Metformin in pregnancy - ND

INTERVENTION: Trade Name: METFORAL*50CPR RIV 500MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Metformin CAS Number: 1115‐70‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: diabetes mellitus in pregnancy and iperinsulinism ; MedDRA version: 9.1 Level: LLT Classification code 10018209 Term: Gestational diabetes PRIMARY OUTCOME: Main Objective: To estimate if metformin is a treatment of women with gestational diabetes and if it delaies the manifestation Primary end point(s): the use of metformin in pregnancy Secondary Objective: To estimate the effect of this therapy on the foetus and on the maternal metabolism INCLUSION CRITERIA: pregravidic BMI 27 Kg/m2, increase of weight 0.5 Kg/week, previous getstional diabetes, diagnosis of PCOs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range