Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Prevention of Postpartum Sepsis Clinical Trial

Official title:

Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04792710
• Other study ID #: PPS trial 1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 8, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2021
• Source: University of Pretoria
• Contact: Leon C Snyman, PhD
• Phone: +27834621818
• Email: leon.snyman[@]up.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prevention of Postpartum Sepsis
• Puerperal Infection

Intervention

Drug:
• Metronidazole
Metronidazole 500 mg intravenous stat dose prior to skin incision

Locations

Country	Name	City	State
South Africa	Kalafong Provincial Tertiary Hospital	Pretoria	Gauteng Province

Sponsors (1)

Lead Sponsor	Collaborator
University of Pretoria

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of reducing surgical site infection	Incidence of surgical site infections	Seven days post-operatively
Secondary	Efficacy of reducing urinary tact infections	Incidence of urinary tract infections	Three days post-operatively
Secondary	Efficacy of reducing postpartum endometritis	Incidence of endometritis	Seven days post-operatively