Using azithromycin to prevent infections during labor induction
Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
This study is testing if giving a dose of azithromycin to pregnant women who are being induced for labor can help prevent infections for both the mothers and their babies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Arrowhead Regional Medical Center Academic / other |
| Locations | 1 site (Colton, California) |
| Trial ID | NCT06543290 on ClinicalTrials.gov |
What this trial studies
This double-blinded randomized control trial investigates the administration of 2 grams of prophylactic azithromycin to third trimester patients undergoing labor induction. The study aims to determine if this antibiotic can reduce the rates of maternal and neonatal infections associated with the induction process. Given the rising rates of labor induction and the complications that can arise, this research seeks to clarify the role of antibiotic prophylaxis in this context. Participants will be monitored for infection rates following the administration of the medication.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in their third trimester, aged 18-45, who are undergoing induction of labor for medical or obstetrical reasons.
Not a fit: Patients who have active infections at the time of induction or those who have used antibiotics within the last week may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections in mothers and newborns during labor induction.
How similar studies have performed: Previous studies have shown that azithromycin can effectively prevent infections in obstetrical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Third trimester of pregnancy defined as 28 0/7 weeks or more * Singleton pregnancy * Age 18-45 * Induction of labor initiated for medical or obstetrical reason or electively over 39 weeks of gestation * No contraindication to vaginal delivery * Reassuring fetal heart rate tracing * Able and willing to provide informed consent Exclusion Criteria: * • Does not read or write in English or Spanish * Unable or unwilling to give informed consent * Use of antibiotic or antiviral agent within the last 7 days * Evidence of active infection at the time of initiation of induction (patients with rectovaginal group B streptococcus positive results will be allowed to participate as it is a colonizing organism, unless they show evidence of active infection) * Incarcerated Women * Active substance abuse * Age \< 18
Where this trial is running
Colton, California
- Arrowhead Regional Medical Center — Colton, California, United States (Recruiting)
Study contacts
- Study coordinator: Kristina Nalbandyan, DO
- Email: knalbandian@westernu.edu
- Phone: 8187306222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.