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Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Sudan
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum
ClinicalTrials.gov Identifier:
NCT01347593
First received: May 2, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.


Condition Intervention Phase
Caesarean
 Drug: ceftizoxime
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Khartoum:

Primary Outcome Measures:
  • reducing post Cesarean section febrile morbidity [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    reducing infection rate


Enrollment: 220
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ceftizoxime (cefizox) injection
ceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision
 Drug: ceftizoxime
ceftizoxime (cefizox) injection either after clamping the cord
Other Name: cefizox

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective Cesarean section

Exclusion Criteria:

  • Diabetes severe anaemia allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347593

Locations
Sudan
Soba Hospital
Khartoum, Sudan, 249
Sponsors and Collaborators
University of Khartoum
Ministry of Health, Sudan
  More Information

No publications provided by University of Khartoum

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01347593     History of Changes
Other Study ID Numbers: ceftizoxime cesarean
Study First Received: May 2, 2011
Last Updated: January 16, 2013
Health Authority: Federal Ministry of health, Sudan:

Keywords provided by University of Khartoum:
ceftizoxime
Cesarean
post caesarean febrile morbidity

Additional relevant MeSH terms:
Ceftizoxime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013