Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Phase 4

• Conditions: Prevention of Postpartum Sepsis
• Interventions: Drug: Metronidazole

• Registration Number: NCT04792710
• Lead Sponsor: University of Pretoria

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

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-08
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11
• Primary Completion: 2022-03-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Metronidazole	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 arm	Metronidazole	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

Primary Outcome Measures

Name	Time	Method
Efficacy of reducing surgical site infection	Seven days post-operatively	Incidence of surgical site infections

Secondary Outcome Measures

Name	Time	Method
Efficacy of reducing urinary tact infections	Three days post-operatively	Incidence of urinary tract infections
Efficacy of reducing postpartum endometritis	Seven days post-operatively	Incidence of endometritis

Trial Locations

Locations (1)

Kalafong Provincial Tertiary Hospital; 🇿🇦 Pretoria, Gauteng Province, South Africa