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

April 11, 2018 updated by: mohamed abd elhamied abd elgaber, Ain Shams University

ADDATION OF Azithromycin TO CEFAZOLIN PRE ELECTIVE C S

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Elabasy
      • Cairo, Elabasy, Egypt, 23
        • Recruiting
        • Ain shams
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Cefazolin
NO_INTERVENTION: Study Group
This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: mohamed 20 amar, md, Ain shams

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 20, 2018

Primary Completion (ANTICIPATED)

June 20, 2018

Study Completion (ANTICIPATED)

August 20, 2018

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2377

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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