Antibiotic Prophylaxis for Elective Cesarean Section

Phase 3

Completed

• Conditions: Infection of Cesarian Section Wound Following Delivery
• Interventions: Drug: ceftriaxone 1gm for intravenous infusion

• Registration Number: NCT02177994
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Primary Completion: 2014-08
• Study Completion: 2014-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 328

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A ceftriaxone after cord clamping	ceftriaxone 1gm for intravenous infusion	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.
Group B ceftriaxone before skin incision	ceftriaxone 1gm for intravenous infusion	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the rate of post cesarean section surgical site infection.	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

Name	Time	Method
other post cesarean section maternal and neonatal infection	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

Trial Locations

Locations (1)

Antibiotic Prophylaxis for Elective Cesarean Section; 🇪🇬 Cairo, Egypt