The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Objective: To determine the optimal time for intravenous antibiotic prophylaxis administration in pregnant women undergoing elective cesarean section to minimize postpartum infectious complication for both the mother & neonate.

Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016 to September 2016.

Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g) immediately with skin incision & group C in which 200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping. Outcomes include postoperative maternal & fetal infectious morbidity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ceftriaxone

Criteria

Inclusion Criteria:

• pregnant women in singleton living healthy fetuses. gestational age (GA) more than 37 weeks gestation

Exclusion Criteria:

• Patients on immunosuppressant drugs, received any antibiotic prophylaxis (within 10 days), suffer any chronic illness (e.g. diabetes mellitus or renal disease) or who experienced any obstetric complication in the current pregnancy (e.g. antepartum hemorrhage & rupture of membranes). Previous history of more than two laparotomies, maternal BMI more than 28 & any maternal febrile illness within 10 days from the procedure. Patients who are known to be allergic to penicillin or cephalosporin