Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section.

NCT02736682

Post Operative Infections

COMPLETED PHASE4

Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population

NCT06154720

Surgical Site Infection

COMPLETED

Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

NCT01721616

Endometritis

WITHDRAWN PHASE4

Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

NCT04163679

Infection Obstetric Labor Complications Endometritis +2 more

TERMINATED NA

Effectiveness for Interventions to Minimize Surgical Site Infections

NCT01153191

Infections

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention of Postpartum Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised placebo controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The out comes assessor will not have access to the arm the patient was randomised to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

Metronidazole 500 mg intravenous stat dose prior to skin incision

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

Group Type PLACEBO_COMPARATOR

Metronidazole

Intervention Type DRUG

Metronidazole 500 mg intravenous stat dose prior to skin incision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metronidazole

Metronidazole 500 mg intravenous stat dose prior to skin incision

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flagyl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No