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IRCT201604013706N31 IRCT 2016-04-12 Research Deputy of Tabriz University of Medical Sciences Effect of probiotic yoghurt on level of blood glucose in obese and overweight pregnant women Effect of probiotic yoghurt on level of blood glucose in obese and overweight pregnant women: a randomized controlled trial 2016-05-01 anticipated 130 Complete https://irct.ir/trial/3819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 impaired blood glucose. Intervention 1: Intervention group: Probiotic yogurt (containing 109 Cfu Lactobacillus Acidophilus LA5 and Bifidobacterium Lactis BB12), 100g daily, from 24th weeks of gestation until delivery. Intervention 2: Control group: conventional yogurt, 100g daily, from 24th weeks of gestation until delivery.
public Hanieh Asgharian
Nursing & Midwifery Faculty, South shariatie Ave
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6969 haniehasgh1367@gmail.com Nursing & Midwifery Faculty, Tabriz University of medical science scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South shariati street,Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 414796969 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 20-22 weeks of pregnancy; FBS<92 mg/dl; BMI≥25; age≥ 18 years; able to read and write Exclusion criteria: multiple pregnancy; prior history of GDM; taking any medication likely to influence metabolism of glucose (in particular metformin, glucocorticoids or immunosuppressants); medical condition associated with altered glucose metabolism (in particular Cushing's syndrom/disease and hepatic cirrhosis); known major fetal abnormality; known regular ingestion of other probiotics; smoking; antibiotic intake during current pregnancy 18 years 50 years Female R73.0 Abnormal glucose tolerance test Prevention Prevention Intervention group: Probiotic yogurt (containing 109 Cfu Lactobacillus Acidophilus LA5 and Bifidobacterium Lactis BB12), 100g daily, from 24th weeks of gestation until delivery Control group: conventional yogurt, 100g daily, from 24th weeks of gestation until delivery Fasting blood glucose. Timepoint: Before the intervention, 4 weeks after intervention. Method of measurement: labratory assessment. Blood glucose level 1 hour after intaking 75g oral glucose. Timepoint: 4 weeks after intervention. Method of measurement: labratory assessment. Blood glucose level 2 hours after intaking 75g oral glucose. Timepoint: 4 weeks after intervention. Method of measurement: labratory assessment. Gestational diabetes. Timepoint: 4 weeks after intervention and after delivery. Method of measurement: Labratory Assessment. Peeclampsia. Timepoint: 37th weeks of pregnancy and after delivery. Method of measurement: clinical (blood preassure) & labratory (proteinuria) assessment. Preterm delivery. Timepoint: after delivery. Method of measurement: medical record assessment. Birth weight. Timepoint: at birth, 10 days after birth. Method of measurement: medical record assessment, measurment of weight 10-12 days after birth by the researcher. Macrosomia or Large for gestational age. Timepoint: after delivery. Method of measurement: based on birth weight. Neonatal death. Timepoint: 30 days after birth. Method of measurement: asking from participant (woman) via calling. Neonatal billirubine level. Timepoint: 3-5 days after delivery. Method of measurement: labratory assessment. Research Deputy of Tabriz University of Medical Sciences Approved 2016-03-07 Research deputy of Tabriz University of Medical Sciences 3rd floor, Centeral Building No 2, Tabriz University of Medical Science, Golgasht st., Tabriz Tabriz Iran (Islamic Republic of)