Randomized trial of presumptive sexually transmitted disease therapy during pregnancy in Rakai, Uganda

OBJECTIVE: The purpose of this study was to assess presumptive sexually transmitted disease treatment on pregnancy outcome and HIV transmission. STUDY DESIGN: In a randomized trial in Rakai District, Uganda, 2070 pregnant women received presumptive sexually transmitted disease treatment 1 time during pregnancy at varying gestations, and 1963 control mothers received iron/folate and referral for syphilis. Maternal-infant sexually transmitted disease/HIV and infant outcomes were assessed. Intent-to-treat analyses estimated adjusted rate ratios and 95% confidence intervals. RESULTS: Sexually transmitted diseases were reduced: Trichomonas vaginalis (rate ratio, 0.28; 95% Cl, 0.18%-0.49%), bacterial vaginosis (rate ratio, 0.78; 95% Cl, 0.69-0.87), Neisseria gonorrhoeae/Chlamydia trachomatis (rate ratio, 0.43; 95% Cl, 0.27-0.68), and infant ophthalmia (rate ratio, 0.37; 95% Cl, 0.20-0.70). There were reduced rates of neonatal death (rate ratio, 0.83; 95% Cl, 0.71-0.97), low birth weight (rate ratio, 0.68; 95% Cl, 0.53-0.86), and preterm delivery (rate ratio, 0.77; 95% Cl, 0.56-1.05); but there were no effects on maternal HIV acquisition or perinatal HIV transmission. CONCLUSION: Reductions of maternal sexually transmitted disease improved pregnancy outcome but not maternal HIV acquisition or perinatal HIV transmission.