A Trial of Trimethoprim–Sulfamethoxazole in Pregnancy to Improve Birth Outcomes
Abstract
In this double-blind, randomized, placebo-controlled trial conducted in Zimbabwe, 993 pregnant women (including 131 with HIV infection) were assigned to receive either daily trimethoprim–sulfamethoxazole (960 mg) or placebo from ≥14 weeks’ gestation until delivery. The primary outcome was infant birth weight.
At delivery, the mean birth weight was 3040±460 g in the trimethoprim–sulfamethoxazole group and 3019±526 g in the placebo group (mean difference: 20 g; 95% CI, −43 to 83; P=0.53). No significant differences were observed in secondary outcomes, including low birth weight (10.0% vs. 11.6%), preterm birth (6.9% vs. 11.5%), or small-for-gestational-age status (20.3% vs. 17.7%). Adverse events were similar between groups.