myelomeningocele.
Figure 2
Figure 2
Enrollment and Outcomes.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Boulet SL, Yang Q, Mai C, et al. Trends in the postfortification prevalence of spina bifida and anencephaly in the United States. Birth Defects Res A Clin Mol Teratol. 2008;82:527–32. - PubMed
    1. Shurtleff DB, Luthy DA, Nyberg DA, et al. Meningomyelocele: management in utero and post natum. Ciba Found Symp. 1994;181:270–86. - PubMed
    1. Hunt GM. The median survival time in open spina bifida. Dev Med Child Neurol. 1997;39:568. - PubMed
    1. Manning SM, Jennings R, Madsen JR. Pathophysiology, prevention and potential treatment of neural tube defects. Ment Retard Dev Disabil Res Rev. 2000;6:6–14. - PubMed
    1. Mitchell LE, Adzick NS, Melchionne J, et al. Spina bifida. Lancet. 2004;364:1885–95. - PubMed

Publication types

MeSH terms

Associated data