Azithromycin for Incompetent Cervix

This trial tests whether adding azithromycin, an antibiotic, can help prolong pregnancy for women at risk of mid-trimester loss or early preterm birth. Participants will undergo a transvaginal cervical cerclage, which involves placing a stitch in the cervix to help prevent early birth. Some women will receive azithromycin with the procedure, while others will not, to determine if the antibiotic makes a difference. Women pregnant with one baby, between 16 and 24 weeks along, and needing a cerclage could be a good fit for this trial. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used systemic antibiotics in the past 7 days.

Previous studies have found azithromycin to be generally safe for people. Research shows that a single oral dose of azithromycin can reduce the risk of certain complications. When combined with cerclage, a procedure that involves placing a stitch to support the cervix, azithromycin can help extend pregnancy and lower the chance of early birth. Although azithromycin is not always recommended for a short cervix alone, it has shown positive effects when used with procedures like cerclage. Overall, the treatment is well-tolerated, and serious side effects are rare.¹²³⁴⁵

Unlike the standard of care for an incompetent cervix, which typically involves a surgical procedure called a cerclage, the addition of azithromycin offers a novel approach. Azithromycin is an antibiotic that not only targets bacterial infections but also has anti-inflammatory properties. Researchers are excited because these properties could potentially reduce inflammation and infection risks, which are known contributors to preterm birth. This dual-action approach could enhance the effectiveness of the traditional cerclage, potentially improving outcomes for women at high risk of mid-trimester loss or early preterm birth.

This trial will compare the use of azithromycin with a transvaginal cervical cerclage to cerclage without azithromycin. Research has shown that azithromycin combined with a transvaginal cervical cerclage (a surgery to help prevent early birth) might help extend pregnancy. Some studies suggest that adding azithromycin can lower the risk of early delivery and slightly increase baby weights. In cases where the cervix opens too soon, azithromycin with cerclage has been linked to better outcomes for both the pregnancy and the newborn. However, not all studies agree, as some found no strong evidence to regularly use azithromycin for women with a short cervix. Overall, while the data is promising, results can vary.¹²³⁵⁶