Comparison of the effect of prophylaxis antibiotic before and during operation on maternal and neonatal outcomes in pregnant women candidate for elective cesarean section
Comparison of the effect of prophylaxis antibiotic before and during operation on maternal and neonatal outcomes in pregnant women candidate for elective cesarean section
Design
After explaining the purpose of the study and obtaining the informed consent, patients under cesarean section will be allocated as parallel into A (intervention) and B (control) groups. Sample size: 360 participate in the study with 180 patients in each group
Settings and conduct
The study is single-center and phase 3 trial. Randomization will be performed using random block sizes of 4.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age greater than 34 weeks
Exclusion criteria: Antibiotic use in the past two weeks; The temperature greater than 38 at least 2 times at intervals of 6 hours in the axillary region during surgery; Sensitivity to cefazolin antibiotics
Intervention groups
Intervention group: Cefazolin 2 gr, 15-30 minutes before surgery
Control group: Cefazolin 2 gr, 15-30 minutes after exit the placenta
Comparison of the effect of prophylaxis antibiotic before and during operation on maternal and neonatal outcomes in pregnant women candidate for elective cesarean section
Public title
Effect of prophylaxis antibiotic before and during operation on maternal and neonatal outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age greater than 34 weeks
Exclusion criteria:
Antibiotic use in the past two weeks
The temperature greater than 38 at least 2 times at intervals of 6 hours in the axillary region during surgery
Sensitivity to cefazolin antibiotics
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
360
Randomization (investigator's opinion)
Randomized
Randomization description
using random block sizes of 4
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, Vice chancellor for research, Shahroud University of Medical Sciences
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
3613773955
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
IR.SHMU.REC.1394.169
Health conditions studied
1
Description of health condition studied
Elective cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Endometritis
Timepoint
Before surgery and 1 week and 2 weeks after surgery
Method of measurement
Clinical evaluation
2
Description
Wound infection
Timepoint
Before surgery and 1 week and 2 weeks after surgery
Method of measurement
Clinical evaluation
3
Description
Urinary tract infection
Timepoint
Before surgery and 1 week and 2 weeks after surgery
Method of measurement
Clinical evaluation
4
Description
Apgar Score
Timepoint
At birth
Method of measurement
Clinical evaluation
5
Description
Hypothermia
Timepoint
At birth
Method of measurement
Clinical evaluation
6
Description
Tachypnea
Timepoint
At birth
Method of measurement
Clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cefazolin 2 gr, 15-30 minutes before surgery
Category
Treatment - Drugs
2
Description
Control group: Cefazolin 2 gr, 15-30 minutes after exit the placenta
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar hospital
Full name of responsible person
Hanise Akbarzade
Street address
22 bahman St
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 4499
Email
akbarzade@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
7 Tir square
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 4499
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hanise Akbarzade
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7 Tir square
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 4499
Email
akbarzade@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Sekine Kolahdoozan
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7 Tir square
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 4499
Email
kolahdoozan@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hanise Akbarzade
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
7 Tir square
City
Shahroud
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 4499
Email
akbarzade@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available