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IRCT20140525017827N13 IRCT 2021-11-20 Shiraz University of Medical Sciences Probiotic supplementation in pregnant women with intrauterine growth restriction Growing response to probiotic supplementation in pregnant women with intrauterine growth restriction 2021-11-22 anticipated 50 Complete https://irct.ir/trial/47656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The treatment allocation list is already designed on Block Balanced Randomization Method by the computer software (https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) .They are divided into two intervention or control groups by block sizes of 4 and 6 with an allocation ratio of 1:1. Any eligible patient will be given a 1 to 50 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B drug. The drug distributor doesn’t have a role in the treatment plan and data analysis. The patients, researcher, data analyzer are not aware of the type of treatment for each patient. Finally, the patients will be followed by their own codes, Blinding description: Probiotic and placebo have been administered in the similar bottles, so patients and researchers were unable to detect which one was Probiotic or placebo. Our nurse colleague in this study in hospital delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified. 3 Intrauterine growth restriction. Intervention 1: Intervention group: 25 of participant were treated with probiotic supplements of probiotic bacteria in the present study, including: Lactobacillus acidophilus 2CFU, Bifidobacterium bifidum , Lactophilus casei and Lactobacillus fermentum , which is prepared from Tehran Zig Tak Gene Company, twice a day. Diagnosis up to 28 weeks of pregnancy and aspirine 160 mg before sleep. Intervention 2: Control group: 25 patient will be received placebo made by the Faculty of Pharmacy of Shiraz university of medical sciences, twice per day and aspirine 160 mg before sleep. Yes - There is a plan to make this available What will be shared: Experimental results, ultrasound of patients in both groups, Statistical Results When: End of august 2022 To whom: healthcare professional- َacademic members of universities Conditions: An official request from the organization Where to obtain: To researchers responsible for responding to this plan Address: Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran Tel: +98-71-36128257,+98-36122285 Fax: 07136479830 postal code: 7193635899 How to obtain: Request to Vice-Chancellor for Research and Technology Affairsو Written request Coordinated by the ethics committee 2 months Comments:
public Sedighe Youosefi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 sedighe59yoosefi@gmail.com Shiraz University of Medical Sciences scientific Nasrin asadi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 nasadi2012@yahoo.ca Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 40 years Women's BMI should be in the range 19.5-29.9 Gravid 1 Mean UAPI in the study group > 2.53 Gestational age 11 to 13 weeks and six days uterine vascular resistance is high 18 years 40 years Female Liver and kidney disease Thyroid disorders Complete bed rest o36.5 Intrauterine growth restriction Treatment - Drugs Placebo Intervention group: 25 of participant were treated with probiotic supplements of probiotic bacteria in the present study, including: Lactobacillus acidophilus 2CFU, Bifidobacterium bifidum , Lactophilus casei and Lactobacillus fermentum , which is prepared from Tehran Zig Tak Gene Company, twice a day. Diagnosis up to 28 weeks of pregnancy and aspirine 160 mg before sleep Control group: 25 patient will be received placebo made by the Faculty of Pharmacy of Shiraz university of medical sciences, twice per day and aspirine 160 mg before sleep Total plasma antioxidant capacity (TAC). Timepoint: before starting medications and at 28 weeks. Method of measurement: Benzie and Strain methods by calorimetric method using Cusabio Biotech Co. Plasma Glutathione (GPX) Activity. Timepoint: Before starting medications and at 28 weeks. Method of measurement: Beutler method using Cusabio Biotech Co. Malondialdehyde (MDA). Timepoint: Before starting medications and at 28 weeks. Method of measurement: TBARS method. Lipid profiles of total cholesterol, HDL-C and triglyceride concentrations. Timepoint: Before starting medications and at 28 weeks. Method of measurement: Enzymatic method using Selectra II autoanalyzer. Inflammatory markers A. Inflammatory factor hs-CRP. Timepoint: Before starting medications and at 28 weeks. Method of measurement: ELISA device (immunoassay method). Nitric Oxide Inflammatory Marker Nitric Oxide Amount. Timepoint: Before starting medications and at 28 weeks. Method of measurement: The grease reaction is measured. Fasting blood sugar and insulin resistance. Timepoint: Before starting medications and at 28 weeks. Method of measurement: Glucose oxidase / peroxidase assay using commercially available kits. Shiraz University of Medical Sciences Approved 2019-05-19 Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)