| NCT ID | NCT06543290 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Arrowhead Regional Medical Center |
| Condition | Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-08-07 |
| Primary Completion | 2026-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 400 participants in total. It began in 2023-08-07 with a primary completion date of 2026-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06543290 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06543290 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06543290 currently recruiting?
Yes, NCT06543290 is actively recruiting participants. Contact the research team at knalbandian@westernu.edu for enrollment information.
Where is the NCT06543290 trial being conducted?
This trial is being conducted at Colton, United States.
Who is sponsoring the NCT06543290 clinical trial?
NCT06543290 is sponsored by Arrowhead Regional Medical Center. The trial plans to enroll 400 participants.