The Management of Myelomeningocele Study: obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery

Mark P. Johnson, Kelly A. Bennett, Larry Rand, Pamela K. Burrows, Elizabeth A. Thom, Lori J. Howell, Jody A. Farrell, Mary E. Dabrowiak, John W. Brock, Diana L Farmer, N. Scott Adzick

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Background The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal closure of myelomeningocele. The trial was stopped early at recommendation of the data and safety monitoring committee and outcome data for 158 of the 183 randomized women published. Objective In this report, pregnancy outcomes for the complete trial cohort are presented. We also sought to analyze risk factors for adverse pregnancy outcome among those women who underwent prenatal myelomeningocele repair. Study Design Pregnancy outcomes were compared between the 2 surgery groups. For women who underwent prenatal surgery, antecedent demographic, surgical, and pregnancy complication risk factors were evaluated for the following outcomes: premature spontaneous membrane rupture ≤34 weeks 0 days (preterm premature rupture of membranes), spontaneous membrane rupture at any gestational age, preterm delivery at ≤34 weeks 0 days, nonintact hysterotomy (minimal uterine wall tissue between fetal membranes and uterine serosa, or partial or complete dehiscence at delivery), and chorioamniotic membrane separation. Risk factors were evaluated using χ2 and Wilcoxon tests and multivariable logistic regression. Results A total of 183 women were randomized: 91 to prenatal and 92 to postnatal surgery groups. Analysis of the complete cohort confirmed initial findings: that prenatal surgery was associated with an increased risk for membrane separation, oligohydramnios, spontaneous membrane rupture, spontaneous onset of labor, and earlier gestational age at birth. In multivariable logistic regression of the prenatal surgery group adjusting for clinical center, earlier gestational age at surgery and chorioamniotic membrane separation were associated with increased risk of spontaneous membrane rupture (odds ratio, 1.49; 95% confidence interval, 1.01–2.22; and odds ratio, 2.96, 95% confidence interval, 1.05–8.35, respectively). Oligohydramnios was associated with an increased risk of subsequent preterm delivery (odds ratio, 9.21; 95% confidence interval, 2.19–38.78). Nulliparity was a risk factor for nonintact hysterotomy (odds ratio, 3.68; 95% confidence interval, 1.35–10.05). Conclusion Despite the confirmed benefits of prenatal surgery, considerable maternal and fetal risk exists compared with postnatal repair. Early gestational age at surgery and development of chorioamniotic membrane separation are risk factors for ruptured membranes. Oligohydramnios is a risk factor for preterm delivery and nulliparity is a risk factor for nonintact hysterotomy at delivery.

Original languageEnglish (US)
Pages (from-to)778.e1-778.e9
JournalAmerican Journal of Obstetrics and Gynecology
Volume215
Issue number6
DOIs
StatePublished - Dec 1 2016
Externally publishedYes

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Meningomyelocele
Outcome Assessment (Health Care)
Membranes
Spontaneous Rupture
Hysterotomy
Oligohydramnios
Gestational Age
Pregnancy Outcome
Odds Ratio
Confidence Intervals
Parity
Clinical Trials Data Monitoring Committees
Logistic Models
Labor Onset
Extraembryonic Membranes
Serous Membrane
Pregnancy Complications
Multicenter Studies
Cohort Studies
Mothers

Keywords

  • fetal myelomeningocele
  • fetal spina bifida
  • fetal therapy
  • prenatal surgery

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

The Management of Myelomeningocele Study : obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery. / Johnson, Mark P.; Bennett, Kelly A.; Rand, Larry; Burrows, Pamela K.; Thom, Elizabeth A.; Howell, Lori J.; Farrell, Jody A.; Dabrowiak, Mary E.; Brock, John W.; Farmer, Diana L; Adzick, N. Scott.

In: American Journal of Obstetrics and Gynecology, Vol. 215, No. 6, 01.12.2016, p. 778.e1-778.e9.

