Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus

Ki vehet részt

• Women between 16 and 45 years of age with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines (one or more glucose concentrations of ≥5.6 mmol/l fasting or ≥7.8 mmol/l 2 hours after a standard 75g OGTT, and requiring pharmacological treatment)
• Overweight or obese (Booking BMI ≥25 kg/m2)
• Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery)

Ki nem vehet részt

• Previous diagnosis of diabetes outside pregnancy
• Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI
• Known allergy/hypersensitivity/intolerance to the active substance or excipients, or patients taking any medications which are contraindicated as per IMP SmPC
• HbA1c at booking >48 mmol/mol or ≥6.5% during current pregnancy (if available)
• Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR <60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results in the opinion of the responsible clinician or the CI
• Unwilling/unable to give written informed consent and comply with the requirements of the study protocol
• Multiple pregnancies (twins, triplets etc) in current pregnancy
• Congenital anomaly on ultrasound requiring fetal medicine input
• Not fluent in English and absence of interpreter or translation services (ie telephone translation services)
• Participating in another intervention study where the results could influence GDM-related endpoints, in the opinion of the responsible clinician or the CI, or participation in a CTIMP during current pregnancy