Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

Women with early abnormal glucose metabolism (EAGM) , which is defined as fasting plasma glucose (FPG) 5.1-6.9 mmol/L and/or hemoglobin A1c (HbA1c) 5.7%-6.4% at before 14 weeks of gestation, will be recruited and randomized in a 1:1 ratio into the intervention or control group. The intervention will consist of a lifestyle intervention that comprises advice on diet, exercise, weight management and self-monitoring of blood glucose (SMBG) with feedback from healthcare professionals on results and insulin treatment if indicated. The educational session is delivered as an initial session following randomization followed by five follow-up sessions which will occur approximately every four months, either face-to-face during routine prenatal visits or via telephone consultation. Routine prenatal care will also be applied to the intervention group. Women in the control group will only receive routine prenatal care. Both groups will receive an OGTT test at 24-28 weeks of gestation unless insulin is needed before the OGTT test for suboptimally controlled blood glucose levels. Whether to continue the intervention depends on the OGTT results as women diagnosed with GDM or overt diabetes will continue intervention plus routine prenatal care until delivery while those will normal OGTT result will pause interventions and follow the routine prenatal care only until delivery. The primary outcome of our trial will be a composite of neonatal outcome including large-for-gestational age and preterm birth.

• Pregnancy-related hypertensive disorders [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Gestational diabetes mellitus [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Gestational hypertension [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Preeclampsia [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Eclampsia [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Prescription of hypoglycaemic drug [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Preeclampsia requiring delivery before 37 weeks [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Total gestational weight gain [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Mode of birth [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Primary caesarean [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Large-for-gestational age [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]
• Preterm birth at <37 weeks of gestation [Срок оценки: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.]