Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.
NCT ID: NCT03502356
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
400 participants
INTERVENTIONAL
2018-04-20
2018-08-20
Brief Summary
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Detailed Description
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Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups. Both two group will receive standard prophylaxis antibiotic CEFAZOLIN (zinol) (at a dose of 1 g) 2 hours preoperative.
Control Group:
This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
Study Group:
This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)
Inclusion criteria:
* Gestational age of 37 0/7 weeks and greater
* Elective cesarean section
* Medicaly free pregnant women
Exclusion criteria:
* a known allergy to azithromycin
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes
Conditions
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Study Design
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RANDOMIZED
PARALLEL
This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
Study Group:
This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)
PREVENTION
SINGLE
Study Groups
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Control Group
This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
Azithromycin
In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
Study Group
This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)
No interventions assigned to this group
Interventions
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Azithromycin
In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective cesarean section
* Medicaly free pregnant women
Exclusion Criteria
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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mohamed abd elhamied abd elgaber
cario egypt
Principal Investigators
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mohamed 20 amar, md
Role: STUDY_CHAIR
ain shams
Locations
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Ain Shams
Cairo, Elabasy, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2377
Identifier Type: -
Identifier Source: org_study_id
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