Prevention of Postpartum Sepsis
Conditions
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
Interventions
DRUGMetronidazole
Metronidazole 500 mg intravenous stat dose prior to skin incision
Sponsors
University of Pretoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The out comes assessor will not have access to the arm the patient was randomised to.
Intervention model description
Randomised placebo controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of reducing surgical site infection | Seven days post-operatively | Incidence of surgical site infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Africa
Contacts
Primary ContactLeon C Snyman, PhD
Backup ContactLouisa Seopela, MMed (O&G)
Outcome results
None listed