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/30089070/Actively Recruiting
Led by Arrowhead Regional Medical Center · Updated on 2025-09-12
400
Participants Needed
1
Research Sites
N/A
Total Duration
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
Azithromycin Before Induction
K
Kristina Nalbandyan, DO
K
Kristina Roloff, DO
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Arrowhead Regional Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Azithromycin (2 grams before induction) | Placebo (4 magnesium oxide tablets before induction) |
|---|---|---|
| What it is | Oral azithromycin (2 grams) given as a single dose prior to labor induction in pregnant women. | Matching placebo (4 magnesium oxide tablets) given as a single dose before labor induction. |
| Role in the study | Investigational arm to assess whether azithromycin reduces the risk of infections during and after labor induction. | Comparator arm to measure rates of infection without added antibiotic prophylaxis. |
| Primary use | Intended for infection prevention around induction of labor in pregnant women. | Used as a matched control for evaluating standard infection risk without additional antibiotic prophylaxis. |
| How it is given or performed | Given as a single 2 gram oral dose prior to starting the induction process. | Administered as 4 oral placebo (magnesium oxide) tablets prior to the beginning of induction. |
| Evidence status | Clinical evidence for azithromycin reducing infection risk exists for cesarean delivery, but its benefit for vaginal delivery during induction remains under investigation. This trial will add to the evidence base. | Represents standard care, where most women undergoing induction do not receive azithromycin prophylaxis. Maternal peripartum infection rates in this setting are reported in systematic reviews. |
| Important limitations | Potential risks such as antibiotic resistance and side effects are not fully established in the context of routine use before induction. Current evidence mainly covers cesarean delivery, not induction for vaginal birth. | Does not provide active antimicrobial coverage. Infection risk may be higher in certain groups where prophylaxis is not used. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor