Comparison of cefazolin and cefazolin plus azithromycin regimens in prevention of infection in caesarean section in Shahid Sayyad Shirazi hospital , 2017-2019
Determining the effect of two cefazolin prophylaxis regimens alone and cefazolin plus azithromycin in the prevention of infections caused by cesarean delivery at Shahid Sayyad Shirazi Hospital.
Design
To randomize the first sample, the azithromycin group receiving cefazolin and the second sample will be assigned to the cefazolin group, and this process will proceed to the end of the sampling. An individual who compares the results of the two groups is unaware of the type of intervention. The final sample size was 125 in each group. A total of 250 people will be included in the study.
Settings and conduct
In this study, pregnant women over 18 years of age with a gestational age greater than 28 weeks plus Premature Rupture of Membranes (PROM) who will undergo emergency cesarean delivery at Shahid Sayyad Shirazi Hospital during the years 2017-2109 will be included. Pregnant women with inclusion criteria were randomly divided into two groups: 1) the group receiving azithromycin and cefazolin before surgery; 2) the group receiving cefazolin before surgery; then, the two groups matched the gestational age and the PROM They will be.
Participants/Inclusion and exclusion criteria
Pregnant women over 18 years of age with a gestational age greater than 28 weeks plus PROM or PPROM who will be placed at the Shaheed Sayyid Shiraz Hospital during the delivery of emergency cesarean section during 2017-2017.
Intervention groups
The group received a single dose of 500 mg oral azithromycin plus 2 g intravenous cefazolin and another 2 g intravesical cefazolin half an hour before surgery.
Main outcome variables
the rate of infection of the cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190609043847N1
Registration date:2019-07-23, 1398/05/01
Registration timing:retrospective
Last update:2019-07-23, 1398/05/01
Update count:0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Zeinab Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 0621
Email address
dr.jalali.z@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
2017-11-21, 1396/08/30
Actual recruitment end date
2019-04-20, 1398/01/31
Trial completion date
2019-04-20, 1398/01/31
Scientific title
Comparison of cefazolin and cefazolin plus azithromycin regimens in prevention of infection in caesarean section in Shahid Sayyad Shirazi hospital , 2017-2019
Public title
Prevention of post-cesarean infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female candidates for non-elective cesarean section,
gestational age of 28 weeks and more,
no history of infection before surgery,
no use of any antibiotic within a week,
no use of any antibiotic other than the antibiotics studied,
no history Allergy to any medication
preterm rupture of membranes less than 24 hours.
Exclusion criteria:
Sensitivity to cefazolin or azithromycin
Patient unwillingness
Get systemic antibiotic in the last 2 weeks
Fever prior to cesarean delivery
Preterm rupture of membranes more than 24 hours.
Get Immunosuppressive Drugs
Diseases such as diabetes and immune deficiency
Liver disease
Kidney and heart failure or pulmonary edema
multiple pregnancy
pre-eclampsia
urinary tract infection or pneumonia
Duration of surgery for more than an hour
the insertion of subcutaneous ducts during surgery,
Abnormal adhesion of placenta
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
250
Actual sample size reached:
250
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the first sample, the azithromycin group receiving cefazolin and the second sample will be assigned to the cefazolin group, and this process will proceed to the end of the sampling. An individual who compares the results of the two groups is unaware of the type of intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
No. 4, Boali Ave., Pasdaran Blve, Gorgan
City
Gorgan
Province
Golestan
Postal code
4916673353
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.Goums.REC.1396.285
Health conditions studied
1
Description of health condition studied
Infection caused by cesarean delivery
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
2
Description of health condition studied
Infection following a procedure
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
the incidence of post-cesarean infection
Timepoint
Infection is recorded two to ten days after admission.
Method of measurement
The secretion, erythema, and severe swelling of the site, as well as persistent fever, are checked
Secondary outcomes
empty
Intervention groups
1
Description
The first group received cefazolin 2 g in 30 minutes before cutting
Category
Prevention
2
Description
The second group received 2 grams in 30 minutes of cefazolin before cutting + 500 mg of oral Azithromycine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi hospital
Full name of responsible person
Zeinab Jalali
Street address
No. 4, Boali Ave, Pasdaran Blve, Gorgan.
City
Gorgan
Province
Golestan
Postal code
4916673353
Phone
+98 17 3225 0621
Email
dr.jalali.z@goums.ac.ir
Web page address
http://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohamad Reza Honarvar
Street address
Gorgan University of Medical Sciences, Hirkan Blve, Gorgan