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IRCT20191202045571N1 IRCT 2020-07-17 Gorgan University of Medical Sciences The effect of betamethasone injection in pregnant women exposed to preterm labor The effect of betamethasone injection on maternal and neonatal outcomes in pregnant women with gestational age 34-37 weeks exposed to preterm labor in Sayyad Shirazi Hospital, Gorgan. 2019-12-22 anticipated 110 Complete https://irct.ir/trial/44053 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use the block randomization method to randomize subjects into groups that result in equal sample sizes. We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks A for intervention and B for placebo B A B A 2) B B A A 1) B A A B 4) A B B A 3) A A B B 6) A B A B 5), Blinding description: The randomization process will be performed without anyinterference of the people who involved in the study. The drug and the placebo will be prepared in similar packages without the possibility of identification. Based on the classification, The people entered in the study will receive their own coded packages based on the specified classification, and the results will be recorded separately based on the coding on the packages and specifications of the studing groups. At the end of the study, the analyzer will use the sample codes and coding instructions to access the nature of the groups for analysis and conclusion. 3 Preterm labor. Intervention 1: Intervention group: Group A (Betamethasone Intervention)Intervention Betamethasone 12 mg(Iran Hormone production) intramuscular injection , 2 doses ,Daily. Intervention 2: Control group: group B ( control group or placebo), 1 cc Normal Salin (Iran Hormone production) , intramascular injection, 2 doses , daily. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Use of data to complement research on the adverse effects of corticosteroids in pregnant women Where to obtain: Contact the author of the article responsible for the research project data. How to obtain: Contact the author of the article responsible for the research project data.Specify the type of results requested. Comments:
public Fakhere Taheri
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3220 2565 fakhere21@yahoo.com Gorgan University of Medical Sciences scientific Fakhere Taheri
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3220 2565 fakhere21@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Gestational age 34-37 weeks, Preterm labor symptoms between the ages of 34-37 weeks gestation Need for prenatal corticosteroid injection according to specialist's diagnosis Consent to participate in the study no limit no limit Female Cases of intrauterine growth retardation (IUGR) Congenital malformations Multiple pregnancies Placenta previa Maternal systemic diseases (diabetes, Cardiovascular and endocrine disease ) Receiving two doses of betamethasone before study Treatment - Drugs Placebo Intervention group: Group A (Betamethasone Intervention)Intervention Betamethasone 12 mg(Iran Hormone production) intramuscular injection , 2 doses ,Daily Control group: group B ( control group or placebo), 1 cc Normal Salin (Iran Hormone production) , intramascular injection, 2 doses , daily Incidence of diabetes and hyperglycemia in mothers. Timepoint: FBS and 2Hpp check 6 weeks after delivery for mothers and for infants up to one week later. Method of measurement: Laboratory measurements of FBS and 2Hpp. Incidence of respiratory distress syndrome in neonates. Timepoint: Neonatal Respiratory Distress Syndrome. Method of measurement: based on neonates clinical manifestation. Gorgan University of Medical Sciences Approved 2019-10-20 Ethics Committee of Golestan University of Medical Sciences Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex Gorgan Golestan Iran (Islamic Republic of)