• David Simmons, Jincy Immanuel, William M Hague, Helena Teede, Christopher J Nolan, Michael J Peek, Jeff R Flack, Mark McLean, Vincent Wong, Emily Hibbert, Alexandra Kautzky-Willer, Jürgen Harreiter, Helena Backman, Emily Gianatti, Arianne Sweeting, Viswanathan Mohan, Joanne Enticott, N Wah Cheung, and TOBOGM Research Group.
• From Western Sydney University, Campbelltown, NSW (D.S., J.I.), Robinson Research Institute, University of Adelaide, Adelaide, SA (W.M.H.), Monash University, Melbourne, VIC (H.T., J.E.), Canberra Hospital and Australian National University (C.J.N.) and Australian National University (M.J.P.), Canberra, ACT, Bankstown-Lidcombe Hospital (J.R.F.), Blacktown Hospital (M.M.), Liverpool Hospital and University of New South Wales (V.W.), Nepean Clinical School, University of Sydney and Nepean Hospital (E.H.), the Department of Endocrinology, Royal Prince Alfred Hospital (A.S.), and Westmead Hospital (N.W.C.), Sydney, and the Department of Endocrinology, Fiona Stanley Hospital, Murdoch, WA (E.G.) - all in Australia; the Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna (A.K.-W., J.H.); the Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Orebro, Sweden (H.B.); and Dr. Mohan's Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, India (V.M).
• N. Engl. J. Med. 2023 Jun 8; 388 (23): 213221442132-2144.

BackgroundWhether treatment of gestational diabetes before 20 weeks' gestation improves maternal and infant health is unclear.MethodsWe randomly assigned, in a 1:1 ratio, women between 4 weeks' and 19 weeks 6 days' gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes (World Health Organization 2013 criteria) to receive immediate treatment for gestational diabetes or deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test [OGTT] at 24 to 28 weeks' gestation (control). The trial included three primary outcomes: a composite of adverse neonatal outcomes (birth at <37 weeks' gestation, birth trauma, birth weight of ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia), pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension), and neonatal lean body mass.ResultsA total of 802 women underwent randomization; 406 were assigned to the immediate-treatment group and 396 to the control group; follow-up data were available for 793 women (98.9%). An initial OGTT was performed at a mean (±SD) gestation of 15.6±2.5 weeks. An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the control group (adjusted risk difference, -5.6 percentage points; 95% confidence interval [CI], -10.1 to -1.2). Pregnancy-related hypertension occurred in 40 of 378 women (10.6%) in the immediate-treatment group and in 37 of 372 women (9.9%) in the control group (adjusted risk difference, 0.7 percentage points; 95% CI, -1.6 to 2.9). The mean neonatal lean body mass was 2.86 kg in the immediate-treatment group and 2.91 kg in the control group (adjusted mean difference, -0.04 kg; 95% CI, -0.09 to 0.02). No between-group differences were observed with respect to serious adverse events associated with screening and treatment.ConclusionsImmediate treatment of gestational diabetes before 20 weeks' gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass. (Funded by the National Health and Medical Research Council and others; TOBOGM Australian New Zealand Clinical Trials Registry number, ACTRN12616000924459.).Copyright © 2023 Massachusetts Medical Society.

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