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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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 |
|
| Control arm | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Metronidazole 500 mg intravenous stat dose prior to skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of reducing surgical site infection | Incidence of surgical site infections | Seven days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of reducing urinary tact infections | Incidence of urinary tract infections | Three days post-operatively |
| Efficacy of reducing postpartum endometritis | Incidence of endometritis |
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Inclusion Criteria:
18 years and older Willing and able to provide written informed consent
Exclusion Criteria:
Pregnant patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leon C Snyman, PhD | Contact | +27834621818 | leon.snyman@up.ac.za | |
| Louisa Seopela, MMed (O&G) | Contact | +27833014790 | drseopela@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalafong Provincial Tertiary Hospital | Pretoria | Gauteng | South Africa |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Randomised placebo controlled trial
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The out comes assessor will not have access to the arm the patient was randomised to.
| Seven days post-operatively |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |