]>
IRCT20190716044229N1 IRCT 2020-02-06 Oroumia University of Medical Sciences Impact of metformin on pregnancy outcomes in overweight women Evaluating the effect of Metformin administration on pregnancy outcomes in healthy overweight pregnant women 2019-07-16 anticipated 350 Complete https://irct.ir/trial/41134 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will be performed by an epidemiologist, via employing specialized software. Blocks A and B, each, shall only include patients form the intervention or control groups, Blinding description: At the start of the study, each patient will be assigned an individual code, which will be used for identification thereafter. These codes will be also be used for randomization and shall only be available and accessible to the individual in charge of coding and grouping the subjects. Intervention and control groups will remain unrevealed to both physician and patient until the conclusion of the study. 3 Pregnancy outcomes in overweight pregnancies. Intervention 1: Intevention group:oral metformin500 mgr/twice a day,( manufactured in Iran) from 12-16week until delivery. Intervention 2: Control group:placebo with chemical composition:(Starch200mg/Cellulose acetate 150 mg/Hypermellose50mg/Sodium lauryl sulfate50mg/Manesium stearate50mg).Round and white in Metformin size.construction of Urmia School of Pharmacy.Laboratory of Pharmaceuticals.twice a dayfrom 12-16 week until delivery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project, the decision will be made.
public Samira Esmaili
Motahari Hospital, Kashani Street
Urmia Iran (Islamic Republic of) 04412234125 +98 44 3232 7077 samiraesmaili2019@yahoo.com Oroumia University of Medical Sciences scientific Samira Esmaili
Kashani street, Motahari Hospital
Urmia Iran (Islamic Republic of) 04412234125 +98 44 3232 7077 samiraesmaili2019@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Maternal age >=16 years Singelton pregnancy Body mass index: 25<=BMI<30 Negative history of Diabetes Mellitus Negative history of previous medical conditions Gestational age between 12 & 16 weeks 16 years no limit Female Multiple gestation Positive history of general medical conditions (e.g. diabetes) BMI<25 or >=30 Prevention Placebo Intevention group:oral metformin500 mgr/twice a day,( manufactured in Iran) from 12-16week until delivery Control group:placebo with chemical composition:(Starch200mg/Cellulose acetate 150 mg/Hypermellose50mg/Sodium lauryl sulfate50mg/Manesium stearate50mg).Round and white in Metformin size.construction of Urmia School of Pharmacy.Laboratory of Pharmaceuticals.twice a dayfrom 12-16 week until delivery. Frequency of fetal macrosomia. Timepoint: Post-partum. Method of measurement: Neonatal weighing scale. Incidence of gestational diabetes mellitus. Timepoint: From gestational age 24 weeks onward. Method of measurement: Three hour glucose tolerance test. Incidence of preeclampsia. Timepoint: Fromgestational age 20 weeks onward. Method of measurement: Measurement of blood pressure and relevant laboratory analyses. Gestational weight gain monitoring. Timepoint: From baseline until delivery. Method of measurement: Weighing scale. Oroumia University of Medical Sciences Approved 2019-07-16 Ethics commitee of Urmia University of Medical Sciences Orjhans Street, Resalat Blvd, Urmia , Iran Urmia West Azarbaijan Iran (Islamic Republic of)