A Trial of Trimethoprim-Sulfamethoxazole in Pregnancy to Improve Birth Outcomes.
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Chasekwa Bernard, Munhanzi Fortunate, Madhuyu Lenin, Mbewe Gabriel, Mabika Vincent, Chidhanguro Dzivaidzo, Kofi Tendai, Munengiwa Jonthan, Mapfumo Hilda, Musapa Mercy, Shumba Sipho, Hungwe Elizabeth, Nhokwara Mary, Bushe Nester, Kufa Rudo, Mazula Phatisiwe, Chikombingo Muchaneta, Tengende Alice, Zanga Admire, Ziruma Asaph, Bere Tsitsi, Munyengwa Success, Mudimbu Charity, Murwira Zvikomborero, Mudzingwa Shepherd, Mpofu Eddington, Mutasa Batsirai, Sauramba Virginia, Masakadze Elisha, Runodamoto Thompson, Chiorera Courage, Mushininga Alfred, Bourke Claire D, Robertson Ruairi C, Perussolo Jeniffer, Donos Nikos, Nyachowe Chandiwana, Muchekeza Mary, Chikunya Jefrey, Smuk Melanie, Mutasa Kuda, Tavengwa Naume V, Langhaug Lisa L, Ntozini Robert, Munjanja Stephen P, Prendergast Andrew J
Аннотация
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.).