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Further implications from a pragmatic randomized clinical trial of gestational diabetes screening: per-protocol and as-treated estimates

Published:August 08, 2021DOI:https://doi.org/10.1016/j.ajog.2021.08.006
      In a recently published pragmatic clinical trial,
      • Hillier T.A.
      • Pedula K.L.
      • Ogasawara K.K.
      • et al.
      A pragmatic, randomized clinical trial of gestational diabetes screening.
      we found significantly higher incidence of diagnosed gestational diabetes mellitus (GDM) but no significant differences in primary perinatal outcomes with 1-step vs 2-step GDM screening. The published inverse probability weighted intent-to-treat (IPW-ITT) analyses provide the most robust and unbiased test of potential differences between the 2 methods, because they adjust for lower adherence to the 1-step method. Here, our objective is to newly report the results of per-protocol (PP) and as-treated (AT) analyses to further inform future study designs, meta-analyses, and clinical practice and address the questions raised by our recently published trial.
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