A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening
Gestational diabetes mellitus (GDM) is common in pregnant women. It is associated with an increased risk of adverse maternal and perinatal outcomes. Although the universal recommendation for gestational diabetes screening is 24-28 weeks of gestation, there is a lack of scientific evidence about which of the two recommended screening approaches should be practised. The author Teresa A. Hillier and colleague (2021) published a study in the New England Journal of Medicine under the title “A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening”. The summary of the findings is below:
Objective:
To provide comparative evidence concerning maternal and neonatal outcomes for the one-step approach with the two-step approach for screening and diagnosis of gestational diabetes.
Method:
This pragmatic, randomized trial includes all pregnant women who received care in two health systems. The study compared one-step screening (i.e., a glucose tolerance test) with two-step screening (a glucose challenge test, followed, if positive, by an oral glucose tolerance test). Guidelines for the treatment of gestational diabetes were common for both screening groups. The main outcomes were a diagnosis of gestational diabetes, perinatal composite outcome (stillbirth, shoulder dystocia, bone fracture, neonatal death, or any arm or hand nerve palsy associated with birth injury), large-for-gestational-age infants, primary cesarean section, and gestational hypertension or preeclampsia.
Findings:
Investigators report that although double the number of women in the one-step group received a diagnosis of gestational diabetes, there were no significant differences in maternal and perinatal outcomes such as adverse perinatal outcomes, risks of large-for-gestational-age infants, primary cesarean section, or gestational hypertension or preeclampsia among all pregnant women. Additionally, not increased harm was associated with the diagnosis and treatment of gestational diabetes with the one-step approach. Women who did not undergo screening appeared to be worse than those in either of the screened groups.
Limitation:
The author acknowledges that the trial was extended as the lower adherence to the one-step approach could result in biased findings for the planned intention-to-treat analyses. Secondly, the sites used slightly different thresholds for the glucose challenge test to investigate whether women in the two-step group should receive an oral glucose tolerance test.
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