Azithromycin to improve latency in examination-indicated cerclage: a multicenter randomized controlled trial

Area of Science:

• Obstetrics and Gynecology
• Maternal-Fetal Medicine
• Pharmacology

Background:

• Physical exam-indicated cerclage is used to prolong pregnancy in cases of early cervical dilation.
• Previous studies suggest azithromycin may prolong latency in cervical shortening, but evidence is limited for cerclage procedures.
• A prior RCT indicated perioperative cefazolin and indomethacin improved pregnancy duration with cerclage.

Purpose of the Study:

• To evaluate if adding azithromycin to cefazolin and indomethacin enhances pregnancy latency in physical exam-indicated cerclage.
• To compare pregnancy prolongation between standard cerclage care and standard care plus azithromycin.

Main Methods:

• An open-label, multicenter randomized clinical trial (RCT) involving singleton gestations undergoing physical exam-indicated cerclage.
• Participants were randomized to receive standard care (cefazolin and indomethacin) or standard care plus azithromycin.
• The primary outcome was gestational latency from cerclage placement to delivery; secondary outcomes included preterm birth and neonatal complications.

Main Results:

• Fifty-four participants were randomized (27 per group).
• The median gestational latency did not significantly differ between the azithromycin and control groups (92 vs. 85 days, p=0.93).
• No statistically significant differences were observed in secondary obstetric or neonatal outcomes.

Conclusions:

• Perioperative azithromycin, when added to cefazolin and indomethacin, does not improve pregnancy latency in physical exam-indicated cerclage.
• The addition of azithromycin did not yield benefits for other perinatal outcomes in this patient population.