A study of almost 1000 pregnant women in Zimbabwe found that a daily dose of a commonly used, safe and inexpensive antibiotic may have led to fewer babies being born early. Among women living with HIV, those who received the antibiotic had larger babies who were less likely to be preterm.
One in four live-born infants worldwide is preterm (born at 37 weeks’ gestation or before), is small for gestational age, or has a low birth weight. The mortality rate for these small and vulnerable newborns is high, with prematurity now the leading cause of death among children younger than 5 years of age. Maternal infections and inflammation during pregnancy are linked to adverse birth outcomes, particularly for babies born to mothers living with HIV, who have a greater risk of being born too small or too soon.
An international group of researchers, led by Professor Andrew Prendergast from Queen Mary University of London, and Bernard Chasekwa from the Zvitambo Institute for Maternal and Child Health Research in Zimbabwe, conducted the Cotrimoxazole for Mothers to Improve Birthweight in Infants (COMBI) randomised controlled trial, to examine whether prescribing pregnant women a daily dose of trimethoprim–sulfamethoxazole (a broad-spectrum antimicrobial agent with anti-inflammatory properties that is widely used in sub-Saharan Africa) would result in heavier birth weights, decreased premature births, and better health outcomes for their babies.
993 pregnant women were recruited from three antenatal clinics in Shurugwi, a district in central Zimbabwe, and received either 960 mg of the drug or a placebo daily. The participants received regular antenatal care during their pregnancies and data regarding their birth outcomes were recorded.
Although birthweight did not differ significantly between the two groups, the trimethoprim–sulfamethoxazole group showed a 40% reduction in the proportion of preterm births, compared to the placebo group. Overall, 6.9% of mothers receiving the drug had babies born preterm, compared to 11.5% of mothers receiving the placebo, and no women receiving antibiotics had babies born prior to 28 weeks. For babies born to a small group of 131 women with HIV, the reduction in premature births was especially marked, with only 2% of births in the trimethoprim–sulfamethoxazole group preterm, as compared with 14% in the placebo group. Babies exposed to antibiotics during pregnancy also showed a 177 gram increase in their birth weight.
Bernard Chasekwa, first author, said: “Our trial, conducted within routine antenatal care and enrolling women predominantly from rural areas, showed that trimethoprim-sulfamethoxazole did not improve birthweight, which was our main outcome. However, there was an intriguing suggestion that it may have improved the length of pregnancy and reduced the proportion of preterm births. We now need to repeat this trial in different settings around the world to see whether antibiotics during pregnancy can help reduce the risk of prematurity.”
Professor Andrew Prendergast, Professor of Paediatric Infection and Immunology at Queen Mary, said: “Our findings suggest that a low-cost, daily antibiotic, in a setting where infections like HIV are common, might reduce the risk of preterm births. We desperately need new strategies to prevent preterm births, which are the leading cause of under-5 child mortality. If we can confirm in other trials that trimethoprim-sulfamethoxazole reduces the risk of babies being born too soon, it would be a promising new approach to help newborns survive and thrive.”
Sophie Hawkesworth, Senior Manager of Clinical Discovery Research at Wellcome, said: “If we are to reduce child mortality globally, it is critical to reduce the risk of preterm births, especially in areas with limited access to neonatal intensive care units and resources. This is a promising study and whilst the primary outcome of birthweight was unaffected in the trial, the prospect that this treatment prevents preterm births warrants further study.”
ENDS
NOTES TO EDITORS
Contact
Honey Lucas
Faculty Communications Officer – Medicine and Dentistry
Queen Mary University of London
Email: h.lucas@qmul.ac.uk or press@qmul.ac.uk
Paper details:
Bernard Chasekwa, et al. “A Trial of Trimethoprim–Sulfamethoxazole in Pregnancy to Improve Birth Outcomes.” Published in New England Journal of Medicine.
DOI: 10.1056/NEJMoa2408114
Under strict embargo until WEDNESDAY 4 JUNE AT 5 PM ET (10 PM UK TIME)
A copy of the paper is available upon request.
Conflicts of interest: None declared.
Funded by:
Supported by a grant (108065/Z/15/Z to Dr. Prendergast) from Wellcome, a grant (MR/T039337/1) from the Medical Research Council, United Kingdom, and an award (206225/Z/17/Z to Dr. Bourke) from Wellcome and the Royal Society.
About Queen Mary
At Queen Mary University of London, we believe that a diversity of ideas helps us achieve the previously unthinkable.
Throughout our history, we’ve fostered social justice and improved lives through academic excellence. And we continue to live and breathe this spirit today, not because it’s simply ‘the right thing to do’ but for what it helps us achieve and the intellectual brilliance it delivers.
Our reformer heritage informs our conviction that great ideas can and should come from anywhere. It’s an approach that has brought results across the globe, from the communities of east London to the favelas of Rio de Janeiro.
We continue to embrace diversity of thought and opinion in everything we do, in the belief that when views collide, disciplines interact, and perspectives intersect, truly original thought takes form.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
Journal
New England Journal of Medicine
Method of Research
Observational study
Subject of Research
People
Article Title
A Trial of Trimethoprim–Sulfamethoxazole in Pregnancy to Improve Birth Outcomes.
Article Publication Date
4-Jun-2025
COI Statement
None declared.