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IRCT2013102315045N2 IRCT 2014-04-19 Vice Chancellor for Research, Kashan University of Medical Sciences and Health Service Glibenclamide effect on maternal and neonatal outcomes in women with gestational diabetes Effect of glibenclamide in women with gestational diabetes on maternal and neonatal outcomes 2013-03-20 anticipated 278 Complete https://irct.ir/trial/14454 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Gestational diabet. Intervention 1: In the glibenclamide group, patients will take 1.25 mg oral tablet glibenclamid, once daily and If need, it will increase three days to reach the maximum daily 20 mg.If glibenclamide reach to maximum dose and after 2 weeks, the blood sugar level was not normal, the patient will be treated with insulin. Intervention 2: In insulin group, treated will be start with 0.2 U/kg insulin twice daily injections subcutaneously. If needed, it will increase every 3 days to achieve normal levels of blood sugar. The patient's blood sugar will be measured 4 times daily (fasting, 2 hours after breakfast, two hours after lunch and 2 hours after dinner).
public Dr.Tayebe Ghasemi
5th of Qotb –e Ravandi Blvd. P.O., Kashan, IRAN
Kashan Iran (Islamic Republic of) 8715988141 +98 36 1555 0021 qasemi-ta@kaums.ac.ir Kashan University of Medical Sciences, Faculty of Medicine scientific Dr. Mitra Behrashi
5th of Qotb –e Ravandi Blvd. P.O., Kashan, IRAN
Kashan Iran (Islamic Republic of) 8715988141 +98 36 1446 0180 َAR-behrashi2006@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: female age between 18 to 45 years; singleton pregnancy; no history of diabetes before pregnancy; gestational age between 11-33 weeks Exclusion criteria: premature rupture of membrane; severe infectious diseases; cardiovascular diseases; acute respiratory failure; hematological disease; renal disease; liver disease 18 years 45 years Female 024.9 Diabetes mellitus in pregnancy, unspecified Treatment - Drugs Treatment - Drugs In the glibenclamide group, patients will take 1.25 mg oral tablet glibenclamid, once daily and If need, it will increase three days to reach the maximum daily 20 mg.If glibenclamide reach to maximum dose and after 2 weeks, the blood sugar level was not normal, the patient will be treated with insulin. In insulin group, treated will be start with 0.2 U/kg insulin twice daily injections subcutaneously. If needed, it will increase every 3 days to achieve normal levels of blood sugar. The patient's blood sugar will be measured 4 times daily (fasting, 2 hours after breakfast, two hours after lunch and 2 hours after dinner). Birth Mother Trauma. Timepoint: Immediately after delivery. Method of measurement: Observation. Fetal anomaly. Timepoint: Immediately after delivery. Method of measurement: Observation. APGAR score. Timepoint: APGAR score 1and 5 minute after birth. Method of measurement: Observation and examination. Birthweight and birthweight percentiles. Timepoint: Immediately after delivery. Method of measurement: Scales and calculate percentile. Blood Sugar. Timepoint: From one half hour up to 3 hours. Method of measurement: Blood test. Blood calcium. Timepoint: One week after birth. Method of measurement: Blood test. Neonatal icterus. Timepoint: One week after birth. Method of measurement: Blood sugar. Shoulder dystocia. Timepoint: In the delivery room. Method of measurement: Observation. Perinatal death. Timepoint: ّFrom the second half of gestation to 28 days after birth. Method of measurement: Follow the samples and study their documents. Respiratory distress. Timepoint: Immediately to 4 hours after birth. Method of measurement: Observation and examination of newborn. Method of delivery. Timepoint: Date of Birth. Method of measurement: Observation. Birth Mother Trauma. Timepoint: During and after childbirth. Method of measurement: Observation. Maternal hypoglycemia. Timepoint: Once every three days until it becomes normal and then 4 times a day every week until delivery. Method of measurement: Blood glucose testing in the Shabih Khani hospital laboratory. Preeclapsia. Timepoint: ّFrom the second half of pregnancy up to 24 hours after birth. Method of measurement: Blood pressure measurement, urinalysis, and clinical symptoms examination. Need to be admitted to the neonatal intensive care unit. Timepoint: From birth until one week after delivery. Method of measurement: Follow up with the call and physical exam in infants hospitalized. Vice Chancellor for Research, Kashan University of Medical Sciences and Health Service Approved 2013-08-26 Kashan University of Medical Sciences, vice chancellor for reaserch 5th of Qotb5th of Qotb –e Ravandi Blvd., Kashan, IRAN Kashan Iran (Islamic Republic of)