NCT01347593

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

May 2, 2011

Last Update Submit

January 16, 2013

Conditions

Caesarean

Keywords

ceftizoximeCesareanpost caesarean febrile morbidity

Outcome Measures

Primary Outcomes (1)

  • reducing post Cesarean section febrile morbidity

    reducing infection rate

    4 days

Study Arms (1)

ceftizoxime (cefizox) injection

EXPERIMENTAL

ceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision

Drug: ceftizoxime

Interventions

ceftizoximeDRUG

ceftizoxime (cefizox) injection either after clamping the cord

Also known as: cefizox
ceftizoxime (cefizox) injection

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Elective Cesarean section

You may not qualify if:

  • Diabetes severe anaemia allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soba Hospital

Khartoum, Khartoum State, 249, Sudan

Location

Related Publications (1)

  • Osman B, Abbas A, Ahmed MA, Abubaker MS, Adam I. Prophylactic ceftizoxime for elective cesarean delivery at Soba Hospital, Sudan. BMC Res Notes. 2013 Feb 8;6:57. doi: 10.1186/1756-0500-6-57.

    PMID: 23394621DERIVED

MeSH Terms

Interventions

Ceftizoxime

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

SU(1)