Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial
Trial Parameters
Brief Summary
This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.
Eligibility Criteria
Inclusion Criteria: * Over 18 years of age. * Able to provide informed consent. * Confirmed viable pregnancy on a nuchal translucency scan done between 11+0 and 13+6 weeks. * Singleton pregnancies. * An abnormal glucose metabolism determined by a blood test performed before 14 weeks, defined as FPG 5.1-6.9mmol/L and/or HbA1c 5.7-6.4%. Exclusion Criteria: * Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG≥7.0mmol/L, or HbA1c≥6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy. * Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan. * Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation. * Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental il