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Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Sponsor
University of Pretoria (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04792710
Collaborator
(none)
1,000
Enrollment
1
Location
2
Arms
15.7
Anticipated Duration (Months)
63.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised placebo controlled trialRandomised placebo controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
The out comes assessor will not have access to the arm the patient was randomised to.
Primary Purpose:
Prevention
Official Title:
Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
Anticipated Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

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
Metronidazole 500 mg intravenous stat dose prior to skin incision
Other Names:
  • Flagyl

    		•
    Placebo Comparator: Control arm

    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
    Metronidazole 500 mg intravenous stat dose prior to skin incision
    Other Names:
  • Flagyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of reducing surgical site infection [Seven days post-operatively]

      Incidence of surgical site infections

    Secondary Outcome Measures

    1. Efficacy of reducing urinary tact infections [Three days post-operatively]

      Incidence of urinary tract infections

    2. Efficacy of reducing postpartum endometritis [Seven days post-operatively]

      Incidence of endometritis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kalafong Provincial Tertiary Hospital Pretoria Gauteng Province South Africa

    Sponsors and Collaborators

    • University of Pretoria

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leon Snyman, Prof, University of Pretoria
    ClinicalTrials.gov Identifier:
    NCT04792710
    Other Study ID Numbers:
    • PPS trial 1
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Puerperal Infection
    Metronidazole

    Study Results

    No Results Posted as of Mar 11, 2021