drugset / Trial / NCT02742948

The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section

NCT02742948

Phase 2 Unknown 600 enrolled Cairo University
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2016-04
Primary completion
2016-08
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftriaxone Other / unclassified 2 g Intravenous

Indications