Study endpoints
bleeding, vaginal or urinary tract infection, diarrhea, preterm premature rupture of the membranes and/or, constipation
SECONDARY, PRETERM LABOR, BLEEDING
The primary endpoint was restoration of the normal vaginal microbiota (Nugent score 0–3). The secondary endpoints were the incidence of PTD (defined as spontaneous birth at or before 36 + 6 gestational weeks) due to preterm premature rupture of the membranes and/or preterm labor, gestational age at delivery (recorded as term birth if delivered at or after 37 + 0 gestational weeks), neonatal birthweight, live birth rate (defined as birth of an infant with an Apgar score at 1 min of > 0), and the delivery mode (i.e., spontaneous vaginal birth, cesarean section, or instrumental vaginal delivery). As we exclusively enrolled asymptomatic pregnant women, the exclusion criteria for this study were clinical signs of a vaginal or urinary tract infection, bleeding, diarrhea, constipation, and antibiotic therapy within 4 weeks before study enrollment. Patient records and data were separated and investigator-blinded, password-protected, and de-identified prior to the analysis.