Effectiveness of a lifestyle intervention for pregnant women with abnormal glucose metabolism in early pregnancy (EAGM): protocol for a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial

Universal screening for hyperglycaemia in women without pregestational diabetes in China has led to a significant rise in the detection of abnormal glucose metabolism in early pregnancy (EAGM), defined as elevated fasting blood glucose (FPG, 5.1–6.9 mmol/L or 92–124 mg/dL) and/or haemoglobin A1c (HbA1c, 5.7%-6.4% or 41–47 mmol/mol) levels in the first trimester (< 14 weeks' gestation). EAGM is correlated with adverse pregnancy outcomes. However, whether early treatment can improve maternal and neonatal outcomes remains unclear. We present a protocol (V1.0, date August 15, 2024) for the EAGM trial, which is a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial in China. Eligible pregnancies with EAGM will be recruited from 17 hospitals. Participants (N = 3430) will be randomly allocated in a 1:1 ratio to the intervention group or the control group. The intervention group will begin early lifestyle intervention combined with routine prenatal care from < 15 weeks' gestation, while the control group will receive routine prenatal care alone. All participants will undergo an oral glucose tolerance test at 24–28 weeks' gestation, and whether to continue the intervention will depend on the test result. The primary outcome is a composite neonatal outcome of large-for-gestational-age and preterm birth at < 37 weeks' gestation. The EAGM trial is the first large-scale randomised controlled trial in China designed to evaluate the effectiveness of early lifestyle intervention for pregnant women with EAGM, identified by elevated HbA1c and/or FPG before 14 weeks' gestation. The findings are anticipated to provide high-quality evidence to guide future screening strategies and clinical management of early hyperglycaemia in pregnancy. ClinicalTrials.gov: NCT06767722. Registered 10 January 2025.