Protocol summary

Summary
The purpose of this study was to compare the prophylactic administration of cefazolin , ampicillin and azithromycin in the prevention of postpartum infections after cesarean. A total of 375 patients with non-elective cesarean candidates are placed randomly in three groups of 125 individuals. Inclusion criteria include non-elective caesarean section women candidates, gestational age 28 weeks or more. Exclusion criteria are hypersensitivity to cefazolin or ampicillin, or azithromycin; unwillingness patient; received systemic antibiotics within 2 weeks, prior cesarean delivery fever, PROM more than 18 hours, chorioamnionitis; receiving immunosuppressive drugs, the risk of diseases such as diabetes and immune deficiency: liver disease, kidney disease and heart failure or pulmonary edema active, have multiple pregnancies, preeclampsia, urinary tract infection or pneumonia, duration greater than one hour during subcutaneous drains. First group receive 2 g of cefazolin in 30 to 60 minutes before cutting. Second group receive regimen of 2 g of cefazolin in 30 to 60 minutes before cutting + 500 mg intravenous azithromycin and third group receive regimen of ampicillin 2 g in 30 to 60 minutes before cutting + 500 mg intravenous azithromycin. Determine the incidence of puerperal infection after cesarean section in all 3 groups at discharge, 2-week and 6-week and hospitalization period is recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013080710511N2
Registration date: 2013-08-21, 1392/05/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-21, 1392/05/30
Registrant information
Name
Maryam Karamali
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
dr.karamali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic administration of cefazolin, ampicillin and azithromycin in prevention of postpartum infections after cesarean
Public title
Comparison of prophylactic administration of cefazolin, ampicillin and azithromycin in prevention of postpartum infections after cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were: Non-elective Caesarean section women candidates; Gestational age of 28 weeks and more. Exclusion criteria were: Sensitivity to cefazolin or ampicillin or azithromycin; Unwillingness of patients; Received systemic antibiotics within 2 last weeks; Fever prior cesarean; PROM more than 18 hours; chorioamnionitis; Receiving immunosuppressive drugs; Diseases such as diabetes and immune deficiency: liver disease, kidney disease and heart failure or pulmonary edema; multiple pregnancies; preeclampsia; Urinary tract infection or pneumonia; Operation for more than an hour; Intraoperative subcutaneous drains; Abnormal adherence of the placenta to be observed during operation; Elective caesarean; Diarrhea at the time of delivery; Any patient with significant electrolyte disturbances such as hypokalemia, hypocalcemia.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 375
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
Arak University of Medical Sciences
Street address
Arak, Sardasht, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
91-130-11

Health conditions studied

1

Description of health condition studied
postpartum infection
ICD-10 code
085-092
ICD-10 code description
Complications predominantly related to the puerperium

Primary outcomes

1

Description
postpartum infection
Timepoint
Discharge, 2 weeks and 6 weeks after surgery
Method of measurement
Fever, abdominal pain, uterine tenderness, erythema, and purulent discharge from the wound

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
Study duration
Method of measurement
Medical record

Intervention groups

1

Description
receiving routine prophylactic (cefazolin 2 g of 30 to 60 minutes before cutting)
Category
Prevention

2

Description
regimen of 2 g of cefazolin in 30 to 60 minutes before cutting + 500 mg intravenous azithromycin
Category
Prevention

3

Description
regimen of ampicillin 2 g in 30 to 60 minutes before cutting + 500 mg intravenous azithromycin
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Taleghani Hospital
Full name of responsible person
Dr. Maryam Karamali
Street address
Arak, Emam Khomeini Street
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saeid Ashtiani
Street address
Arak, Sardasht, Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Maryam Karamali
Position
Spesialist in Obestetrics & Gynocology/ Assistant Professor
Other areas of specialty/work
Street address
Arak, Emem Khomaini Street, Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
dr.karamali@arakmu.ac.ir; drkaramali88@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Maryam Karamali
Position
Spesialist in Obestetrics & Gynocology
Other areas of specialty/work
Street address
Arak, Emam Khomaini Street, Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
dr.karamali@arakmu.ac.ir; drkaramali88@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Maryam Karamali
Position
Spesialist in Obestetrics & Gynocology/ Assistant Professor
Other areas of specialty/work
Street address
Arak, Emam khomaini Street,Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
dr.karamali@arakmu.ac.ir; drkaramali88@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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