1. In this randomized controlled trial, the treatment of gestational diabetes before 20 weeks’ gestation was associated with a lower risk of adverse neonatal outcomes compared to no treatment.
2. There was no significant difference between treatment and no treatment with respect to maternal hypertension or neonatal lean body mass.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Gestational diabetes occurs when the human body is unable to make sufficient amounts of insulin, resulting in high blood glucose levels. The primary concern with gestational diabetes is an increased risk of both maternal and fetal adverse events. Specifically, an increased risk of large-for-gestational-age infants, shoulder dystocia, and birth trauma. The current recommendations for screening and treatment of gestational diabetes focus on the period of 24 to 28 weeks’ gestation. There is interest in testing earlier in pregnancy for pregnant individuals who may be at higher risk for gestational diabetes. Notably, robust data demonstrating its benefits are currently lacking. This multicenter, randomized controlled trial evaluated the maternal and fetal outcomes of screening and initiating treatment for gestational diabetes before 20 weeks’ gestation. The primary results of the analysis found that there was a marginal improvement in the incidence of adverse neonatal outcomes, such as respiratory distress. Though, there was no significant difference in maternal high blood pressure or neonatal lean body mass. The major limitation was the duration of follow-up and the definition of early gestational diabetes. Further, there was non-standardization of treatment approaches across the various centers, and the results of the study cannot be generalized to patients without risk factors for hyperglycemia. In summary, this was a positive study that provided evidence of the benefit of early screening and treatment of gestational diabetes.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: This was a randomized controlled trial evaluating the effect of starting treatment for gestational diabetes prior to 20 weeks’ gestation on maternal and fetal outcomes. The primary outcome of interest was the incidence of adverse neonatal events, pregnancy-related hypertension, and neonatal lean body mass. Adult women who had a singleton pregnancy and were between four and 19 weeks’ gestation with at least one risk factor for hyperglycemia were included. Women who met the criteria for gestational diabetes as determined by the World Health Organization criteria were included. Women who had preexisting diabetes, high fasting glucose level, a high two-hour glucose level, or contraindications to participation as determined by local investigators were excluded. In total, 802 participants were randomized in a 1:1 ratio to immediate treatment for gestational diabetes (n=406) or a no-treatment control group (n=396). The primary analysis of the results found that the incidence of adverse neonatal outcomes was significantly lower in the immediate-treatment group compared to the control group (adjusted risk difference, -5.6 percentage points; 95% Confidence Interval [CI], -10.1 to -1.2). There was no significant difference in outcomes as it pertained to pregnancy-related hypertension or neonatal lean body mass. Though,, there was a significant difference in the incidence of severe peroneal injury which was higher in the control group (adjusted mean difference, -2.8 percentage points; 95% CI, -4.1 to -1.5). Overall, this study found that treatment of gestational diabetes early in the gestational age lead to a marginal improvement in incidence of adverse neonatal outcomes compared to no treatment, with the major cause of this effect due to neonatal respiratory distress.
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