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IRCT20110606006709N20 IRCT 2019-09-25 Tabriz University of Medical Sciences The effect of probiotic supplementation on pregnancy outcomes in mothers with mild preeclampsia Study of the effect of synbiotic supplementation on pregnancy outcomes in mothers with mild preeclampsia : A triple blind randomized controlled trial 2019-10-22 anticipated 128 Complete https://irct.ir/trial/39930 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned into two groups of recipients of training or control using random blocking method and blocks of size 4 and 6 using Random Allocation Software (RAS) with a 1: 1 assignment ratio by the person not involved in the research. To conceal the allocation, opaque envelopes with sample numbers will be provided and numbered. Preparation of envelopes and sequence generation will be done by a person not involved in the research, Blinding description: In this study, The drug and the placebo will be prepared by the same pharmaceutical company in identical shape, color and smell. participants, researchers, medical staff (doctors, nurses, etc.) who are responsible for patient care, data collection officers and those who evaluate the outcome will not be informed about the drug type. To number of samples, large envelopes will be provided and flaccons will be placed inside the envelopes. Each packet will be assigned a number from 1 to 128 numbers. The envelopes are uniform, sealed, opaque and contain 14 capsules. And preparing them according to the allocation sequence will be done by the person not involved in the research. 3 mild preeclampsia. Intervention 1: Intervention group:The intervention group of the LactoCare synbiotic capsule made by the "Zist-takhmir" company, which contains the highest amounts of beneficial bacteria (lactobacilli, bifidobacteria and streptococcus), along with peribiotic fructologosaccharide (contributing to the growth and activity of probiotics). Intervention 2: Control group: Participants in this group will receive a placebo capsule quite similar to the synbiotic capsule. 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 Rouhina Movaghar
Faculty of Nursing and Midwifery, South Shariaty street
TAbriz Iran (Islamic Republic of) 5155884818 +98 41 3476 9372 Rouhin66@gmail.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
Faculty of Nursing & Midwifery, South Shariati street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 1477 2699 mshahnazi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant women with mild preeclampsia singleton pregnancy with live fetus Gestational age more than 24 weeks Women with first pregnancy (Noliparus) Suitable maternal and fetal conditions for expectant management 18 years 45 years Female Women with cardiovascular disease Women with renal and hepatic dysfunction Extreme and chronic hypertension Gestational diabetes mellitus and chronic History of probiotic susceptibility Use of antibiotics over the past two weeks O14.0 Mild to moderate pre-eclampsia Treatment - Drugs Placebo Intervention group:The intervention group of the LactoCare synbiotic capsule made by the "Zist-takhmir" company, which contains the highest amounts of beneficial bacteria (lactobacilli, bifidobacteria and streptococcus), along with peribiotic fructologosaccharide (contributing to the growth and activity of probiotics). Control group: Participants in this group will receive a placebo capsule quite similar to the synbiotic capsule. Mean systolic and diastolic blood pressure. Timepoint: Blood pressure will be measured before, during and after the study. Method of measurement: Measurement of blood pressure by ISOMED mercuric barometric device. Mean duration of pregnancy from diagnosis to delivery. Timepoint: A the time of delivery. Method of measurement: Duration of pregnancy by calculating LMP or first trimester ultrasound. Mean of newborn weight at birth. Timepoint: A the time of delivery. Method of measurement: Measurement of birth weight by SECA scales. Detection of severe preeclampsia. Timepoint: During the study. Method of measurement: Criteria for the diagnosis of severe preeclampsia in the questionnaire. Tabriz University of Medical Sciences Approved 2019-08-19 Ethics Committee of Tabriz University of Medical Sciences South Shariati Street, College of Nursing and Midwifery Tabtiz East Azarbaijan Iran (Islamic Republic of)