Azithromycin administration does not significantly reduce maternal or neonatal mortality: Study

In recent years, the use of azithromycin as a prophylactic treatment during pregnancy has garnered attention due to its potential benefits for both maternal and neonatal health. Initial randomized controlled trials (RCTs) suggested that azithromycin could improve outcomes which could lead to hopeful anticipation within the medical community. However, this new study published in the eClinicalMedicine journal on azithromycin highlighted the findings which indicated no significant benefit to neonatal survival.

A comprehensive systematic review and meta-analysis meticulously searched seven major databases like PubMed, Scopus, Embase, Cochrane Library, EBSCOHost, ProQuest, and Web of Science, along with clinical trial registries up to April 23, 2024. The focus was on RCTs which compared azithromycin prophylaxis administered either antenatally or intrapartum against placebo or routine care in pregnant women. The primary outcome of interest was neonatal mortality.

The review included data from 20 RCTs that encompassed a total of 56,381 participants. The findings revealed that for intrapartum administration, azithromycin appeared to have little or no effect on neonatal mortality, with a Risk Ratio (RR) of 1.02 (95% CI 0.86–1.20), based on data from five RCTs involving 44,436 participants. Also, the impact on maternal mortality was negligible, with an RR of 1.26 (95% CI 0.65–2.42) from three RCTs including 44,131 participants. The certainty of these findings was rated as very low for neonatal mortality and low for maternal mortality.

The antenatal administration of azithromycin showed comparable results. Three RCTs involving 5,304 participants revealed an RR of 0.74 (95% CI 0.35–1.56) for neonatal mortality which indicated no substantial benefit. For maternal mortality, the RR was 1.62 (95% CI 0.67–3.91) from three RCTs including 8,167 participants. Also, the certainty of this evidence was considered very low for neonatal mortality and low for maternal mortality.

The study also highlighted a significant gap in data regarding long-term adverse outcomes and antimicrobial resistance, areas that require further investigation. These findings challenge the previously held optimism about azithromycin prophylaxis in pregnancy. The low to very low certainty evidence from this meta-analysis suggests that administering azithromycin, whether antenatally or intrapartum, does not significantly reduce maternal or neonatal mortality.

Source:

Shamim, M. A., Kumar, J., Patil, A. N., Tiwari, K., Sharma, S., Anil, A., Saravanan, A., Sandeep, M., Varthya, S. B., Singh, S., Ahmed, M. I., Najmi, A., Shamim, M. A., Gandhi, A., Satapathy, P., Sah, R., Rustagi, S., Gaidhane, A. M., Zahiruddin, Q. S., … Dwivedi, P. (2024). PeRinatal, neOnatal, and Maternal OuTcomEs with azithromycin prophylaxis in pregnancy and labour (PROMOTE-PROPHYLAXIS): systematic review and meta-analysis. In eClinicalMedicine (Vol. 73, p. 102691). Elsevier BV. https://doi.org/10.1016/j.eclinm.2024.102691