Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azithromycin Injection, Placebo, Standard of Care Preoperative antibiotics.
- Who it may be relevant to
- Registry conditions: Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
Overview
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
Detailed description
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo.
Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.
Interventions
- Drug Azithromycin Injection
500mg azithromycin in 250 mL of normal saline - Drug Placebo
250 mL of normal saline - Drug Standard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Primary outcome measures
- Maternal infection composite [Time frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)]
Secondary outcome measures (11)
- Non-infections wound complications [Time frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)]
- Perinatal composite outcome [Time frame: hospital discharge, 6 weeks of birth, or death (whichever occurs first)]
- Number of neonates with Allergic Reaction [Time frame: birth through hospital discharge, or 7 days from birth, whichever is earliest]
- Number of Neonates with Gastrointestinal Symptoms [Time frame: birth through hospital discharge, or 7 days from birth, whichever is earliest]
- Number of Maternal Deaths [Time frame: From randomization through 6 weeks postpartum (a period of up to 6 weeks)]
- Maternal Resource Composite [Time frame: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)]
- Neonatal Resource Composite [Time frame: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)]
- Maternal Hospital Length of Stay [Time frame: Hospital admission to hospital discharge (up to 42 days)]
- Rate of Neonatal ICU Admission [Time frame: Delivery to hospital discharge (up to 120 days)]
- Number of Participants with Maternal Resistant Infection [Time frame: Randomization through 6 weeks postpartum (a period of up to 6 weeks)]
- Number of Neonates with Neonatal Resistant Infection [Time frame: From birth up to 6 weeks of age]
Eligibility criteria
Inclusion criteria
- ≥ 23 weeks' gestation (ACOG dating criteria)
- Scheduled or prelabor cesarean delivery
- Singleton or twin gestation
Exclusion criteria
- Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- Chorioamnionitis
- Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
- Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
- Fetal demise or known major congenital anomaly
- Azithromycin treatment within 7 days
- Planned use of antimicrobial prophylaxis after delivery for any reason
- Known structural heart disease or active cardiomyopathy (current ejection fraction<40%)
- Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
- Refusal or unable to obtain consent (e.g., language barrier)
- Participating in another intervention study that influences the primary outcome in this study
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 14 centers
- University of Alabama - Birmingham — Birmingham
- Regents of the University of California San Francisco — San Francisco
- Northwestern University — Chicago
- Columbia University — New York
- University of North Carolina - Chapel Hill — Chapel Hill
- Duke University — Durham
- Case Western Reserve University — Cleveland
- Ohio State University — Columbus
- … and 6 more centers
Identifiers
NCT: NCT06605118 · HD036801-PRECEDE · U01HD114634 · U24HD036801