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Oral Concurrent Session 5 - Medical & Surgical Complications

Oral Concurrent Sessions

(54) Azithromycin to Reduce Maternal Infections in Planned Vaginal Birth: Secondary Analysis of the A-PLUS Trial

Wednesday, February 14, 2024
11:15 AM – 11:30 AM  
Location: Potomac Ballroom C, Ballroom Level
Objective: The intrapartum azithromycin trial (A-PLUS Trial) showed a reduction in maternal sepsis or death mainly driven by sepsis. To test the hypothesis that a single oral dose of intrapartum 2g azithromycin (AZI) in women in labor planning a vaginal delivery reduces the incidence of any maternal infection

Study Design: This is a secondary analysis of the A-PLUS Trial involving 29,278 women in seven countries who were randomized to a single oral dose of 2g of AZI vs. placebo. The primary outcome was any maternal infection defined as one or more of any of the following infections after randomization: sepsis (by WHO clinical criteria), chorioamnionitis, endometritis, perineal or cesarean wound infection, abdominopelvic abscess, mastitis/breast abscess, pyelonephritis, pneumonia, and other bacterial infections (meningitis, etc). The relative risk (RR) and 95% confidence interval (CI) of each outcome comparing the azithromycin arm to the placebo arm was estimated using a Poisson model adjusted for treatment arm and site. Subgroup analyses were conducted by: high- and low-risk delivery (high-risk if membrane ruptured ≥8 hours and/or in labor ≥18 hours prior to randomization), region (Africa or Asia), prophylactic antibiotic, delivery mode, type of labor, and preterm/term status. Subgroup analyses included a two-way interaction test between intervention arm and subgroup.

Results: Maternal sepsis or death occurred less often in the azithromycin arm (580/14,558, 4.0%) compared to the placebo arm to 824/14,661, 5.6% in the placebo arm (RR=0.71; 95% CI: [0.64, 0.79], Figure 1). The number needed to treat was 62.

Conclusion: In women in labor in low-resource settings planning a vaginal delivery, intrapartum azithromycin was associated with a lower rate of any maternal infection compared to the placebo group and the NNT was 62 or half of the NNT for maternal death and/or sepsis (NNT 125) in the A-PLUS Trial.