Randomized Controlled Trial

. 2016 Jan;39(1):122-9.

doi: 10.2337/dc15-1206. Epub 2015 Dec 1.

Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience

Georgeanna J Klingensmith¹, Laura Pyle², Kristen J Nadeau³, Linda A Barbour⁴, Robin S Goland⁵, Steven M Willi⁶, Barbara Linder⁷, Neil H White⁸; TODAY Study Group

Collaborators, Affiliations

Collaborators

TODAY Study Group:
S McKay, M Haymond, B Anderson, C Bush, S Gunn, H Holden, S M Jones, G Jeha, S McGirk, S Thamotharan, L Cuttler, E Abrams, T Casey, W Dahms, C Ievers-Landis, B Kaminski, M Koontz, S MacLeish, P McGuigan, S Narasimhan, M Geffner, V Barraza, N Chang, B Conrad, D Dreimane, S Estrada, L Fisher, E Fleury-Milfort, S Hernandez, B Hollen, F Kaufman, E Law, V Mansilla, D Miller, C Muñoz, R Ortiz, A Ward, K Wexler, Y K Xu, P Yasuda, L Levitt Katz, R Berkowitz, S Boyd, B Johnson, J Kaplan, C Keating, C Lassiter, T Lipman, G McGinley, H McKnight, B Schwartzman, S Willi, S Arslanian, F Bacha, S Foster, B Galvin, T Hannon, A Kriska, I Libman, M Marcus, K Porter, T Songer, E Venditti, R Goland, D Gallagher, P Kringas, N Leibel, D Ng, M Ovalles, D Seidman, L Laffel, A Goebel-Fabbri, M Hall, L Higgins, J Keady, M Malloy, K Milaszewski, L Rasbach, D M Nathan, A Angelescu, L Bissett, C Ciccarelli, L Delahanty, V Goldman, O Hardy, M Larkin, L Levitsky, R McEachern, D Norman, D Nwosu, S Park-Bennett, D Richards, N Sherry, B Steiner, S Tollefsen, S Carnes, D Dempsher, D Flomo, T Whelan, B Wolff, R Weinstock, D Bowerman, S Bristol, J Bulger, J Hartsig, R Izquierdo, J Kearns, R Saletsky, P Trief, P Zeitler, N Abramson, A Bradhurst, N Celona-Jacobs, J Higgins, M M Kelsey, G Klingensmith, K Nadeau, T Witten, K Copeland, E Boss, R Brown, J Chadwick, L Chalmers, S Chernausek, A Hebensperger, C Macha, R Newgent, A Nordyke, D Olson, T Poulsen, L Pratt, J Preske, J Schanuel, S Sternlof, J Lynch, N Amodei, R Barajas, C Cody, D Hale, J Hernandez, C Ibarra, E Morales, S Rivera, G Rupert, A Wauters, N White, A Arbeláez, D Flomo, J Jones, T Jones, M Sadler, M Tanner, A Timpson, R Welch, S Caprio, M Grey, C Guandalini, S Lavietes, P Rose, A Syme, W Tamborlane, K Hirst, S Edelstein, P Feit, N Grover, C Long, L Pyle, B Linder, S M Marcovina, J Harting, J Shepherd, B Fan, L Marquez, M Sherman, J Wang, M Nichols, E Mayer-Davis, Y Liu, J Lima, S Gidding, J Puccella, E Ricketts, R Danis, A Domalpally, A Goulding, S Neill, P Vargo, D Wilfley, D Aldrich-Rasche, K Franklin, C Massmann, D O'Brien, J Patterson, T Tibbs, D Van Buren, M Palmert, R Ratner, D Dremaine, J Silverstein

Affiliations

¹ Barbara Davis Center for Diabetes and Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
² The Biostatistics Center, George Washington University, Rockville, MD laura.pyle@ucdenver.edu.
³ Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
⁴ Department of Medicine, Division of Endocrinology, and Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Colorado School of Medicine, Aurora, CO.
⁵ Naomi Berrie Diabetes Center, Columbia University, New York, NY.
⁶ Department of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.
⁷ National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
⁸ Division of Endocrinology & Diabetes, Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO.

PMID: 26628417
PMCID: PMC4686849
DOI: 10.2337/dc15-1206

Randomized Controlled Trial

Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience

Georgeanna J Klingensmith et al. Diabetes Care. 2016 Jan.

. 2016 Jan;39(1):122-9.

doi: 10.2337/dc15-1206. Epub 2015 Dec 1.

Authors

Georgeanna J Klingensmith¹, Laura Pyle², Kristen J Nadeau³, Linda A Barbour⁴, Robin S Goland⁵, Steven M Willi⁶, Barbara Linder⁷, Neil H White⁸; TODAY Study Group

