NCT04792710

Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of Pretoria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection

Detailed description

All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm

Conditions

• Prevention of Postpartum Sepsis

Interventions

Type	Name	Description
DRUG	Metronidazole	Metronidazole 500 mg intravenous stat dose prior to skin incision

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-03-31
• Completion: 2022-06-30
• First posted: 2021-03-11
• Last updated: 2021-03-11

Locations

1 site across 1 country: South Africa