Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.
William A Grobman, Madeline M Rice, Uma M Reddy...
https://pubmed.ncbi.nlm.nih.gov/30089070Actively Recruiting
Phase 1
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06543290
Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
Led by Arrowhead Regional Medical Center · Updated on 2025-09-12
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether taking 2 grams of oral azithromycin before labor induction in pregnant women during their third trimester can reduce maternal and newborn infections. The trial focuses on women undergoing induction of labor, a common procedure that has increased recently. Researchers want to see if this antibiotic can help prevent infections like chorioamnionitis, endometritis, and wound infections, improving health outcomes and potentially reducing hospital stays and costs. Participants will be randomly assigned to one of two groups: one will receive 2 grams of azithromycin (four 500 mg tablets) once before labor induction, and the other will receive a placebo of four magnesium oxide tablets once before induction. This is a double-blinded study, meaning neither participants nor researchers know who receives the antibiotic or placebo during the trial. Women in the study will be monitored from the time of labor induction through delivery and for six weeks postpartum. Researchers will assess infection rates using a composite infection measure and track any infections that occur during this period. Safety and health outcomes for both mothers and newborns will be carefully followed to understand the impact of azithromycin given before labor induction.
CONDITIONS
Brief Title
Azithromycin Before Induction
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant women in third trimester (28 0/7 weeks or more)
- Singleton pregnancy
- Age between 18 and 45 years
- Scheduled for induction of labor for medical, obstetrical, or elective reason over 39 weeks
- No contraindication to vaginal delivery
- Reassuring fetal heart rate tracing
- Able and willing to provide informed consent
You will not qualify if you...
- Unable to read or write in English or Spanish
- Unable or unwilling to give informed consent
- Use of antibiotics or antiviral agents within the last 7 days
- Active infection at time of induction (except rectovaginal group B streptococcus colonization without active infection)
- Incarcerated women
- Active substance abuse
- Age under 18 years
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Induction period (varies by participant)
Participants receive a single dose of either 2 grams oral azithromycin or placebo prior to the start of induction of labor.
1 visit (in-person) prior to induction
Follow-up
Duration - Up to 6 weeks postpartum
Participants are monitored for infection and other outcomes through delivery and up to 6 weeks postpartum.
Approximately 2 visits (delivery and postpartum)
Trial Site Locations
Total: 1 location
1
Arrowhead Regional Medical Center
Colton, California, United States, 92324
Actively Recruiting
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Research Team
K
Kristina Nalbandyan, DO
K
Kristina Roloff, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Elective induction of labor at 39 weeks compared with expectant management: a meta-analysis of cohort studies.
William A Grobman, Aaron B Caughey
https://pubmed.ncbi.nlm.nih.gov/30817905Incidence of maternal peripartum infection: A systematic review and meta-analysis.
Susannah L Woodd, Ana Montoya, Maria Barreix...
https://pubmed.ncbi.nlm.nih.gov/31821329Diagnosis and management of clinical chorioamnionitis.
Alan T N Tita, William W Andrews
https://pubmed.ncbi.nlm.nih.gov/20569811Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial.
Stephanie L Pierce, Jennifer D Peck, Christy Zornes...
https://pubmed.ncbi.nlm.nih.gov/35728781Adjunctive Azithromycin Prophylaxis for Cesarean Delivery.
Alan T N Tita, Jeff M Szychowski, Kim Boggess...
https://pubmed.ncbi.nlm.nih.gov/27682034