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Macrolide Antibiotic

Azithromycin for Reducing Infections During Labor

Phase 1
Recruiting
Research Sponsored by Arrowhead Regional Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Third trimester of pregnancy defined as 28 0/7 weeks or more
Age 18-45
Must not have
Incarcerated Women
Age < 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery and 6 weeks postpartum
Awards & highlights

Summary

This trial is testing whether giving a certain antibiotic to pregnant women in their third trimester during labor induction can help reduce infections in both the mother and the baby.

Who is the study for?
This trial is for pregnant women in their third trimester (28 weeks or more) who are undergoing labor induction. Participants should be aged 18-45, have a single pregnancy with no complications that would prevent vaginal delivery, and can give informed consent. Women with recent antibiotic use, active infections, substance abuse issues, or inability to understand English or Spanish are excluded.
What is being tested?
The study tests if taking a one-time dose of 2 grams of Azithromycin before inducing labor can reduce maternal and neonatal infections. It's a double-blind trial meaning neither the participants nor the researchers know who gets the real medicine versus a placebo.
What are the potential side effects?
Azithromycin may cause side effects like nausea, vomiting, diarrhea, stomach pain and could potentially lead to allergic reactions. The risk of yeast infections might also increase due to disturbance in natural bacterial balance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in my third trimester of pregnancy, beyond 28 weeks.
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently incarcerated.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery and 6 weeks postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery and 6 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in Composite Infection
Secondary study objectives
Reduction in Infection

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Azithromycin ArmActive Control1 Intervention
Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once.
Group II: Placebo ArmPlacebo Group1 Intervention
Administration of 4 magnesium oxide tablets prior to the start of induction , once.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Arrowhead Regional Medical CenterLead Sponsor
16 Previous Clinical Trials
27,315 Total Patients Enrolled
2 Trials studying Infections
694 Patients Enrolled for Infections
~167 spots leftby Aug 2025
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