A randomized trial of prenatal versus postnatal repair of myelomeningocele
N Scott Adzick, 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, Michael Harrison, Joseph Bruner, Dorothy Bulas, Charles Fitz, Gilbert Vezina, D Douglas Cochrane, James Drake, John Kestle, Jerry Oakes, Alex Espinosa, Julia Hayes, Elizabeth Higley, Rita Jeremy, Rowena Korobkin, David Kube, Leanne Pollard, Jonathan Rowland, Elizabeth Saslow, Toni Whitaker, Mario Petersen, Melissa Fallone, Theresa Leach, Susan Anderson, George Macones, Michael Ross, Donald Stablein, Alessandro Ghidini, Michele Prince, Barbara Schmidt, Antoine Khoury, Sonya Oppenheimer, John McLaughlin, Reverend Phillip Cato, Kellie Murphy, Dale Phelps, Keith Aronyk, William Hay Jr, Mary E Hannah, Jeremy Sugarman, Alan Flake, Holly Hedrick, Jamie Koh, Jack Rychik, David Cohen, Natalie Rintoul, Beverly Coleman, Patrick Pasquariello, Enrico Danzer, Larissa Bilaniuk, Martha Hudson, Michael Carr, Michael Bebbington, Julie Moldenhauer, R Douglas Wilson, Michael Harrison, Hanmin Lee, Larry Rand, Tamara Ryan, Cindy Lazzaretti, Rachel Perry, Stephanie Berman, Vicki Feldstein, Ruth Goldstein, Peter Callen, Orit Glenn, Larry Baskin, Mark Rosen, Charles Cauldwell, Vilma Zarate, Katharine Wenstrom, Lisa Trusler, Joseph Bruner, Bill Walsh, Edmund Yang, Ann Kavanaugh-McHugh, Tracy Perry, Jennifer Anderson, Mark Bliton, Denise Pepin, Jessica Ratay, Erin Greenbaum Musok, Kristen Holloway, Catherine Shaer, Shanika Gregory, Julia Zachary, Lucy Leuchtenburg, Jeremy Drehmer, Megan Mitchell, Susan Tolivaisa, Nancy Chescheir, Marian Willinger, N Scott Adzick, 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, Michael Harrison, Joseph Bruner, Dorothy Bulas, Charles Fitz, Gilbert Vezina, D Douglas Cochrane, James Drake, John Kestle, Jerry Oakes, Alex Espinosa, Julia Hayes, Elizabeth Higley, Rita Jeremy, Rowena Korobkin, David Kube, Leanne Pollard, Jonathan Rowland, Elizabeth Saslow, Toni Whitaker, Mario Petersen, Melissa Fallone, Theresa Leach, Susan Anderson, George Macones, Michael Ross, Donald Stablein, Alessandro Ghidini, Michele Prince, Barbara Schmidt, Antoine Khoury, Sonya Oppenheimer, John McLaughlin, Reverend Phillip Cato, Kellie Murphy, Dale Phelps, Keith Aronyk, William Hay Jr, Mary E Hannah, Jeremy Sugarman, Alan Flake, Holly Hedrick, Jamie Koh, Jack Rychik, David Cohen, Natalie Rintoul, Beverly Coleman, Patrick Pasquariello, Enrico Danzer, Larissa Bilaniuk, Martha Hudson, Michael Carr, Michael Bebbington, Julie Moldenhauer, R Douglas Wilson, Michael Harrison, Hanmin Lee, Larry Rand, Tamara Ryan, Cindy Lazzaretti, Rachel Perry, Stephanie Berman, Vicki Feldstein, Ruth Goldstein, Peter Callen, Orit Glenn, Larry Baskin, Mark Rosen, Charles Cauldwell, Vilma Zarate, Katharine Wenstrom, Lisa Trusler, Joseph Bruner, Bill Walsh, Edmund Yang, Ann Kavanaugh-McHugh, Tracy Perry, Jennifer Anderson, Mark Bliton, Denise Pepin, Jessica Ratay, Erin Greenbaum Musok, Kristen Holloway, Catherine Shaer, Shanika Gregory, Julia Zachary, Lucy Leuchtenburg, Jeremy Drehmer, Megan Mitchell, Susan Tolivaisa, Nancy Chescheir, Marian Willinger
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.).
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Source: PubMed