A randomized trial of prenatal versus postnatal repair of myelomeningocele

N. Scott Adzick, Elizabeth A. Thom, Catherine Y. Spong, John W. Brock, 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

Research output: Contribution to journalArticle

848 Citations (Scopus)

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.)

Original languageEnglish (US)
Pages (from-to)993-1004
Number of pages12
JournalNew England Journal of Medicine
Volume364
Issue number11
DOIs
StatePublished - Mar 17 2011

Fingerprint

Meningomyelocele
Cerebrospinal Fluid Shunts
Confidence Intervals
Rhombencephalon
Spinal Dysraphism
Fetal Death
National Institutes of Health (U.S.)
Nervous System
Walking
Mothers
Pregnancy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Adzick, N. S., Thom, E. A., Spong, C. Y., Brock, J. W., Burrows, P. K., Johnson, M. P., ... Farmer, D. L. (2011). A randomized trial of prenatal versus postnatal repair of myelomeningocele. New England Journal of Medicine, 364(11), 993-1004. https://doi.org/10.1056/NEJMoa1014379

A randomized trial of prenatal versus postnatal repair of myelomeningocele. / Adzick, N. Scott; Thom, Elizabeth A.; Spong, Catherine Y.; Brock, John W.; Burrows, Pamela K.; Johnson, Mark P.; Howell, Lori J.; Farrell, Jody A.; Dabrowiak, Mary E.; Sutton, Leslie N.; Gupta, Nalin; Tulipan, Noel B.; D'Alton, Mary E.; Farmer, Diana L.

In: New England Journal of Medicine, Vol. 364, No. 11, 17.03.2011, p. 993-1004.

Research output: Contribution to journalArticle

Adzick, NS, Thom, EA, Spong, CY, Brock, JW, Burrows, PK, Johnson, MP, Howell, LJ, Farrell, JA, Dabrowiak, ME, Sutton, LN, Gupta, N, Tulipan, NB, D'Alton, ME & Farmer, DL 2011, 'A randomized trial of prenatal versus postnatal repair of myelomeningocele', New England Journal of Medicine, vol. 364, no. 11, pp. 993-1004. https://doi.org/10.1056/NEJMoa1014379
Adzick NS, Thom EA, Spong CY, Brock JW, Burrows PK, Johnson MP et al. A randomized trial of prenatal versus postnatal repair of myelomeningocele. New England Journal of Medicine. 2011 Mar 17;364(11):993-1004. https://doi.org/10.1056/NEJMoa1014379
Adzick, N. Scott ; Thom, Elizabeth A. ; Spong, Catherine Y. ; Brock, John W. ; Burrows, Pamela K. ; Johnson, Mark P. ; Howell, Lori J. ; Farrell, Jody A. ; Dabrowiak, Mary E. ; Sutton, Leslie N. ; Gupta, Nalin ; Tulipan, Noel B. ; D'Alton, Mary E. ; Farmer, Diana L. / A randomized trial of prenatal versus postnatal repair of myelomeningocele. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 11. pp. 993-1004.
@article{a7b4c769cf374afc86b4db92554907e2,
title = "A randomized trial of prenatal versus postnatal repair of myelomeningocele",
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.)",
author = "Adzick, {N. Scott} and Thom, {Elizabeth A.} and Spong, {Catherine Y.} and Brock, {John W.} and Burrows, {Pamela K.} and Johnson, {Mark P.} and Howell, {Lori J.} and Farrell, {Jody A.} and Dabrowiak, {Mary E.} and Sutton, {Leslie N.} and Nalin Gupta and Tulipan, {Noel B.} and D'Alton, {Mary E.} and Farmer, {Diana L}",
year = "2011",
month = "3",
day = "17",
doi = "10.1056/NEJMoa1014379",
language = "English (US)",
volume = "364",
pages = "993--1004",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "11",

}

TY - JOUR

T1 - A randomized trial of prenatal versus postnatal repair of myelomeningocele

AU - Adzick, N. Scott

AU - Thom, Elizabeth A.

AU - Spong, Catherine Y.

AU - Brock, John W.

AU - Burrows, Pamela K.

AU - Johnson, Mark P.

AU - Howell, Lori J.

AU - Farrell, Jody A.

AU - Dabrowiak, Mary E.

AU - Sutton, Leslie N.

AU - Gupta, Nalin

AU - Tulipan, Noel B.

AU - D'Alton, Mary E.

AU - Farmer, Diana L

PY - 2011/3/17

Y1 - 2011/3/17

N2 - 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.)

AB - 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.)

UR - http://www.scopus.com/inward/record.url?scp=79952810327&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952810327&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1014379

DO - 10.1056/NEJMoa1014379

M3 - Article

C2 - 21306277

AN - SCOPUS:79952810327

VL - 364

SP - 993

EP - 1004

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 11

ER -