drugset / Trial / NCT02736682

Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section.

NCT02736682

Phase 4 Completed 174 enrolled Makerere University
RandomizedCrossoverOpen-labelTreatment

Summary

Delivery by Cesarean section is increasing worldwide and this is the most important risk factor for post partum infection where there is a 5-20% risk of developing post partum infection than women who deliver vaginally Provision of single dose broad spectrum intravenous antibiotics 30-60 minutes before cesarean section has been found to be as effective as multiple doses in reducing post operative infections. At Mulago National referral Hospital mothers who have had elective and are at low risk of post partum infection also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of the study is to further inform us that single dose preoperative antibiotic prophylaxis is effective in prevention of post operative infection in mothers delivered by elective cesarean section.

Timeline

Start
2015-09
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftriaxone Other / unclassified 1 g Intravenous
Subject Ceftriaxone Other / unclassified 2 g Intravenous
Subject Metronidazole Small molecule 500 mg Intravenous

Indications