Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
Metronidazole 500 mg intravenous stat dose prior to skin incision
Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng, South Africa
Efficacy of reducing surgical site infection
Incidence of surgical site infections
Time frame: Seven days post-operatively
Efficacy of reducing urinary tact infections
Incidence of urinary tract infections
Time frame: Three days post-operatively
Efficacy of reducing postpartum endometritis
Incidence of endometritis
Time frame: Seven days post-operatively
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