The Effect of Symbiotic Supplementation on Pregnancy Outcomes in Mothers with Mild Preeclampsia: A Randomized, Controlled, Three-Blind Clinical Trial
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Abstract Introduction: Preeclampsia affects 2-8% of all pregnancies and is the main cause of preterm birth. No immediate prevention method or treatment for preeclampsia has been formally proposed. Probiotics affect the inflammatory bio-inhibitors and oxidative stress that are involved in the mechanism of preeclampsia. The aim of this study was to determine the effect of synbiotic supplementation compared with placebo on maternal outcomes (Primary outcomes include: systolic and diastolic blood pressure, gestational age, secondary outcomes include: proteinuria, severe preeclampsia, antihypertensive drug use, normal delivery, rate of serious complications due to the disease (stroke, renal failure, insufficiency Hepatic, HELLP syndrome, intravascular coagulation, pulmonary edema), neonatal and fetal outcomes (Primary outcomes include: infant weight, secondary outcomes include: infant death, preterm birth, neonatal intensive care for more than 7 days, low birth weight, infant height and head circumference, Apgar score less than 7 in the fifth minute, use of Surfactants, intubation and mechanical ventilation, CPAP use and fetal death) in mothers with mild preeclampsia. Materials and Methods: This is a study of a randomized, controlled, phase 3, triple-blind, randomized clinical trial. The stratification were performed by gestational age at the time of diagnosis of mild preeclampsia (early preeclampsia (<34 weeks) or late (≥34 weeks). Initially, sampling was performed easy or accessible. The participants were 128 pregnant women over 24 weeks of gestation diagnosed with mild preeclampsia who had been referred to high risk pregnancy clinics. Participants were randomly divided into intervention and control groups using RAS (Random Allocation Software) allocation sequence, and received one lactocare oral synbiotic capsule with count more than 109 CFU (Colony-forming unit) or placebo daily from admission to delivery. Data were obtained from Demographic and Pregnancy-Maternity Questionnaire, Daily Medication and Complications Checklist, Pregnancy, Childbirth and Neonatal Information Questionnaire, Test Record Sheet, Blood Pressure Record Sheet, and Medication Side effect Checklist. Data were analyzed using independent t-test, chi-square, Fisher's exact test, ANCOVA, and logistic regression with SPSS software version 23. Results: There was no statistically significant difference between the studied groups in terms of individual- social characteristics, except for the history of vitamin D3 consumption. Systolic and diastolic blood pressure were significantly increased in the placebo group, but there were no significant changes in the synbiotic group. The difference between the mean systolic and diastolic blood pressure between the studied groups was statistically significant (P= 0.002 and P< 0.001, respectively). Synbiotic supplementation had no significant effect on increasing gestational age (P= 0.40) and birth weight (P= 0.14). Other pregnancy outcomes such as severe preeclampsia (001/0 > P), accidental proteinuria (P= 044/0), blood creatinine (P005/0 =), first minute Apgar score (033/0 P=) and surfactant use (P= 045/0) were significantly improved in the synbiotic group. But the other outcomes (Such as: taking antihypertensive drug, rate of normal delivery, rate of serious complications due to disease, infant death, preterm birth, hospitalization in NICU more than 7 days, low birth weight, height and head circumference of baby, Apgar score less than 7 in the fifth minute, intubation and mechanical ventilation, use of CPAP and fetal death) did not change significantly. Conclusion: Based on the results, consumption of probiotic/synbiotic supplementation in mothers with mild preeclampsia improves some pregnancy outcomes including hypertension, severe preeclampsia, renal factors, Apgar baby and the use of surfactant. Supplementation had no effect on other outcomes, and required further studies with higher sample size and Supplementation dose and longer duration of intervention with supplementation.