Antibiotic Prophylaxis for Elective Cesarean Section

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Infection of Cesarian Section Wound Following Delivery

Intervention / Treatment
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* Drug: ceftriaxone 1gm for intravenous infusion


Participation Criteria
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Eligibility Criteria
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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). 3) Morbid obesity (BMI>30)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A ceftriaxone after cord clamping<br>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. | Drug: ceftriaxone 1gm for intravenous infusion<br>* 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)<br>* Other names: cefaxon;|
| Active Comparator: Group B ceftriaxone before skin incision<br>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. | Drug: ceftriaxone 1gm for intravenous infusion<br>* 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)<br>* Other names: cefaxon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the rate of post cesarean section surgical site infection. | 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). | administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other post cesarean section maternal and neonatal infection | 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 | follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection