Abstract
INFECTED AFRICAN POPULATION ROBERT GOLDENBERG, TAHA TAHA, IRVING HOFFMAN, WAFAIE FAWZI, ANTHONY MWATHA, University of Alabama at Birmingham, Obstetrics/Gynecology, Birmingham, Alabama, Johns Hopkins University, Baltimore, Maryland, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Harvard University, Boston, Massachusetts, Fred Hutchinson Cancer Research Center, Statistical Center for HIV/ AIDS Research Prevention, Seattle, Washington OBJECTIVE: The use of antibiotics to prevent PTB has achieved mixed results. Our goal in this study was to determine if antibiotics given prenatally and during labor reduced the incidence of PTB and histologic chorioamnionitis (HCA). STUDY DESIGN: A double blind randomized placebo – controlled trial of antibiotics to reduce PTB and perinatal transmission of HIV was conducted in 4 African sites. Women were given antibiotics at 20-24 weeks (metronidazole 250 mg and erythromycin 250 mg t.i.d. orally for 7 days) and during labor (metronidazole 250 mg and ampicillin 500 mg q 4 hours) or identically appearing placebos. Endpoints available in 2098 HIV-infected and 335 HIVuninfected women included gestational age (GA) determined by both obstetric and pediatric criteria and birthweight (BWT). Preand post-treatment rates of various STIs were determined and placentas were evaluated for HCA. RESULTS: Comparing antibiotic versus placebo treated women, there were no differences in mean GA at delivery (38.7 vs 38.6 wks p=NS), the percent of PTB (25.3 vs 24.6 p=NS), the time between randomization and delivery (17.1 vs 17.1wks p=NS),meanBWT(2965 vs 2974gp=NS), BWT!1500g (1.6 vs 1.7% p=NS), or !2500g (12.4 vs 13.7% p=NS). Four weeks after the 24-week antibiotic/placebo course, BV was reduced from 44.5 to 23.8% in the antibiotic groups vs 43.3 to 37.5% in the placebo group for an OR of 0.50 (0.41-0.60, p!0.0001). Trichomoniasis decreased from 19.0 to 6.0% in the antibiotic group vs 16.3 to 12.3% in the placebo group for an OR of 0.41 (0.031-0.56%, p!0.0001). However, the placentas showed no difference in the rate of HCA (36.3 vs 35.8% p=NS). CONCLUSION: Despite reducing the rate of vaginal infections, the antibiotic regimen used in this study did not reduce the rate of PTB or low birthweight, increase the time to delivery, or increase mean GA or BWT. Failure of this regimen to reduce the rate of HCA likely explains the reason the antibiotics SMFM Abstracts S3
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