Antibiotic Prophylaxis for Elective Cesarean Section (TOAPFECSACT)

June 24, 2015 updated by: AMR HELMY YEHIA, Ain Shams Maternity Hospital

Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial

A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 3

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, +20
        • Antibiotic Prophylaxis for Elective Cesarean Section

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 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing elective cesarean section with Gestational age 37 weeks or more

Exclusion Criteria:

  1. Fever greater than 38°C or maternal sepsis.
  2. Cephalosporin allergy.
  3. Exposure to any antibiotic agent within 1week before delivery.
  4. Patents having premature rupture of membranes and acute chorioamnionitis.
  5. Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).

3) Morbid obesity (BMI>30)

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A ceftriaxone after cord clamping

165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive

1 gm. ceftriaxone via l intravenous infusion single dose after cord clamping.
Drug: ceftriaxone 1gm for intravenous infusion
Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
Other Names:
  • cefaxon
Active Comparator: Group B ceftriaxone before skin incision

165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive

1 gm. ceftriaxone vial intravenous infusion single dose 30-60 minutes before skin incision.
Drug: ceftriaxone 1gm for intravenous infusion
Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
Other Names:
  • cefaxon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is the rate of post cesarean section surgical site infection.
Time Frame: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
postoperative assessment of SSI. Patients will be followed up at 48-72 hours postoperative, at 7th days (skin suture removal) and at 6 weeks (contraception application).all patients will be contacted by telephone and interviewed. They will be rescheduled for a clinic visit if they reported signs and symptoms of wound infection (purulent discharge or erythema >1 cm in diameter, induration of the incision site and fever).
administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other post cesarean section maternal and neonatal infection
Time Frame: follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery
  1. Maternal complications: other post cesarean section maternal complications, namely endometritis, pyrexia, urinary tract infection and complication of drug administration such as anaphylaxis.
  2. Neonatal complications: such as neonatal sepsis
follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Amr AH Helmy, MD, Ain Shams Maternity Hospital

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

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOAPFECSACT
  • AinShamsMH (Other Identifier: AinShamsMH)

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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