Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
1 other identifier
interventional
1,000
1 country
1
Brief Summary
Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2021
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMarch 11, 2021
March 1, 2021
1.1 years
March 8, 2021
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of reducing surgical site infection
Incidence of surgical site infections
Seven days post-operatively
Secondary Outcomes (2)
Efficacy of reducing urinary tact infections
Three days post-operatively
Efficacy of reducing postpartum endometritis
Seven days post-operatively
Study Arms (2)
Intervention arm
EXPERIMENTALThis 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 COMPARATORThis 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
Interventions
Metronidazole 500 mg intravenous stat dose prior to skin incision
Eligibility Criteria
You may qualify if:
- years and older Willing and able to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng, South Africa
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The out comes assessor will not have access to the arm the patient was randomised to.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
March 8, 2021
Primary Completion
March 31, 2022
Study Completion
June 30, 2022
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share