Mode
Text Size
Log in / Sign up

Azithromycin does not reduce overall perinatal infection rate in labor induction patientsTrial shows azithromycin does not reduce infection risk during labor

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that 2g of oral azithromycin provides no additional benefit for reducing perinatal infection in labor induction.

This randomized controlled trial enrolled 472 women with term singleton pregnancies undergoing labor induction to evaluate the impact of azithromycin on infection rates. Participants were randomized to receive either 2g of oral azithromycin or no treatment.

The primary outcome was the overall perinatal infection rate, including intrapartum and puerperal infections. The study found no significant difference between the groups, with an RR of 0.950. The absolute rates were 16.1% in the azithromycin group versus 16.9% in the control group (ARD -0.85%, 95% CI 0.633-1.425, P=0.804). Secondary outcomes for neonatal infectious diseases also showed no significant difference, with rates of 2.5% versus 5.1% (P=0.149).

Safety data indicated a 3.8% total adverse event rate in the azithromycin group, including 3.4% reporting gastrointestinal symptoms and one case of dizziness. A limitation of the study is its single-center design. In a well-resourced setting with intensive antibiotic prophylaxis already in place, the addition of 2g of azithromycin provides no additional benefit in reducing maternal or perinatal infection risks.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap regarding the role of azithromycin in preventing infections during labor induction. While previous coverage noted that azithromycin does not raise macrolide-resistant gene prevalence in preterm infants, this study confirms that azithromycin does not reduce the overall perinatal infection rate in women undergoing labor induction.

When a woman goes into labor, doctors often use antibiotics to protect both the mother and the newborn from infections. Some have suggested adding azithromycin, a common antibiotic, to this routine to provide extra protection. This study looked at whether that extra dose actually makes a difference in a hospital setting.

Researchers followed 472 women undergoing labor induction. They gave one group 2 grams of oral azithromycin and gave the other group no extra treatment. The results showed that the infection rates were almost identical between the two groups. Specifically, the infection rate was 16.1% for those who took the azithromycin and 16.9% for those who did not.

While the drug was generally well tolerated, with only a few cases of stomach issues or dizziness, it did not provide any extra safety for the babies or mothers. Because the hospital already used strong antibiotic protections, the extra dose of azithromycin did not change the outcome. This finding suggests that the standard care is already sufficient for these patients.

What this means for you:
Adding azithromycin during labor induction does not lower the risk of infection for mothers or their babies.

Common questions

Does azithromycin reduce infection risk for babies during labor?

The study of 472 women found no significant difference in neonatal infectious diseases. The rate of infection in babies was 2.5% for those who received azithromycin and 5.1% for those who did not. Because the results were not statistically significant, the extra dose did not provide a clear benefit.

Is it safe to take azithromycin during labor induction?

The drug was generally well tolerated in this study. About 3.4% of women reported gastrointestinal symptoms, and the total adverse event rate was 3.8%, which included one case of dizziness. However, the study found it did not offer extra protection against infections.

Why didn't the azithromycin work to prevent infections?

The study took place in a well-resourced setting where intensive antibiotic prophylaxis was already in place. Because the standard care was already strong, adding an extra 2g of azithromycin did not provide any additional benefit in reducing the risk of infection for mothers or babies.

Study Details

Study typeRct
Sample sizen = 472
EvidenceLevel 2
PublishedNov 2026
View Original Abstract ↓
OBJECTIVES: This study evaluates oral azithromycin's effectiveness in reducing intrapartum and puerperal infection rates in term pregnant women undergoing labor induction to guide antibiotic prophylaxis. METHODS: This single-center randomized controlled trial enrolled 472 women with term singleton pregnancies undergoing labor induction. The participants were randomly allocated to receive either 2 g of oral azithromycin (n = 236) or no treatment (n = 236). The primary outcome was the overall perinatal infection rate (which includes both intrapartum and/or puerperal infections). Secondary outcomes included maternal and neonatal complications, mode of delivery, and safety parameters. Results analysis adopted an intention-to-treat approach. RESULTS: The overall perinatal infection rate did not differ significantly between the azithromycin group (16.1%) and the control group (16.9%) (absolute risk difference [ARD] = -0.85%, relative risk [RR] = 0.950, 95% confidence interval 0.633-1.425; P = 0.804). Similarly, the incidence of neonatal infectious diseases showed no significant difference between the two groups (2.5% vs 5.1%, P = 0.149). Both groups had comparable outcomes in mode of delivery, maternal-neonatal complications (epidural analgesia, postpartum hemorrhage, and pre- and post-delivery antibiotic use), total labor duration, neonatal hypoglycemia, neonatal intensive care unit admission, and neonatal antibiotic administration. Maternal outcomes did not differ significantly between groups, although 3.4% (8/236) of women in the azithromycin group reported gastrointestinal symptoms during labor, with a total adverse event rate of 3.8% (9/236, including one case of dizziness). CONCLUSION: The use of an additional 2 g azithromycin provides no additional benefit in reducing the overall risk of maternal infection and perinatal infection in an already intensive antibiotic prophylactic and well-resourced setting. CLINICAL TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry, registration number ChiCTR2300077629, November 14, 2023 (https://www.chictr.org.cn/showprojEN.html).
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.