Abstract

Background: Women with gestational diabetes mellitus (GDM) have excessive fetus growth weeks earlier than the recommended screening period, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring. This trial aimed to investigate if early screening and intervention could alter pregnancy outcomes, compared to the standard group. Methods: We conducted an open-label randomized controlled trial in singleton pregnant women at National Taiwan University Hospital from 2018 to 2021. GDM is diagnosed by 75g 2-hour oral glucose tolerance tests at 18-20 weeks of gestational age for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria. The primary outcome is a composite measure of pregnancy outcomes, including primary cesarean section, birth weight >90th percentile, neonatal hypoglycemia, cord serum C-peptide >90th percentile, gestational hypertension, preeclampsia and birth trauma. Results: Total 967 subjects were enrolled, including 483 subjects in the early-screening group and 484 subjects in the standard-screening group. Primary outcome was not statistically different between the two groups (early-screening group, 34.74%; standard-screening group 30.75%, p=0.20). There was also no significant difference in each individual outcome of the primary outcome between two groups except neonatal hypoglycemia, which was significantly higher in the standard-screening group than in the early-screening group (4.14% vs. 1.71%, p=0.0278). Conclusions: Early screening and intervention of GDM by the one-step method does not improve pregnancy outcomes as compared to standard practice. Disclosure C. Kuo: None. S. Lin: None. M. Lin: None. C. Lee: None. C. Chang: None. Y. Chang: None. Y. Tai: None. S. Chen: None. I. Yen: None. K. Fan: None. C. Hsu: None. K. Huang: None. W. Hsu: None. J. Kang: None. H. Li: None.

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