BOHEMIA results strengthen evidence on the safety of ivermectin in early pregnancy
- Nercio Machele
- 2 days ago
- 3 min read
A study conducted as part of the BOHEMIA (Broad One Health Endectocide-based Malaria Intervention in Africa) project has provided new data on the safety of ivermectin during the early weeks of pregnancy.
The results indicate that women exposed to ivermectin around the time of conception did not have a significantly increased risk of miscarriage, stillbirth or major congenital anomalies compared with women who received albendazole. Funded by Unitaid and implemented in Mozambique by the Centro de Investigação em Saúde de Manhiça (CISM), the BOHEMIA project was led by the Barcelona Institute for Global Health (ISGlobal) in collaboration with CISM and other partner institutions.
The study, published in the scientific journal eClinicalMedicine, constitutes the largest prospective cohort to date of women exposed to ivermectin during the early weeks of pregnancy, contributing to the growing body of scientific evidence on the use of this medicine during this period.
Research conducted in Mozambique and Kenya
The BOHEMIA project was developed to assess the potential of mass administration of ivermectin as a complementary strategy to reduce malaria transmission. In Mozambique, activities were implemented in Mopeia District, Zambézia Province, where the interventions and participant follow-up took place as part of the clinical trial.
To generate new evidence on the safety of the medicine, researchers followed a prospective cohort embedded within the BOHEMIA trials conducted in Mozambique and Kenya. The study included women who became pregnant between two weeks before and four weeks after receiving ivermectin or albendazole, which was used as the comparator medicine. All participants were followed monthly until the end of pregnancy.
According to Patricia Nicolas, researcher at ISGlobal and CISM and first author of the article, 238 women were included, of whom 129 had potentially been exposed to ivermectin and 109 to albendazole. “Among participants with known pregnancy outcomes, adverse outcomes including miscarriage, stillbirth or major congenital anomalies occurred in 22.9% of women exposed to ivermectin and 19.5% of women exposed to albendazole. The difference between the two groups was not statistically significant,” she explained.
Prenatal care associated with better outcomes
The study also found that women who experienced adverse pregnancy outcomes were less likely to have received prenatal care and recommended preventive measures during pregnancy. These measures included iron and folic acid supplementation, the use of insecticide-treated bed nets and malaria preventive treatment. “However, we caution that women who experience very early pregnancy losses may have fewer opportunities to attend antenatal care visits,” added Patricia Nicolas.
For CISM Director-General Francisco Saúte, the findings demonstrate the importance of scientific research conducted in African settings to address priority public health questions. “Although the results do not show a significant increase in the risk of adverse pregnancy outcomes associated with ivermectin exposure in early pregnancy, it is essential to continue generating knowledge through robust studies that can inform future recommendations based on scientific evidence,” he said.
Meanwhile, Carlos Chaccour, BOHEMIA co-principal investigator, considers that the findings strengthen the available evidence on the safety of ivermectin during the first weeks of pregnancy. “However, the number of documented cases remains limited to support changes to clinical or regulatory recommendations. Further studies and surveillance systems are needed to consolidate these findings,” he stressed.
A One Health approach
The BOHEMIA project is based on the One Health approach, recognising the interconnection between human, animal and environmental health. The research was based on the premise that mosquitoes are changing their behaviour patterns — avoiding contact with insecticide-treated bed nets and walls, preferring to bite outdoors, shifting their peak activity times and feeding on animal blood.
This news article was prepared based on the original publication by ISGlobal on the findings of the study conducted as part of the BOHEMIA project.References
Nicolas P, Mundaca H, Brazeal A, Houana A, Ngama M, Macucha A, Matano A, Elobolobo E, Vegove V, Martinho S, Kariuki M, Mbanze J, Mitora S, Montañà J, Ringera I, Túnez L, Imputiua S, Munguambe H, Mutepa V, Soares A, Xerinda A, Materrula F, Ruiz-Castillo P, Onyango T, Casellas A, Rudd M, Jones C, Maia M, Mwangangi J, Rabinovich R, Saute F, Chaccour C. Risk of adverse pregnancy outcomes following inadvertent exposure to ivermectin during the periconception period: findings from two cluster-randomized trials in Mozambique and Kenya. EClinicalMedicine. 2026 Jul 14;97:104069. doi: 10.1016/j.eclinm.2026.104069. PMID: 42518939; PMCID: PMC13382460.
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