The aim of this study was to compare a single dose of antibiotics administered intravenously with three doses of intravenous antibiotics in preventing infections after cesarean section. During one year of starting the project, 146 pregnant women referred to obstetric clinics in Zanjan and had indication for cesarean section or those who requested cesarean despite of medical advice, underwent cesarean section and then were assigned to receive a single dose or three doses of prophylactic antibiotics (cefazolin 2 g/IV) in the operating room after clamping cord. Rate of infection was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011275259N1
Registration date:2011-01-04, 1389/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-04, 1389/10/14
Registrant information
Name
Ahmadreza Mobaien
Name of organization / entity
Zanjan Univ.
Country
Iran (Islamic Republic of)
Phone
+98 24 1426 4072
Email address
mobaien@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
1996-10-01, 1375/07/10
Expected recruitment end date
1997-10-02, 1376/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single dose versus three doses antibiotic prophylaxis regimen for cesarean section
Public title
Prevention of infection after cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the number of vaginal examination of hospital stay less than or equal to four times, rupture of membranes for six hours or less, duration of hospitalization less than 24 hours, duration of surgery less than 60 minutes, gestational age more than 36 weeks, body mass index of less than 30.
Exclusion criteria: Fever prior to cesarean section, urinary symptoms, no possibility to follow-up for 10 days after the operation, presence of underlying diseases such as diabetes and hypertension, receiving oral or intravenous antibiotics before surgery due to other causes, cesarean due to lack of progress in the second stage of labor, history of corticosteroid use
Age
From 14 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy research of Zanjan University of Medical Sciences
Street address
Deputy research of Zanjan University of Medical Sciences, Azadi Sq, Zanjan-Iran
City
Zanjan
Postal code
Approval date
2006-09-23, 1385/07/01
Ethics committee reference number
585/2/6/19
Health conditions studied
1
Description of health condition studied
Infection following cesarean section
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
Symptoms of infection
Timepoint
During the hospital stay after a cesarean every six hours and then discharged on day 10
Method of measurement
check of Of fever, chills, cellulitis incision, discharge and tenderness of uterine incision
Secondary outcomes
empty
Intervention groups
1
Description
Cefazolin 2 g/IV single-dose, in the operating room after clamping the umbilical cord
Category
Prevention
2
Description
Cefazolin 2 g/IV, three doses, after clamping the cord, 6 hours and 48 hours after cesarean section
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital, Zanjan University of Medical Sciences
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy research of Zanjan University of Medical Sciences
Full name of responsible person
Alireza Biglari
Street address
Deputy research of Zanjan University of Medical Sciences, Azadi Sq, Zanjan-Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy research of Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobaien
Position
Tropical and Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of Infectious Diseases, valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
City
Zanjan
Postal code
Phone
+98 912 619 1730
Fax
Email
amobaien@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobaien
Position
Tropical and Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of Infectious Diseases, Valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
City
Zanjan
Postal code
Phone
+98 912 619 1730
Fax
Email
amobaien@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmadreza Mobaien
Position
Tropical and Infectious Diseases Specialist
Other areas of specialty/work
Street address
Department of Infectious Diseases, Valiasr Hospital, Sheikh Fazlolah ave, Zanjan, Iran
City
Zanjan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)