Antibiotic Prophylaxis for Elective Cesarean Section (TOAPFECSACT)

Ain Shams Maternity Hospital

Status and phase: Completed; Phase 3

Conditions: Infection of Cesarian Section Wound Following Delivery

Treatments: Drug: ceftriaxone 1gm for intravenous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02177994

AinShamsMH (Other Identifier)

TOAPFECSACT

Details and patient eligibility

About

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 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)

Enrollment: 328 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

Group A ceftriaxone after cord clamping

Experimental group

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.

Treatment:

Drug: ceftriaxone 1gm for intravenous infusion

Group B ceftriaxone before skin incision

Active Comparator group

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.

Treatment:

Drug: ceftriaxone 1gm for intravenous infusion