DiGest: dietary intervention in gestational diabetes: a randomised controlled trial

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 380 人开始时间: 2020年4月28日最近更新: 2024年3月18日

试验速览

暂无简介。

•1. Women with GDM diagnosed at 20 to 30+6 weeks’ gestation using a standard clinical 75g OGTT in accordance with the guidelines of the National Institute of Health and Care Excellence (NICE)
•2. The NICE criteria state that the diagnosis of gestational diabetes will be made with one or more glucose concentrations during the OGTT of:
•2.1. >5.6 mmol/l in the fasting state
•2.2 >7.8 mmol/l 2 hours after 75 g glucose
•3. Pre-pregnancy overweight or obesity (BMI >25 kg/m2)
•4. A ultrasound-confirmed viable singleton pregnancy
•5. Planned antenatal care at the same centre or a different study centre throughout their pregnancy (ie: not planning to move away from the region before delivery)

•1. Evidence of multiple pregnancy on ultrasound
•2. Evidence of severe congenital anomaly on ultrasound
•3. Patient planning to terminate the pregnancy for any reason
•4. Significant pre-pregnancy diseases or comorbidities which increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (<1 year)
•5. Significant complications in the current pregnancy, such as threatened preterm labour, severe anaemia (Hb<8g/dl) or intra-uterine growth restriction (IUGR)
•6. Previous diagnosis of diabetes outside of pregnancy
•7. HbA1c at baseline of >48 mmol/mol
•8. Medications at the time of the OGTT which may interfere with the results of the OGTT (for example, steroids, immunosuppressants, certain antipsychotics)
•9. Estimated fetal weight <10th percentile at diagnosis of GDM
•10. Maternal requirement for a highly specialised diet (e.g. vegan)
•11. Maternal severe food allergy, for example, a nut allergy causing anaphylaxis
•12. Weight loss of >5% pre-pregnancy weight during pregnancy, prior to 28 weeks

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