Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Primary Purpose
Prevention of Postpartum Sepsis
Status
Unknown status
Phase
Phase 4
Locations
South Africa
Study Type
Interventional
Intervention
Metronidazole
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Postpartum Sepsis
Eligibility Criteria
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
Sites / Locations
- Kalafong Provincial Tertiary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention arm
Control arm
Arm Description
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
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
Outcomes
Primary Outcome Measures
Efficacy of reducing surgical site infection
Incidence of surgical site infections
Secondary Outcome Measures
Efficacy of reducing urinary tact infections
Incidence of urinary tract infections
Efficacy of reducing postpartum endometritis
Incidence of endometritis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04792710
Brief Title
Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Official Title
Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2021 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Postpartum Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised placebo controlled trial
Masking
Outcomes Assessor
Masking Description
The out comes assessor will not have access to the arm the patient was randomised to.
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
Metronidazole 500 mg intravenous stat dose prior to skin incision
Primary Outcome Measure Information:
Title
Efficacy of reducing surgical site infection
Description
Incidence of surgical site infections
Time Frame
Seven days post-operatively
Secondary Outcome Measure Information:
Title
Efficacy of reducing urinary tact infections
Description
Incidence of urinary tract infections
Time Frame
Three days post-operatively
Title
Efficacy of reducing postpartum endometritis
Description
Incidence of endometritis
Time Frame
Seven days post-operatively
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leon C Snyman, PhD
Phone
+27834621818
Email
leon.snyman@up.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
Louisa Seopela, MMed (O&G)
Phone
+27833014790
Email
drseopela@yahoo.com
Facility Information:
Facility Name
Kalafong Provincial Tertiary Hospital
City
Pretoria
State/Province
Gauteng Province
Country
South Africa
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon c Snyman, PhD
Phone
+27834621818
Email
leon.snyman@up.ac.za
First Name & Middle Initial & Last Name & Degree
Louisa Seopela, MMed (O&G)
Phone
+27833014790
Email
drseopela@yahoo.com
First Name & Middle Initial & Last Name & Degree
Randy Lamfel, MBChB
12. IPD Sharing Statement
Plan to Share IPD
No
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Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
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