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IRCT20191104045328N17 IRCT 2023-10-02 Arak University of Medical Sciences Effect of synbiotic supplement on placental uterine blood flow in patients with polycystic ovary syndrome The effect of synbiotic supplementation on placental uterine blood flow, lipid profile and glycemic index in pregnant women with polycystic ovary syndrome 2023-10-22 anticipated 98 Complete https://irct.ir/trial/72818 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced, Blinding description: For this, one group will receive Lactofem capsules and the other group will receive a starch capsule similar to Lactofem with the same duration and dosage. Therefore, the women participating in the study are not aware of the type of medicine. In addition, for blinding of the second type, the drugs are delivered by the supervisor in special envelopes to the obstetrics and gynecology assistant, and the supervisor gives them to the patients, and each patient They will be coded, so only the supervisor is aware of the type of medication and the relevant resident (the outcome assessor) is not aware of the patient's medication type. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: In the intervention group, patients will take one supplement capsule of Synbiotic Lactofem from Zisttakhmir company daily from the 28th week of pregnancy until the end of the 37th week. Intervention 2: Control group: In the placebo group, they receive placebo capsules with the same shape and dosage as the synbiotic group, produced by Zisttakhmir. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2024/01/20 to 2027/01/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: Academic researchers and university professors can request the use of data from Dr. Nazila Eskandari after contacting the relevant professor by message or email. Dr. Nazila Eskandari: Phone: 09123417159 Email: nazilaeskandari1@gmail.com Address: Arak, Ayatollah Taleghani Hospital, Hospital Education Vice-Chancellor How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Fatemeh Seidi
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3819691187 +98 86 3222 2003 fatemehseidi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Khadijeh Nasri
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3532 nasri-k@aums.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers of 28 and 37 weeks of pregnancy with polycystic ovaries referred to Arak Taleghani Hospital. Age 18-50 years Consent to participate in the study 18 years 50 years Female History of congenital disease History of chronic diseases such as diabetes, cancer, high blood pressure, liver or kidney failure, etc. History of intrauterine growth restriction or preeclampsia or pregnancy complications in previous pregnancies Having a special diet or taking anti-inflammatory and sugar-lowering supplements in the last 6 months E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: In the intervention group, patients will take one supplement capsule of Synbiotic Lactofem from Zisttakhmir company daily from the 28th week of pregnancy until the end of the 37th week. Control group: In the placebo group, they receive placebo capsules with the same shape and dosage as the synbiotic group, produced by Zisttakhmir. PI of the umbilical artery. Timepoint: in the 28th and 37th weeks of pregnancy. Method of measurement: Doppler ultrasound. Baby's birth weight. Timepoint: at birth. Method of measurement: scales. Apgar score. Timepoint: 1st and 5th minute of birth. Method of measurement: Apgar chart. Gestational age at delivery. Timepoint: At the time of delivery. Method of measurement: time of birth. PI uterine artery. Timepoint: in the 28th and 37th weeks of pregnancy. Method of measurement: Doppler ultrasound. Preeclampsia. Timepoint: Monitoring during pregnancy. Method of measurement: Clinical trials and examinations. Intrauterine growth restriction. Timepoint: Monitoring during pregnancy. Method of measurement: sonography. Fasting blood glucose. Timepoint: 28th and 37th weeks of pregnancy. Method of measurement: Laboratory. Oral glucose tolerance tests. Timepoint: 28th and 37th weeks of pregnancy. Method of measurement: Laboratory. Homeostatic Model Assessment for Insulin Resistance. Timepoint: 28th and 37th weeks of pregnancy. Method of measurement: Laboratory. Lipid profile. Timepoint: 28th and 37th weeks of pregnancy. Method of measurement: Laboratory. Arak University of Medical Sciences Approved 2022-11-20 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)