Study of the effect of synbiotic supplementation on pregnancy outcomes in mothers with mild preeclampsia : A triple blind randomized controlled trial

1- Comparison of maternal outcomes in two groups of synbiotic and placebo recipients in women with mild preeclampsia. 2- Comparison of neonatal outcomes in two groups of synbiotic and placebo recipients in women with mild preeclampsia.

Controlled clinical trial, Phase 3, with two groups of parallel, three-blind

This study will be conducted in Al-Zahra and Taleghani hospitals in Tabriz. A non-involved research team member in the sample selection will determine the random allocation sequence using a computer program. Opaque envelopes in sealed numbered order will be used to hide the allocation. Eligible individuals will be randomly assigned to two groups of 64 individuals, first by simple method and then by blocking with block sizes of 4 and 6.

Inclusion criteria: 1) Detection of mild preeclampsia 2) Singleton pregnancy with live fetus 3) Gestational age more than 24 weeks 4) Women with first pregnancy (Nullipar) 5) Suitable maternal and fetal conditions for expectant management Exclusion criteria: 1) Women with cardiovascular disease 2) Women with renal and hepatic dysfunction 3) Severe and chronic hypertension 4) Gestational diabetes mellitus and chronic 5) History of probiotic susceptibility 6) Use of antibiotics over the past two weeks

Intervention group:The intervention group of the LactoCare synbiotic capsule made by the "Zist-takhmir" company, which contains the highest amounts of beneficial bacteria 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؛ The average length of pregnancy from diagnosis to delivery؛ Average birth weight at two groups.

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.

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.