Research output: Contribution to journalArticle

Johnson, MP, Bennett, KA, Rand, L, Burrows, PK, Thom, EA, Howell, LJ, Farrell, JA, Dabrowiak, ME, Brock, JW, Farmer, DL & Adzick, NS 2016, 'The Management of Myelomeningocele Study: obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery', American Journal of Obstetrics and Gynecology, vol. 215, no. 6, pp. 778.e1-778.e9. https://doi.org/10.1016/j.ajog.2016.07.052
Johnson, Mark P. ; Bennett, Kelly A. ; Rand, Larry ; Burrows, Pamela K. ; Thom, Elizabeth A. ; Howell, Lori J. ; Farrell, Jody A. ; Dabrowiak, Mary E. ; Brock, John W. ; Farmer, Diana L ; Adzick, N. Scott. / The Management of Myelomeningocele Study : obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery. In: American Journal of Obstetrics and Gynecology. 2016 ; Vol. 215, No. 6. pp. 778.e1-778.e9.
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abstract = "Background The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal closure of myelomeningocele. The trial was stopped early at recommendation of the data and safety monitoring committee and outcome data for 158 of the 183 randomized women published. Objective In this report, pregnancy outcomes for the complete trial cohort are presented. We also sought to analyze risk factors for adverse pregnancy outcome among those women who underwent prenatal myelomeningocele repair. Study Design Pregnancy outcomes were compared between the 2 surgery groups. For women who underwent prenatal surgery, antecedent demographic, surgical, and pregnancy complication risk factors were evaluated for the following outcomes: premature spontaneous membrane rupture ≤34 weeks 0 days (preterm premature rupture of membranes), spontaneous membrane rupture at any gestational age, preterm delivery at ≤34 weeks 0 days, nonintact hysterotomy (minimal uterine wall tissue between fetal membranes and uterine serosa, or partial or complete dehiscence at delivery), and chorioamniotic membrane separation. Risk factors were evaluated using χ2 and Wilcoxon tests and multivariable logistic regression. Results A total of 183 women were randomized: 91 to prenatal and 92 to postnatal surgery groups. Analysis of the complete cohort confirmed initial findings: that prenatal surgery was associated with an increased risk for membrane separation, oligohydramnios, spontaneous membrane rupture, spontaneous onset of labor, and earlier gestational age at birth. In multivariable logistic regression of the prenatal surgery group adjusting for clinical center, earlier gestational age at surgery and chorioamniotic membrane separation were associated with increased risk of spontaneous membrane rupture (odds ratio, 1.49; 95{\%} confidence interval, 1.01–2.22; and odds ratio, 2.96, 95{\%} confidence interval, 1.05–8.35, respectively). Oligohydramnios was associated with an increased risk of subsequent preterm delivery (odds ratio, 9.21; 95{\%} confidence interval, 2.19–38.78). Nulliparity was a risk factor for nonintact hysterotomy (odds ratio, 3.68; 95{\%} confidence interval, 1.35–10.05). Conclusion Despite the confirmed benefits of prenatal surgery, considerable maternal and fetal risk exists compared with postnatal repair. Early gestational age at surgery and development of chorioamniotic membrane separation are risk factors for ruptured membranes. Oligohydramnios is a risk factor for preterm delivery and nulliparity is a risk factor for nonintact hysterotomy at delivery.",
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T2 - obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery

AU - Johnson, Mark P.

AU - Bennett, Kelly A.

AU - Rand, Larry

AU - Burrows, Pamela K.

AU - Thom, Elizabeth A.

AU - Howell, Lori J.

AU - Farrell, Jody A.

AU - Dabrowiak, Mary E.

AU - Brock, John W.

