Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery
1 other identifier
interventional
144
1 country
1
Brief Summary
efficacy of adding azithromycin to cephalosporin before cesarean delivery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2019
CompletedFirst Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedAugust 20, 2019
August 1, 2019
3 months
August 13, 2019
August 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
% of women with wound infection
superficial and deep surgical site wound infection will be looked for by laboratory confirmation
after 14 days post cesarean delivery
Secondary Outcomes (1)
% of women with postpartum endometritis
after 14 days post cesarean delivery
Study Arms (2)
cephalosporin arm
ACTIVE COMPARATOR72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision
cephalosporin +azithromycin arm
ACTIVE COMPARATOR72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
Interventions
72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
Eligibility Criteria
You may qualify if:
- age between 17 and 39 years
- gestaional age between 37 to 42 weeks
- elective cesarean delivery
- obese women
You may not qualify if:
- diabetic women on corticosteroids
- intraopertaive complication in previous section
- history of septic woun
- prelabour rupture of membrane \>12 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams maternity hospital
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reda Mokhtar, MD
AinShams university ,egypt el abbasia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 13, 2019
First Posted
August 20, 2019
Study Start
March 20, 2019
Primary Completion
June 20, 2019
Study Completion
July 18, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share