The Effect of a Vaginal Probiotic Capsule on Prolonging Latency Period from Rupture of Membranes to Delivery At 24th To 32th Weeks of Pregnancy: A Randomized Clinical Trial

Document Type : Original Research Article

Authors

1 Department of Obstetrics and Gynecology, school of medicine, Mashhad University of Medical Sciences, Mashhad, Iran

2 Department of Obstetrics and Gynecology, school of medicine, Mashad University of Medical Sciences, Mashhad, Iran

3 Clinical Research Unit, Mashhad University of Medical Sciences, Mashhad, Iran

10.22038/jmrh.2025.68872.2021

Abstract

Background & aim: Administration of antibiotic during expectant management leads to normal vaginal flora disturbance, growth of virulent microorganisms and decreased latency period. The present survey was performed with aim to determine the effect of vaginal probiotic capsules on prolonging latency period from rupture of membranes to delivery in 24-32 weeks of pregnancy.
Methods:  This randomized clinical trial study was implemented in 2017-2019 on 64 pregnant women with a singleton pregnancy and premature preterm rupture of membranes (PPROM) and gestational age (GA) of 24-32 weeks at the time of PROM. The subjects were randomly divided in two groups. Both groups received standard PROM treatment, but in the investigation group, a vaginal probiotic capsule (500 mg) was inserted daily for 10 days. The clinical characteristics and outcomes were recorded. Data were analyzed using student t-test, Mann–Whitney U test, Chi-square, and Fisher exact tests.  P<0.05 was considered statistically significant.
Results: No significant difference was found between the two groups regarding age, BMI, gestational age at the time of rupture of membranes, and latency period from rupture of membranes to delivery. The two groups showed no significant difference regarding smoking, delivery route, neonatal gender, indication for cesarean section, blood culture, cause of NICU admission and infant death at the first week, postpartum hemorrhage, methods of PROM diagnosis and cause of pregnancy termination, but total duration of NICU stay was significantly higher in the control group than in the intervention group.
Conclusion: Vaginal probiotic capsule has no effect in prolonging latency period.

Keywords

Main Subjects