Probiotic supplementation during pregnancy and risk of gestational diabetes: A real-world pharmacoepidemiological study in a high-risk Bulgarian cohort
Authors/Creators
- 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Medical University of Plovdiv, Plovdiv, Bulgaria|Clinic of Obstetrics and Gynecology, "St. George University Hospital", Plovdiv, Bulgaria
- 2. Department of Healthcare Management, Faculty of Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria
Description
Background: The role of probiotic supplementation in the prevention of gestational diabetes mellitus (GDM) remains controversial, with conflicting evidence from randomized trials and observational studies. Despite increasing use in pregnancy, real-world data, particularly in high-risk populations, is limited.
Aim: To evaluate the association between probiotic supplementation and the development of GDM in a high-risk Bulgarian population and to identify key maternal predictors.
Methods: A prospective observational study was conducted including 946 pregnant women. Risk stratification was performed at 11–13 + 6 gestational weeks using an anamnestic screening model. Probiotic supplementation was recorded as a non-randomized exposure reflecting routine clinical practice. GDM was diagnosed at 24–28 weeks using a 75 g oral glucose tolerance test. Multivariable logistic regression was applied to assess independent predictors.
Results: GDM developed in 8.35% of participants, while 11.95% received probiotic supplementation. Among high-risk women, GDM occurred more frequently in women receiving probiotic supplementation compared to non-users (25% vs. 13.67%, p = 0.0095). However, probiotic supplementation was more common in women with higher baseline risk. Independent predictors of GDM included previous GDM (odds ratio [OR] 32.0), chronic hypertension (OR 6.81), and maternal body mass index (BMI) and age. Probiotic supplementation was also associated with GDM (OR 4.97), likely reflecting confounding by indication. No significant effect on gestational weight gain was observed.
Conclusion: In this real-world cohort, probiotic supplementation was associated with a higher observed incidence of GDM; however, this relationship is most likely explained by underlying risk differences rather than a causal effect. Maternal metabolic factors remain the primary determinants of GDM. These findings highlight the need for cautious interpretation of observational associations and for well-designed randomized trials with standardized probiotic formulations.
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