The trial will compare the influence of treatment with ursodeoxycholic acid (UDCA) compared to placebo on glycaemic control (primary outcome) in women with GDM after a positive diagnosis at 24-28 weeks of gestation. The investigators will evaluate maternal and fetal lipid and glucose metabolism. Neonatal health outcomes will also be studied, including the rate of LGA. UDCA is used to treat the commonest liver disease of pregnancy, intrahepatic cholestasis of pregnancy (ICP), and has good safety data to support its use in pregnancy 52-57 ., it means, no studies reported any increase in adverse outcomes associated with UDCA treatment. It is noteworthy that in the largest study 52, 8 serious adverse events were reported, 6 of which were in the placebo group, and none were considered to be related to the trial intervention. There were 72 adverse events: 31 in the ursodeoxycholic acid group and 41 in the placebo group. The same number of patients in each group (n=10) reported adverse events related to gastrointestinal disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
113
Administration of 500 mg of ursodeoxycholic acid (UDCA) /day
Administration of 500 mg of placebo /day
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Maternal fasting glucose concentration at 36 weeks
aiming to maintain all capillary glucose levels between 3.9-7.8mmol/l (70 - 140 mg/dL). The specific pre- and post-meal self-monitored blood glucose (SMBG) targets are ≤5.3mmol/L before breakfast (95 mg/dL), ≤7.8mmol/L 1-hr post meal (140 mg/dL) and ≤6.7mmol/L (120 mg/dL) 2-hr post meal.
Time frame: Up to 36 weeks
Proportion of women requiring insulin treatment
Number of women with insuline treatment
Time frame: Up to 36 weeks
Proportion of delivery type
Mode of delivery (rates of primary \& repeat CS, elective \& emergency
Time frame: Up to 40 weeks
Gestational age at delivery, frequency of preterm delivery
Age of patient
Time frame: Up to 40 weeks
Infant birth weight
Weight in kg
Time frame: Up to 40 weeks
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