Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Overview
- Phase
- Phase 4
- Intervention
- Metronidazole
- Conditions
- Prevention of Postpartum Sepsis
- Sponsor
- University of Pretoria
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Efficacy of reducing surgical site infection
- Last Updated
- 5 years ago
Overview
Brief 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
Investigators
Leon Snyman
Prof
University of Pretoria
Eligibility Criteria
Inclusion Criteria
- •18 years and older Willing and able to provide written informed consent
Exclusion Criteria
- •women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
Arms & Interventions
Intervention arm
This arm will be allocated to receive metronidazole 500 mg in addition to the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section as a once off dose
Intervention: Metronidazole
Control arm
This arm will be allocated to receive the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section plus a placebo of normal saline 50 ml administered intravenously as a once off dose
Intervention: Metronidazole
Outcomes
Primary Outcomes
Efficacy of reducing surgical site infection
Time Frame: Seven days post-operatively
Incidence of surgical site infections
Secondary Outcomes
- Efficacy of reducing urinary tact infections(Three days post-operatively)
- Efficacy of reducing postpartum endometritis(Seven days post-operatively)