Efficacy of Vaginal Probiotic Therapy in Modulating Fetomaternal Outcomes in Preterm Premature Rupture of Membranes

Abstract

Objectives: To evaluate the efficacy of adjunctive vaginal probiotics added to standard therapy in improving the fetomaternal outcomes among women presenting with preterm premature rupture of membranes (PPROM).

Study Design: Randomized controlled trial.

Place and Duration of Study: MCH, PIMS, Islamabad, from January 2024 to June 2024.

Methodology: A total of 100 women aged 18–40 years presenting with PPROM between 28+0 and 33+6 weeks of gestation were randomized into two equal groups. All women received standard PPROM management, while the intervention group additionally received a Lactobacillus vaginal capsule (containing ≥1 × 10⁹ CFU) nightly for 10 days. The primary outcome was NICU admission, while the secondary maternal and neonatal outcomes included latency period, delivery within 7 days, chorioamnionitis, Nugent score, bacterial vaginosis, vaginal pH, inflammatory markers, birth weight, Apgar score, respiratory distress syndrome (RDS), early-onset sepsis, and neonatal mortality.

Results: NICU admission (the primary outcome) was significantly lower in the intervention group than in the control group (14% vs 40%, p<0.01). The intervention group had a longer latency period (p<0.001), lower delivery within 7 days (p<0.001), decreased bacterial vaginosis (p=0.03) and less chorioamnionitis (p<0.001).  Nugent score (p<0.001) and WBC count (p=0.03) also improved significantly. Birth weight and 5-minute Apgar score were also higher in the probiotic group (p<0.001, for both). No significant differences were observed in RDS, early-onset sepsis, or neonatal mortality.

Conclusion: Vaginal probiotic therapy adjunctive to standard therapy was associated with improved fetomaternal outcomes including reduced NICU admission, prolonged latency, reduced chorioamnionitis and improved birth weight in women with PPROM.