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Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

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ClinicalTrials.gov Identifier: NCT03502356
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
mohamed abd elhamied abd elgaber, Ain Shams University

Brief Summary:
The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.

Condition or disease Intervention/treatment Phase
Randomized Controll Trial Drug: Azithromycin Phase 1 Phase 2

Detailed Description:

Patiants and methods

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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)

Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S
Estimated Study Start Date : April 20, 2018
Estimated Primary Completion Date : June 20, 2018
Estimated Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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 Name: Cefazolin

No Intervention: Study Group
This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)



Primary Outcome Measures :
  1. endometritis [ Time Frame: 6 weeks after surgery ]
    Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502356


Contacts
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Contact: mohamed 20 amar, md 01024706467 ext 02 drmohamed145@gmil.com

Locations
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Egypt
Ain Shams Recruiting
Cairo, Elabasy, Egypt, 23
Contact: mohamed 20 amar, md    01024706467 ext 02    drmohamed145@gmil.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: mohamed 20 amar, md ain shams

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Responsible Party: mohamed abd elhamied abd elgaber, cario egypt, Ain Shams University
ClinicalTrials.gov Identifier: NCT03502356     History of Changes
Other Study ID Numbers: 2377
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Cefazolin
Anti-Infective Agents