The effects of synbiotic supplementation on blood pressure and other maternal outcomes in pregnant mothers with mild preeclampsia: a triple-blinded randomized controlled trial.

ABSTRACT

INTRODUCTION: Preeclampsia affects a significant percentage of pregnancies which is a leading cause of premature birth. Probiotics have the potential to affect inflammatory factors, and oxidative stress, which are linked to the development of preeclampsia. The study aimed to compare the effect of synbiotic and placebo on blood pressure and pregnancy duration as primary outcomes, and other pregnancy outcomes. METHODS: This study comprised 128 pregnant women with mild preeclampsia and gestational ages exceeding 24 weeks who were referred to the high-risk pregnancy clinic. It was a randomized, controlled, phase III, triple-blinded clinical experiment. The intervention and control groups were distributed to the participants at random. Intervention group received one oral synbiotic capsule, and control group received placebo daily until delivery. Based on gestational age at the time of diagnosis, preeclampsia was stratificated as early (< 34 weeks) or late (≥ 34 weeks). Data obtained from questionnaires, and biochemical serum factors were analyzed using SPSS software version 23 software. RESULTS: With the exception of the history of taking vitamin D3, there were no statistically significant variations in socio-demographic variables between the research groups. After the intervention, the means of systolic blood pressure (adjusted mean difference -13.54, 95% CI -5.01 to -22.07), and diastolic blood pressure (adjusted mean difference -10.30, 95% CI -4.70 to -15.90) were significantly lower in the synbiotic-supplemented group than in the placebo group. Compared to the placebo group, the incidence of severe PE (p < 0.001), proteinuria (p = 0.044), and mean serum creatinine level (p = 0.005) significantly declined in the synbiotic-supplemented group after the intervention. However, our analysis found no significant association for other outcomes. CONCLUSION: Based on our results, synbiotic had beneficial effects on some pregnancy outcomes. Further studies with larger samples are needed to verify the advantages of synbiotic supplementation for high-risk pregnancies, particularly with regards to higher doses, and longer intervention periods. TRIAL REGISTRATION IRCT20110606006709N20.