SBERRY Trial

This dataset contains the analyzed data from a single-center, double-blind, randomized, placebo-controlled superiority trial (SBERRY trial). The research hypothesis was that daily supplementation with a blend of cranberry extract (100mg), hibiscus extract (20mg), vitamin C (500mg), and Lactobacillus (200 million CFU) would significantly prolong the latency period (time from membrane rupture to delivery) in patients with preterm premature rupture of membranes (PPROM) between 24-34 weeks gestation, compared to an identical placebo.
Data Collection: Data was gathered from 84 pregnant patients diagnosed with PPROM and admitted to the high-risk pregnancy ward of Hospital Escuela, Tegucigalpa, Honduras, between January and July 2025. Participants were randomly assigned (1:1) to receive either the active intervention or placebo capsule once daily until delivery or a maximum of 10 days. Data was collected prospectively via patient interviews and medical record extraction using a standardized case report form. Key variables include group allocation, maternal demographics, obstetric history, gestational age at rupture and delivery, latency period (primary outcome), treatment duration, delivery mode, and maternal/neonatal outcomes (e.g., chorioamnionitis, birth weight, APGAR scores).
Notable Findings: The analysis shows a statistically significant (p=0.003) increase in the mean latency period for the intervention group (11.7 ± 7.2 days) versus the placebo group (7.6 ± 4.8 days), with a mean difference of 4.1 days (95% CI: 1.4–6.8). Exploratory subgroup analysis suggests the effect was most pronounced when treatment was initiated before 32 weeks of gestation and continued for more than 6 days. No statistically significant differences were found in the rates of maternal or neonatal complications between groups.
Interpretation: The data supports the primary hypothesis, indicating the supplement blend may be effective in prolonging pregnancy after PPROM. This could allow for increased fetal maturation and reduce prematurity-related complications. The data is provided in SPSS format (.sav) and can be used to verify the reported analyses, conduct further exploratory analyses, or for educational purposes. Key variables to analyze include ‘Group’ (intervention/placebo), ‘Latency_days’ (continuous), and ‘GA_rupture’ (gestational age at rupture). Analyses should respect the intention-to-treat principle.

(time from membrane rupture to delivery) in patients with preterm