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A Trial of Trimethoprim-Sulfamethoxazole in Pregnancy to Improve Birth Outcomes. BACKGROUND: Maternal infections underlie several adverse birth outcomes. Whether trimethoprim-sulfamethoxazole prophylaxis during pregnancy will improve birth outcomes is unknown. METHODS: In a double-blind, randomized, placebo-controlled trial in Zimbabwe, we assigned pregnant women to receive trimethoprim-sulfamethoxazole, at a dose of 960 mg daily, or placebo from at least 14 weeks' gestation until delivery. The primary outcome was birth weight. RESULTS: Among 993 participants (131 with human immunodeficiency virus infection), 498 were randomly assigned to receive placebo and 495 to receive trimethoprim-sulfamethoxazole, with the first dose received at a median of 21.7 weeks' gestation (interquartile range, 17.3 to 26.4). In intention-to-treat analyses, the mean (±SD) birth weight was 3040±460 g in the trimethoprim-sulfamethoxazole group and 3019±526 g in the placebo group (mean difference, 20 g, 95% confidence interval, -43 to 83; P = 0.53). The number of adverse events was similar in the two groups. CONCLUSIONS: In Zimbabwe, trimethoprim-sulfamethoxazole prophylaxis during pregnancy did not significantly increase infant birth weight. (Funded by Wellcome and others; Pan African Clinical Trials Registry number, PACTR202107707978619.).