CClinicalTrials.gg
Status unknownNCT04009772Updated Jul 5, 2019

Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section

A Phase 2/3 interventional study of Cefepime and Cefuroxime plus Metronidazole in Emergency Cesarean Section and Infection Wound, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Assiut University · Phase 2/3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

Read the detailed description

This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.

Outcomes will include fever, wound infection, and urinary tract infection.

02

Conditions studied

  • Emergency Cesarean Section
  • Infection Wound

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Keywords

  • Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 500 is above the median of 145 across 931 interventional studies indexed under Emergencies.

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Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • intrapartum caesarean section

Exclusion criteria

Exclusion Criteria:

  • evidence of infection
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    "Cefepime" , "Maxipime®" 1 gm

    Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision

    Drug: Cefepime

  • Active comparator
    "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500

    Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section

    Drug: Cefuroxime plus Metronidazole

Interventions

  • DrugCefepime

    Antibiotic prophylaxis

    Also known as: Maxipime

  • DrugCefuroxime plus Metronidazole

    Antibiotic prophylaxis

    Also known as: Zinnat plus Flagyl

06

What researchers measure

Primary outcomes

  1. Incidence of surgical site wound infection

    Examining the wound after one week of the surgery to detect any infection

    Time frame: one week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04009772
Lead sponsor
Assiut University
Collaborators
Yasser Esmat Mohammed
Responsible party
Osama Saber Thabet Abdalmageed (Consultant of Obstetrics and gynecology, Assiut University) — Principal investigator
First posted
Jul 5, 2019
Start date
Jul 1, 2019
Primary completion
Feb 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Jul 5, 2019

Study contacts

Abdalmageed Abdalmageed
Contact
drosamast@yahoo.com.au
+201007972027
Osama Abdalmageed
Contact
drosamast1981@gmail.com
01007972027

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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