December 03, 2015
2 min read

Pregnancy complications, miscarriage rates high among TODAY study participants

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Adolescent girls with type 2 diabetes who became pregnant while participating in the TODAY study experienced a high rate of pregnancy loss and complications, with one-quarter of pregnancies ending in miscarriage or stillbirth and one-fifth of live-born infants diagnosed with a major congenital anomaly, according to study findings presented at the World Diabetes Congress.

In an analysis of pregnancy rates and outcomes of TODAY study participants, the researchers also noted that, despite a universal recommendation for contraception or abstinence, one in 10 participating girls became pregnant and 4.8% of participants who became pregnant reported using contraception during the mean 3.8 years of follow-up.

 “The rates of congenital anomalies in adolescents with type 2 diabetes were 4 times higher than expected, based on pregnancies in adult women with diabetes,” Kristen Nadeau, MD, MS, associate professor of pediatric endocrinology at the University of Colorado Denver and Children's Hospital Colorado, told Endocrine Today. “These concerning pregnancy outcomes, coupled with the rising rates of type 2 diabetes in adolescents globally, are very worrisome.”

Nadeau, Georgeanna J. Klingensmith, MD, of the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine, and colleagues analyzed data from 452 girls aged 10 to 17 years with overweight or obesity participating in the TODAY study, a randomized controlled trial designed to assess the efficacy of treatment options for young adults with type 2 diabetes. Researchers randomly assigned participants to metformin therapy alone, metformin plus rosiglitazone therapy or metformin therapy plus an intensive lifestyle education program. Researchers specified that all female participants use acceptable birth control, including abstinence, as rosiglitazone is a class C pregnancy medication. Any participants who became pregnant were advised to stop medication and were referred for prenatal care; study outcomes were not tracked during pregnancy or lactation, but resumed after.

Researchers found that 46 girls (10.2%) had 63 pregnancies; the mean age at first pregnancy was 18.4 years; mean diabetes duration was 3.17 years. Seven girls subsequently terminated their pregnancies, and three pregnancies had no data reported.

Of the remaining 53 pregnancies, 14 resulted in pregnancy loss (26.4%), six in preterm delivery and 33 in full-term live births.

“Strikingly, among the 39 live births, there were eight (20.5%) with major congenital anomalies,” the researchers wrote. “These anomalies included four cardiac anomalies and four other anomalies (polycystic kidney disease, microcephaly, cleft palate and jejunal atresia).”

Researchers found no significant difference in the HbA1c levels closest to conception between girls who delivered healthy, full-term babies and those whose babies had congenital anomalies (mean 7.5% vs. mean 6.9%); researchers did not observe a significant difference in pregnancy outcome when stratified by maternal BMI. Among participants who experienced pregnnacy loss, 50% reported smoking vs. 29.6% of participants who had successful deliveries; however, the difference was not statistically significant.

Researchers noted that small sample size and a high prevalence of other maternal comorbidities make it difficult to explain the high rate of congenital anomalies.

“We need research into better ways to deliver preconception counseling that is developmentally and culturally appropriate for the adolescent type 2 diabetes population, so that unplanned pregnancy, especially in the setting of poor diabetes control, can be avoided,” Nadeau told Endocrine Today. “In addition, since our data did not point to obvious causes of the high rates of congenital anomalies, we also need to better understand the reasons for the high rates of congenital anomalies in these young women, in order to know what factors during pregnancy to target.”The research was also published in Diabetes Care. – by Regina Schaffer


Klingensmith GJ, et al. Presented at: World Diabetes Congress; Nov. 30 through Dec. 4; Vancouver.

Klingensmith GJ, et al. Diabetes Care. 2015;doi:10.2337/dc15-1206.

Disclosure: The researchers report no relevant financial disclosures.

Editor’s note: On Dec. 4, we updated the article to establish the correct discontinuation of medication. The Editors regret this error.