Antibiotic Prophylaxis for Elective Cesarean Section

Overview

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.

Full Title of Study: “Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

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)

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • 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

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams Maternity Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: AMR HELMY YEHIA, Lecturer in OB GYN – Ain Shams Maternity Hospital
  • Overall Official(s)
    • Amr AH Helmy, MD, Principal Investigator, Ain Shams Maternity Hospital

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