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A Trial of Trimethoprim–Sulfamethoxazole in Pregnancy to Improve Birth Outcomes

Article scientifique 2025 Anglais

Résumé

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.).

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Chasekwa, B., Munhanzi, F., Madhuyu, L., Mbewe, G., Mabika, V., Chidhanguro, D., Kofi, T., Munengiwa, J., Mapfumo, H., Musapa, M., Shumba, S., Hungwe, E., Nhokwara, M., Bushe, N., Kufa, R., Mazula, P., Chikombingo, M., Tengende, A., Zanga, A., Ziruma, A., Bere, T., Munyengwa, S., Mudimbu, C., Murwira, Z., Mudzingwa, S., Mpofu, E., Mutasa, B., Sauramba, V., Masakadze, E., Runodamoto, T., Chiorera, C., Mushininga, A., Bourke, C., Robertson, R., Perussolo, ., Donos, N., Nyachowe, C., Muchekeza, M., Chikunya, J., Smuk, M., Mutasa, K., Tavengwa, N., Langhaug, L., Ntozini, R., Munjanja, S., Prendergast, A. (2025). A Trial of Trimethoprim–Sulfamethoxazole in Pregnancy to Improve Birth Outcomes. https://doi.org/10.1056/nejmoa2408114

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