Treating prediabetes in the first trimester: A randomized controlled tiral. Roeder H.A., Moore T.R., Wolfson T., & Ramos G.A. 2017.
abstract   bibtex   
OBJECTIVE: In women with prediabetes (HbA1c\textgreater5.7% and/or fasting glucose \textgreater 92 mg/dL) in early pregnancy, we sought to determine if immediate treatment improved maternal and fetal outcomes. STUDY DESIGN: This RCTenrolled women with prediabetes at \textless 15+0 weeks (wks) gestation between 2013-2015. Participants were randomized to first trimester or third trimester treatment of hyperglycemia including nutrition counseling, glucose monitoring, and medications as needed. Subjects underwent a blinded 2-hour glucose tolerance test (GTT) between 24-28 wks to test for gestational diabetes (GDM). The infants were followed longitudinally post-delivery. Exclusion criteria were pregestational diabetes and multiple gestations. The primary outcome was the proportion of infants with neonatal umbilical cord C-peptide \textgreater 1.77 nmol (90th percentile (%)). Secondary outcomes were neonatal fat mass, infant World Health Organization weight-for length % at birth, 6 and 12 months of life, maternal gestational weight gain (GWG), and diagnosis with GDM on GTT. Mann-Whitney-Wilcoxon test and Fisher's exact test were used as appropriate. RESULTS: A total of 202 women were randomized; 45 dropped out prior to delivery leaving 157 for analysis (82 with first trimester and 75 with third trimester treatment). Baseline characteristics were similar between groups. There was no difference in C-peptide \textgreater90th% between groups (1.5% vs. 6.7% in first and third trimester groups respectively, p=0.19). There was also no difference in fat mass (361+/-155g vs 377+/-171g, p=0.91), weight-for length%at birth, 6 and 12 months (38 vs 35% p=0.46; 50 vs 45%, p=0.61; 61 vs 58% p=0.69 respectively), or macrosomia (1.6 vs 5.0%, p=0.35). Maternal GWG was 22.6+/-12.9 lbs and 23.9+/-11.2 lbs in the first and third trimester groups (p=0.88). GDM was diagnosed using the GTT in 19.0% of the cohort and did not differ between groups (13.8% vs 24.6%, p=0.173). CONCLUSION: In this population of women with prediabetes, treatment in the first trimester did not appear to significantly improve maternal, neonatal, or infant outcomes. Given comparable results in both first and third trimester groups, caution should be used in initiating an intensive GDM treatment protocol for women with the diagnosis of prediabetes in early gestation.
@misc{roeder_h.a._treating_2017,
	title = {Treating prediabetes in the first trimester: {A} randomized controlled tiral},
	abstract = {OBJECTIVE: In women with prediabetes (HbA1c{\textgreater}5.7\% and/or fasting glucose {\textgreater} 92 mg/dL) in early pregnancy, we sought to determine if immediate treatment improved maternal and fetal outcomes. STUDY DESIGN: This RCTenrolled women with prediabetes at {\textless} 15+0 weeks (wks) gestation between 2013-2015. Participants were randomized to first trimester or third trimester treatment of hyperglycemia including nutrition counseling, glucose monitoring, and medications as needed. Subjects underwent a blinded 2-hour glucose tolerance test (GTT) between 24-28 wks to test for gestational diabetes (GDM). The infants were followed longitudinally post-delivery. Exclusion criteria were pregestational diabetes and multiple gestations. The primary outcome was the proportion of infants with neonatal umbilical cord C-peptide {\textgreater} 1.77 nmol (90th percentile (\%)). Secondary outcomes were neonatal fat mass, infant World Health Organization weight-for length \% at birth, 6 and 12 months of life, maternal gestational weight gain (GWG), and diagnosis with GDM on GTT. Mann-Whitney-Wilcoxon test and Fisher's exact test were used as appropriate. RESULTS: A total of 202 women were randomized; 45 dropped out prior to delivery leaving 157 for analysis (82 with first trimester and 75 with third trimester treatment). Baseline characteristics were similar between groups. There was no difference in C-peptide {\textgreater}90th\% between groups (1.5\% vs. 6.7\% in first and third trimester groups respectively, p=0.19). There was also no difference in fat mass (361+/-155g vs 377+/-171g, p=0.91), weight-for length\%at birth, 6 and 12 months (38 vs 35\% p=0.46; 50 vs 45\%, p=0.61; 61 vs 58\% p=0.69 respectively), or macrosomia (1.6 vs 5.0\%, p=0.35). Maternal GWG was 22.6+/-12.9 lbs and 23.9+/-11.2 lbs in the first and third trimester groups (p=0.88). GDM was diagnosed using the GTT in 19.0\% of the cohort and did not differ between groups (13.8\% vs 24.6\%, p=0.173). CONCLUSION: In this population of women with prediabetes, treatment in the first trimester did not appear to significantly improve maternal, neonatal, or infant outcomes. Given comparable results in both first and third trimester groups, caution should be used in initiating an intensive GDM treatment protocol for women with the diagnosis of prediabetes in early gestation.},
	journal = {American Journal of Obstetrics and Gynecology},
	author = {{Roeder H.A.} and {Moore T.R.} and {Wolfson T.} and {Ramos G.A.}},
	year = {2017},
	keywords = {*first trimester pregnancy, *impaired glucose tolerance, C peptide, blood glucose monitoring, clinical protocol, clinical trial, controlled clinical trial, controlled study, counseling, diagnosis, fat mass, female, fetus, fetus outcome, gestational weight gain, glucose tolerance test, human, hyperglycemia, infant, macrosomia, major clinical study, newborn, nutrition, pregnancy diabetes mellitus, randomized controlled trial, rank sum test, single blind procedure, third trimester pregnancy, umbilical cord, world health organization}
}

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