OB/Gyn
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Pregnancy
— Some secondary benefits seen in West African trial, however
by
Ingrid Hein, Staff Writer, MedPage Today
March 7, 2023
Giving azithromycin to mothers during labor did not reduce the incidence of neonatal sepsis or mortality, a randomized trial conducted in Gambia and Burkina Faso found.
Of nearly 12,000 live births in the two West African nations, the primary outcome of neonatal sepsis or mortality at 28 days was a similar 2.0% with intrapartum oral azithromycin and 1.9% with placebo (OR 1.06, 95% CI 0.80-1.38, P=0.70), Anna Roca, PhD, of MRC Unit The Gambia at the London School of Hygiene & Tropical Medicine in Fajara, Gambia, and colleagues reported.
Evaluated separately, the rates of neonatal mortality and sepsis were identical in the two study groups, at 0.8% and 1.3%, respectively, according to the findings in JAMA.
Fewer cases of culture-confirmed sepsis were identified among newborns in the azithromycin group (13 vs 24 in the placebo group), though this difference was not significant. Gram-positive Staphylococcus aureus was the most commonly isolated bacterium (two cases in the azithromycin group and six in the placebo group), while gram-negative bacteria made up 59.5% of the confirmed cases.
“It is unclear why the effect of intrapartum azithromycin on S. aureus carriage and noninvasive disease did not translate into a reduction in neonatal sepsis or neonatal mortality,” Roca and co-authors wrote.
“It may be that sepsis and bacteriologically confirmed sepsis are caused by different pathogens, with gram-negative bacteria, viruses, and/or fungus being more prevalent causes of clinical sepsis,” they continued. “An alternative explanation is that a decrease in sepsis caused by some etiologies is balanced by an increase in other etiologies.”
Among secondary outcomes in the newborns, the azithromycin group had a significantly lower incidence of clinical skin infections (0.8% vs 1.7% in the placebo group) and less use of antibiotics (6.2% vs 7.8%, P
A newly published study has revealed that the use of prophylactic oral azithromycin during labor has failed to prevent the onset of neonatal sepsis or death. The findings, which have been presented in the American Journal of Obstetrics & Gynecology, provide insight into the recommendation of oral azithromycin in public hospital labor settings.
The authors of the study conducted a randomized trial to assess the efficacy of oral azithromycin when administered to pregnant women during labor. The sample group consisted of a total of 10000 women at the public hospital setting in the Gambia, where antenatal records highlighting the presence of maternal Group B Streptococcal bacteriuria, chorioamnionitis, and malaria were documented.
The use of oral azithromycin during labor was found to be ineffective in preventing neonatal sepsis or death, as the results demonstrated no statistically significant difference in the primary outcomes of neonatal sepsis, or all-cause neonatal mortality in the treatment group compared to the control group. The results from the trial indicate that the use of oral azithromycin during labor may not be warranted.
The findings of the study support the need for better and more comprehensive data to inform the recommendation of the use of prophylactic oral azithromycin in labor. Additional research that takes into account biomarkers for infection, such as white cell counts and systemic inflammation, as well as more detailed information on other risk factors could lead to a better understanding of the efficacy of this drug.
In conclusion, the current study highlights a concerning finding regarding the use of prophylactic oral azithromycin during labor, and calls for more research and data to inform public hospital labor settings.
