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Antibiotic Prophylaxis for Elective Cesarean Section (TOAPFECSACT)

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ClinicalTrials.gov Identifier: NCT02177994
Recruitment Status : Completed
First Posted : June 30, 2014
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
AMR HELMY YEHIA, Ain Shams Maternity Hospital

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.

Condition or disease Intervention/treatment Phase
Infection of Cesarian Section Wound Following Delivery Drug: ceftriaxone 1gm for intravenous infusion Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: cefaxon




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)


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): NCT02177994


Locations
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Egypt
Antibiotic Prophylaxis for Elective Cesarean Section
Cairo, Egypt, +20
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Amr AH Helmy, MD Ain Shams Maternity Hospital

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Responsible Party: AMR HELMY YEHIA, Lecturer in OB GYN, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02177994     History of Changes
Other Study ID Numbers: TOAPFECSACT
AinShamsMH ( Other Identifier: AinShamsMH )
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by AMR HELMY YEHIA, Ain Shams Maternity Hospital:
Elective Cesarean Section
Antibiotic prophylaxis
Timing of Antibiotic prophylaxis
post cesarean section infection
Additional relevant MeSH terms:
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Infection
Anti-Bacterial Agents
Ceftriaxone
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents