Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections
Not Applicable
Terminated
- Conditions
- InfectionEndometritisCesarean Delivery Affecting FetusWounds InjuriesObstetric Labor Complications
- Registration Number
- NCT04163679
- Lead Sponsor
- Womack Army Medical Center
- Brief Summary
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- Detailed Description
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Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 84
Inclusion Criteria
- full term pregnancy
- undergoing labored, non-emergent cesarean section
- patient in labor
Exclusion Criteria
Azithromycin contraindicated:
- Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
- liver dysfunction
- Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
- A history of a cardiac dysrhythmia (irregular heartbeats)
- Known hypersensitivity to iodine
- Patients carrying fetuses with known congenital anomalies
- Immunodeficiency
- Patients who are not in labor at the time of delivery
- Non-english speaking subjects or subjects with language barriers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Infection rates six weeks postpartum endometritis
- Secondary Outcome Measures
Name Time Method Infant Birth Weight Four weeks after birth record their birth weight (gm)
Infant Apgar scores Four weeks after birth Apgar scores
Infant Length of hospital stay Four weeks after birth Hospital stay (days)
Numbers of Infants admitted to NICU four weeks after birth Infant admission to neonatal intensive care unit
Number of Infants that develop respiratory distress Four weeks after birth The infant acquiring the condition of respiratory distress
Number of Infants that develop sepsis Four weeks after birth Infant acquiring sepsis
Number of infants that die Four weeks after birth Infant death
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of vaginal preparation in reducing post-cesarean endometritis and wound infections?
How does azithromycin compare to standard-of-care antibiotics in preventing post-cesarean infections in high-risk patients?
Which biomarkers are associated with response to vaginal preparation and azithromycin combination therapy in post-cesarean care?
What are the potential adverse events of combining vaginal preparation with azithromycin in postpartum women and how are they managed?
Are there alternative combination therapies to azithromycin and vaginal preparation for preventing post-cesarean infections in obstetric populations?
Trial Locations
- Locations (1)
Womack Army Medical Center
🇺🇸Fort Bragg, North Carolina, United States
Womack Army Medical Center🇺🇸Fort Bragg, North Carolina, United States