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

Georgeanna J Klingensmith, Laura Pyle, Kristen J Nadeau, Linda A Barbour, Robin S Goland, Steven M Willi, Barbara Linder, Neil H White, TODAY Study Group
Author Information
  1. Georgeanna J Klingensmith: Barbara Davis Center for Diabetes and Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
  2. Laura Pyle: The Biostatistics Center, George Washington University, Rockville, MD laura.pyle@ucdenver.edu.
  3. Kristen J Nadeau: Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
  4. Linda A Barbour: 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. Robin S Goland: Naomi Berrie Diabetes Center, Columbia University, New York, NY.
  6. Steven M Willi: Department of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.
  7. Barbara Linder: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
  8. Neil H White: Division of Endocrinology & Diabetes, Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO.

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.

Associated Data

ClinicalTrials.gov | NCT00081328

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Grants

  1. U01-DK-61230/NIDDK NIH HHS
  2. UL1 RR024153/NCRR NIH HHS
  3. M01-RR00125/NCRR NIH HHS
  4. UL1 RR025780/NCRR NIH HHS
  5. M01 RR000069/NCRR NIH HHS
  6. M01 RR000036/NCRR NIH HHS
  7. U01 DK061242/NIDDK NIH HHS
  8. UL1 RR024992/NCRR NIH HHS
  9. UL1-RR-024139/NCRR NIH HHS
  10. UL1-RR-024989/NCRR NIH HHS
  11. M01 RR014467/NCRR NIH HHS
  12. U01-DK-61212/NIDDK NIH HHS
  13. UL1-RR-024992/NCRR NIH HHS
  14. UL1 TR000448/NCATS NIH HHS
  15. M01 RR000084/NCRR NIH HHS
  16. M01-RR00043-45/NCRR NIH HHS
  17. U01-DK-61239/NIDDK NIH HHS
  18. UL1 RR024139/NCRR NIH HHS
  19. UL1 RR024989/NCRR NIH HHS
  20. U01 DK061254/NIDDK NIH HHS
  21. M01-RR-00036/NCRR NIH HHS
  22. U01 DK061212/NIDDK NIH HHS
  23. UL1-RR-024153/NCRR NIH HHS
  24. M01-RR01066/NCRR NIH HHS
  25. M01 RR001066/NCRR NIH HHS
  26. U01-DK-61254/NIDDK NIH HHS
  27. U01 DK061230/NIDDK NIH HHS
  28. UL1 TR000439/NCATS NIH HHS
  29. UL1-RR-025758/NCRR NIH HHS
  30. M01 RR000043/NCRR NIH HHS
  31. UL1-RR-024134/NCRR NIH HHS
  32. UL1-RR-025780/NCRR NIH HHS
  33. UL1 TR001082/NCATS NIH HHS
  34. U01-DK-61242/NIDDK NIH HHS
  35. UL1 RR025758/NCRR NIH HHS
  36. M01-RR00069/NCRR NIH HHS
  37. M01-RR14467/NCRR NIH HHS
  38. M01 RR000125/NCRR NIH HHS
  39. U01 DK061239/NIDDK NIH HHS
  40. UL1 RR024134/NCRR NIH HHS
  41. M01-RR00084/NCRR NIH HHS

MeSH Term

Adolescent
Delivery, Obstetric
Diabetes Mellitus, Type 2
Female
Humans
Infant, Newborn
Patient Compliance
Pregnancy
Pregnancy Outcome
Pregnancy in Diabetics
Prenatal Care
Stillbirth

Word Cloud

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