Collaborators

TODAY Study Group:
S McKay, M Haymond, B Anderson, C Bush, S Gunn, H Holden, S M Jones, G Jeha, S McGirk, S Thamotharan, L Cuttler, E Abrams, T Casey, W Dahms, C Ievers-Landis, B Kaminski, M Koontz, S MacLeish, P McGuigan, S Narasimhan, M Geffner, V Barraza, N Chang, B Conrad, D Dreimane, S Estrada, L Fisher, E Fleury-Milfort, S Hernandez, B Hollen, F Kaufman, E Law, V Mansilla, D Miller, C Muñoz, R Ortiz, A Ward, K Wexler, Y K Xu, P Yasuda, L Levitt Katz, R Berkowitz, S Boyd, B Johnson, J Kaplan, C Keating, C Lassiter, T Lipman, G McGinley, H McKnight, B Schwartzman, S Willi, S Arslanian, F Bacha, S Foster, B Galvin, T Hannon, A Kriska, I Libman, M Marcus, K Porter, T Songer, E Venditti, R Goland, D Gallagher, P Kringas, N Leibel, D Ng, M Ovalles, D Seidman, L Laffel, A Goebel-Fabbri, M Hall, L Higgins, J Keady, M Malloy, K Milaszewski, L Rasbach, D M Nathan, A Angelescu, L Bissett, C Ciccarelli, L Delahanty, V Goldman, O Hardy, M Larkin, L Levitsky, R McEachern, D Norman, D Nwosu, S Park-Bennett, D Richards, N Sherry, B Steiner, S Tollefsen, S Carnes, D Dempsher, D Flomo, T Whelan, B Wolff, R Weinstock, D Bowerman, S Bristol, J Bulger, J Hartsig, R Izquierdo, J Kearns, R Saletsky, P Trief, P Zeitler, N Abramson, A Bradhurst, N Celona-Jacobs, J Higgins, M M Kelsey, G Klingensmith, K Nadeau, T Witten, K Copeland, E Boss, R Brown, J Chadwick, L Chalmers, S Chernausek, A Hebensperger, C Macha, R Newgent, A Nordyke, D Olson, T Poulsen, L Pratt, J Preske, J Schanuel, S Sternlof, J Lynch, N Amodei, R Barajas, C Cody, D Hale, J Hernandez, C Ibarra, E Morales, S Rivera, G Rupert, A Wauters, N White, A Arbeláez, D Flomo, J Jones, T Jones, M Sadler, M Tanner, A Timpson, R Welch, S Caprio, M Grey, C Guandalini, S Lavietes, P Rose, A Syme, W Tamborlane, K Hirst, S Edelstein, P Feit, N Grover, C Long, L Pyle, B Linder, S M Marcovina, J Harting, J Shepherd, B Fan, L Marquez, M Sherman, J Wang, M Nichols, E Mayer-Davis, Y Liu, J Lima, S Gidding, J Puccella, E Ricketts, R Danis, A Domalpally, A Goulding, S Neill, P Vargo, D Wilfley, D Aldrich-Rasche, K Franklin, C Massmann, D O'Brien, J Patterson, T Tibbs, D Van Buren, M Palmert, R Ratner, D Dremaine, J Silverstein

Affiliations

¹ Barbara Davis Center for Diabetes and Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
² The Biostatistics Center, George Washington University, Rockville, MD laura.pyle@ucdenver.edu.
³ Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
⁴ Department of Medicine, Division of Endocrinology, and Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Colorado School of Medicine, Aurora, CO.
⁵ Naomi Berrie Diabetes Center, Columbia University, New York, NY.
⁶ Department of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.
⁷ National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
⁸ Division of Endocrinology & Diabetes, Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO.

PMID: 26628417
PMCID: PMC4686849
DOI: 10.2337/dc15-1206

Abstract

Objective: We evaluated pregnancy outcomes, maternal and fetal/neonatal, during the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study.

Research design and methods: The TODAY study was a randomized controlled trial comparing three treatment options for youth with type 2 diabetes. Informed consent included the requirement for contraception, including abstinence; this was reinforced at each visit. Following informed consent, self-reported data related to the mother's prenatal care and delivery and the infant's health were retrospectively collected. When permitted, maternal medical records and infant birth records were reviewed.

Results: Of the 452 enrolled female participants, 46 (10.2%) had 63 pregnancies. Despite continued emphasis on adequate contraception, only 4.8% of the pregnant participants reported using contraception prior to pregnancy. The mean age at first pregnancy was 18.4 years; the mean diabetes duration was 3.17 years. Seven pregnancies were electively terminated; three pregnancies had no data reported. Of the remaining 53 pregnancies, 5 (9.4%) resulted in early pregnancy loss, and 7 (13%) resulted in loss with inadequate pregnancy duration data. Two pregnancies ended in stillbirth, at 27 and 37 weeks, and 39 ended with a live-born infant. Of the live-born infants, six (15.4%) were preterm and eight (20.5%) had a major congenital anomaly.

Conclusions: Despite diabetes-specific information recommending birth control and the avoidance of pregnancy, 10% of the study participants became pregnant. Pregnancies in youth with type 2 diabetes may be especially prone to result in congenital anomalies. Reasons for the high rate of congenital anomalies are uncertain, but may include poor metabolic control and extreme obesity.

Trial registration: ClinicalTrials.gov NCT00081328.

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Figures

**Figure 1**
Breakdown of pregnancies reported by young women in the TODAY study. The shaded box represents the pregnancies on which results are reported herein.

See this image and copyright information in PMC

References

1. Centers for Disease Control and Prevention. Fast facts on diabetes: national diabetes fact sheet, 2011 [Internet], 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available from http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed 30 June 2014
1. Dabelea D, Mayer-Davis EJ, Saydah S, et al. .; SEARCH for Diabetes in Youth Study . Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA 2014;311:1778–1786 - PMC - PubMed
1. Macintosh MC, Fleming KM, Bailey JA, et al. . Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: population based study. BMJ 2006;333:177. - PMC - PubMed
1. Groen B, Links TP, van den Berg PP, et al. Similar adverse pregnancy outcome in native and nonnative Dutch women with pregestational type 2 diabetes: a multicentre retrospective study. ISRN Obstet Gynecol 2013;2013:361435. - PMC - PubMed
1. Barbour LA. Changing perspectives in pre-existing diabetes and obesity in pregnancy: maternal and infant short- and long-term outcomes. Curr Opin Endocrinol Diabetes Obes 2014;21:257–263 - PubMed

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Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience

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Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience

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