The effect of synbiotic supplementation on placental uterine blood flow, lipid profile and glycemic index in pregnant women 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

The present study is a clinical trial with a control group, with parallel groups, double-blind, randomized (using block randomization), phase 3 on 98 patients.

In this double-blind randomization clinical trial, pregnant women with polycystic ovaries will be divided into two equal intervention and placebo groups by means of block randomization. In the intervention group, the patients will take one Lactofem synbiotic supplement capsule daily from the 28th week of pregnancy to the end of the 37th week, and in the placebo group, they will receive the placebo capsule. Finally, the two groups are compared in terms of outcomes.

Conditions for inclusion in the study: pregnant mothers in the 28th and 37th weeks of pregnancy with polycystic ovaries referred to Arak Taleghani Hospital; age 18-50 years; Consent to participate in the study Conditions for not entering the study: history of congenital disease; History of pregnancy complications in previous pregnancies; Having a special diet or taking anti-inflammatory and sugar-lowering supplements in the last 6 months

In the intervention group, patients will take one supplemental capsule of Synbiotic Lactofam from Zisttakhmir company daily from the 28th week of pregnancy until the end of the 37th week, and in the placebo group, they will receive a placebo capsule with the same shape and dosage as the synbiotic group produced by Zisttakhmir company.

Uterine and umbilical artery PI, birth weight, Apgar score at birth (first and fifth minutes), gestational age at delivery, preeclampsia, intrauterine growth restriction, fasting blood glucose, OGTT, lipid profile, HOMA index

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.

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.

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.

Access will be from 2024/01/20 to 2027/01/20 for 3 years.

University researchers

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.

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

Letter writing should be done with professors and universities.