Secondary and Exploratory Outcomes
PRETERM BIRTH, ENDOMETRITIS, RECURRENCE, VAGINAL BLEEDING, NEONATAL INFECTION, INTRAUTERINE GROWTH RESTRICTION, SPONTANEOUS ABORTION, SECONDARY, FETAL DEATH, MISCARRIAGE, PREMATURE RUPTURE OF MEMBRANES, PREECLAMPSIA
Prespecified secondary clinical outcomes were rates of preterm birth before 26, 28, and 32 weeks’ gestation, premature rupture of membranes, intrauterine growth restriction, endometritis, and total hospital length of stay. Other exploratory outcomes measured in the intervention group were rate of BV, treatment recurrence rate (defined as a positive control vaginal swab using qPCR after a previous control vaginal swab was negative), spontaneous abortion (before 22 weeks’ gestation), late miscarriage (between 22 and 24 weeks’ gestation), fetal death, preeclampsia, vaginal bleeding, neonatal infection, transfers, length of stay, and neonatal mortality.