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Completed

NCT Number: NCT02177994

Antibiotic Prophylaxis for Elective Cesarean Section

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.

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Key information

Conditions

Infection of Cesarian Section Wound Following Delivery

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Antibiotic Prophylaxis for Elective Cesarean Section

Cairo, +20, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • Morbid obesity (BMI>30)

Treatment and study plan

ceftriaxone 1gm for intravenous infusion

Drug

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

Primary outcomes

  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 outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Acronym: TOAPFECSACT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2014
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.