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Antibiotic Prophylaxis for Elective Cesarean Section

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02177994
Acronym
TOAPFECSACT
Enrollment
328
Registered
2014-06-30
Start date
2013-09-30
Completion date
2014-11-30
Last updated
2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Cesarian Section Wound Following Delivery

Keywords

Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection

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)

Interventions

DRUGceftriaxone 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)

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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 dayspostoperative 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

MeasureTime frameDescription
other post cesarean section maternal and neonatal infectionfollow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery1. 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026