Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

August 18, 2019 updated by: Ghada fayed hashem el sharkawy, Ain Shams University

Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women

efficacy of adding azithromycin to cephalosporin before cesarean delivery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams Maternity Hospital

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

17 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age between 17 and 39 years
  • gestaional age between 37 to 42 weeks
  • elective cesarean delivery
  • obese women

Exclusion Criteria:

  • diabetic women on corticosteroids
  • intraopertaive complication in previous section
  • history of septic woun
  • prelabour rupture of membrane >12 hours

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cephalosporin arm
72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision
Drug: cephalosporin
72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
Active Comparator: cephalosporin +azithromycin arm
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
Drug: cephalosporin
72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
Drug: Azithromycin Tablets
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of women with wound infection
Time Frame: after 14 days post cesarean delivery
superficial and deep surgical site wound infection will be looked for by laboratory confirmation
after 14 days post cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of women with postpartum endometritis
Time Frame: after 14 days post cesarean delivery
fever, abdominal pain , uterine tenderness will be looked for
after 14 days post cesarean delivery

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Reda Mokhtar, MD, AinShams university ,egypt el abbasia

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 (Actual)

March 20, 2019

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

July 18, 2019

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 18, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 18, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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