Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

University of Pretoria (UP)

Status and phase: Unknown; Phase 4

Conditions: Prevention of Postpartum Sepsis

Treatments: Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04792710

PPS trial 1

Details and patient eligibility

About

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

Full 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

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

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

Treatment:

Drug: Metronidazole

Control arm

Placebo Comparator group

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

Treatment:

Drug: Metronidazole