Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Study Overview
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Brief Summary
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Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection

Detailed Description
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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

Official Title
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Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Conditions
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Prevention of Postpartum Sepsis

Intervention / Treatment
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* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised placebo controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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 | Drug: Metronidazole<br>* Metronidazole 500 mg intravenous stat dose prior to skin incision<br>* Other names: Flagyl;|
| Placebo Comparator: Control arm<br>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 | Drug: Metronidazole<br>* Metronidazole 500 mg intravenous stat dose prior to skin incision<br>* Other names: Flagyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of reducing surgical site infection | Incidence of surgical site infections | Seven days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | 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 | Seven days post-operatively |