search
Back to results

Antibiotic Prophylaxis for Elective Cesarean Section (TOAPFECSACT)

Primary Purpose

Infection of Cesarian Section Wound Following Delivery

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
ceftriaxone 1gm for intravenous infusion
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection of Cesarian Section Wound Following Delivery focused on measuring Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Antibiotic Prophylaxis for Elective Cesarean Section

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A ceftriaxone after cord clamping

Group B ceftriaxone before skin incision

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary outcome is the rate of post cesarean section surgical site infection.
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).

Secondary Outcome Measures

other post cesarean section maternal and neonatal infection
Maternal complications: other post cesarean section maternal complications, namely endometritis, pyrexia, urinary tract infection and complication of drug administration such as anaphylaxis. Neonatal complications: such as neonatal sepsis

Full Information

First Posted
June 27, 2014
Last Updated
June 24, 2015
Sponsor
Ain Shams Maternity Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02177994
Brief Title
Antibiotic Prophylaxis for Elective Cesarean Section
Acronym
TOAPFECSACT
Official Title
Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection of Cesarian Section Wound Following Delivery
Keywords
Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A ceftriaxone after cord clamping
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B ceftriaxone before skin incision
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ceftriaxone 1gm for intravenous infusion
Other Intervention Name(s)
cefaxon
Intervention Description
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)
Primary Outcome Measure Information:
Title
The primary outcome is the rate of post cesarean section surgical site infection.
Description
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).
Time Frame
administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
Secondary Outcome Measure Information:
Title
other post cesarean section maternal and neonatal infection
Description
Maternal complications: other post cesarean section maternal complications, namely endometritis, pyrexia, urinary tract infection and complication of drug administration such as anaphylaxis. Neonatal complications: such as neonatal sepsis
Time Frame
follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective cesarean section with Gestational age 37 weeks or more Exclusion Criteria: Fever greater than 38°C or maternal sepsis. Cephalosporin allergy. Exposure to any antibiotic agent within 1week before delivery. Patents having premature rupture of membranes and acute chorioamnionitis. Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease). 3) Morbid obesity (BMI>30)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr AH Helmy, MD
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antibiotic Prophylaxis for Elective Cesarean Section
City
Cairo
ZIP/Postal Code
+20
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Antibiotic Prophylaxis for Elective Cesarean Section

We'll reach out to this number within 24 hrs