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IRCT2016041317827N1 IRCT 2016-04-13 Vice Chancellor Of Research, Shiraz University of Medical Sciences Efficacy of Glibanclamide on Gestational diabetes and outcome of pregnancy A randomized clinical trial on comparison of efficacy of Glibanclamide and insulin on Gestational Diabetes and outcome of pregnancy 2015-01-21 anticipated 80 Other https://irct.ir/trial/16311 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Gestational Diabetes. Intervention 1: Control group: Insulin will be started , if FBS or 2hpp glucose levels are not control (FBS>95/dl and 2hpp>120mg/dl) respectively by diet control and exercise. 40 patient (group A) will be received Insulin (NPH or regular or both). The starting dose of Insulin is according to mean of their blood glucose. Intervention 2: Intervention group: 40 patients (group B) will be Glibenclamide starting with lowest requiring dose 1.25 mg (1/4 tab 5 mg) and will be increased by 1.5-2.50 mg weekly till reaching 15 mg.
public Lida Tahamtani
Zand Avenue
Shiraz Iran (Islamic Republic of) +98 71 3233 2365 Lida.tahamtani87@gmail.com Shiraz University of Medical Sciences scientific Nasrin Asadi
Khalili Avenue
Shiraz Iran (Islamic Republic of) +98 71 3628 1591 nasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Maternal age 20-40 years old; singleton pregnancy; gestational age and diagnosis of gestational diabetes will be given during pregnancy; healthy mothers with no renal diseases liver diseases and overt diabetes. Exclusion criteria: If the blood glucose is not controlled by the does of 15 mg glibanclamid they will be shifted to Insulin and will be excluded the study. 20 years 40 years Female Z35.- high-risk pregnancy Treatment - Drugs Treatment - Drugs Control group: Insulin will be started , if FBS or 2hpp glucose levels are not control (FBS>95/dl and 2hpp>120mg/dl) respectively by diet control and exercise. 40 patient (group A) will be received Insulin (NPH or regular or both). The starting dose of Insulin is according to mean of their blood glucose. Intervention group: 40 patients (group B) will be Glibenclamide starting with lowest requiring dose 1.25 mg (1/4 tab 5 mg) and will be increased by 1.5-2.50 mg weekly till reaching 15 mg. FBS & 2hpp. Timepoint: 4 time per day: over night fast and 2 hour post parandial diet (braekfast, lunch and dinner). Method of measurement: will be measured once a week by obestricians and twice weekly by the patients at home using Glucometer. Vice Chancellor Of Research, Shiraz University of Medical Sciences Approved 2014-02-24 Ethics Cmmittee of Shiraz University of Medical Sciences Zand Avenue Shiraz Iran (Islamic Republic of)