AU - Farmer, Diana L

AU - Adzick, N. Scott

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N2 - Background The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal closure of myelomeningocele. The trial was stopped early at recommendation of the data and safety monitoring committee and outcome data for 158 of the 183 randomized women published. Objective In this report, pregnancy outcomes for the complete trial cohort are presented. We also sought to analyze risk factors for adverse pregnancy outcome among those women who underwent prenatal myelomeningocele repair. Study Design Pregnancy outcomes were compared between the 2 surgery groups. For women who underwent prenatal surgery, antecedent demographic, surgical, and pregnancy complication risk factors were evaluated for the following outcomes: premature spontaneous membrane rupture ≤34 weeks 0 days (preterm premature rupture of membranes), spontaneous membrane rupture at any gestational age, preterm delivery at ≤34 weeks 0 days, nonintact hysterotomy (minimal uterine wall tissue between fetal membranes and uterine serosa, or partial or complete dehiscence at delivery), and chorioamniotic membrane separation. Risk factors were evaluated using χ2 and Wilcoxon tests and multivariable logistic regression. Results A total of 183 women were randomized: 91 to prenatal and 92 to postnatal surgery groups. Analysis of the complete cohort confirmed initial findings: that prenatal surgery was associated with an increased risk for membrane separation, oligohydramnios, spontaneous membrane rupture, spontaneous onset of labor, and earlier gestational age at birth. In multivariable logistic regression of the prenatal surgery group adjusting for clinical center, earlier gestational age at surgery and chorioamniotic membrane separation were associated with increased risk of spontaneous membrane rupture (odds ratio, 1.49; 95% confidence interval, 1.01–2.22; and odds ratio, 2.96, 95% confidence interval, 1.05–8.35, respectively). Oligohydramnios was associated with an increased risk of subsequent preterm delivery (odds ratio, 9.21; 95% confidence interval, 2.19–38.78). Nulliparity was a risk factor for nonintact hysterotomy (odds ratio, 3.68; 95% confidence interval, 1.35–10.05). Conclusion Despite the confirmed benefits of prenatal surgery, considerable maternal and fetal risk exists compared with postnatal repair. Early gestational age at surgery and development of chorioamniotic membrane separation are risk factors for ruptured membranes. Oligohydramnios is a risk factor for preterm delivery and nulliparity is a risk factor for nonintact hysterotomy at delivery.

AB - Background The Management of Myelomeningocele Study was a multicenter randomized trial to compare prenatal and standard postnatal closure of myelomeningocele. The trial was stopped early at recommendation of the data and safety monitoring committee and outcome data for 158 of the 183 randomized women published. Objective In this report, pregnancy outcomes for the complete trial cohort are presented. We also sought to analyze risk factors for adverse pregnancy outcome among those women who underwent prenatal myelomeningocele repair. Study Design Pregnancy outcomes were compared between the 2 surgery groups. For women who underwent prenatal surgery, antecedent demographic, surgical, and pregnancy complication risk factors were evaluated for the following outcomes: premature spontaneous membrane rupture ≤34 weeks 0 days (preterm premature rupture of membranes), spontaneous membrane rupture at any gestational age, preterm delivery at ≤34 weeks 0 days, nonintact hysterotomy (minimal uterine wall tissue between fetal membranes and uterine serosa, or partial or complete dehiscence at delivery), and chorioamniotic membrane separation. Risk factors were evaluated using χ2 and Wilcoxon tests and multivariable logistic regression. Results A total of 183 women were randomized: 91 to prenatal and 92 to postnatal surgery groups. Analysis of the complete cohort confirmed initial findings: that prenatal surgery was associated with an increased risk for membrane separation, oligohydramnios, spontaneous membrane rupture, spontaneous onset of labor, and earlier gestational age at birth. In multivariable logistic regression of the prenatal surgery group adjusting for clinical center, earlier gestational age at surgery and chorioamniotic membrane separation were associated with increased risk of spontaneous membrane rupture (odds ratio, 1.49; 95% confidence interval, 1.01–2.22; and odds ratio, 2.96, 95% confidence interval, 1.05–8.35, respectively). Oligohydramnios was associated with an increased risk of subsequent preterm delivery (odds ratio, 9.21; 95% confidence interval, 2.19–38.78). Nulliparity was a risk factor for nonintact hysterotomy (odds ratio, 3.68; 95% confidence interval, 1.35–10.05). Conclusion Despite the confirmed benefits of prenatal surgery, considerable maternal and fetal risk exists compared with postnatal repair. Early gestational age at surgery and development of chorioamniotic membrane separation are risk factors for ruptured membranes. Oligohydramnios is a risk factor for preterm delivery and nulliparity is a risk factor for nonintact hysterotomy at delivery.

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KW - fetal spina bifida

KW - fetal therapy

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