The effect of antibiotic administration on prevention of post-cesarean infection
Design
A randomized, double-blind, clinical trial, parallel group
Settings and conduct
In this study, patients were divided into two groups of three doses of antibiotics and no antibiotics. Simple randomization is used for this study and the effect of these two regimens on preventing post-cesarean section infection was evaluated.
Participants/Inclusion and exclusion criteria
All patients undergoing elective cesarean section at Sarem Specialty Hospital are included in the study.
Inclusion criteria: In this study only women who had elective cesarean section without any indication of risk
Exclusion criteria: In this study, women with diabetes, preeclampsia, obesity and BMI over 30, abdominal wall enlargement, etc. Or their cesarean section with any reason is longer than usual, such as placenta adhesion.
Intervention groups
Group 1: They receive three doses of antibiotics after surgery.
Group 2: They do not receive any antibiotics after surgery.
Main outcome variables
Determination of wound infection rate in cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190902044667N1
Registration date:2019-11-13, 1398/08/22
Registration timing:registered_while_recruiting
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Mozhgan Karamnia Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0883
Email address
dr.karamnia@saremhospital.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of differences in post-cesarean section infection following three-dose prophylactic regimen with no prescription of antibiotics
Public title
Antibiotic prescription after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have had elective caesarean section without any risky indication
Exclusion criteria:
History of diabetes, preeclampsia, obesity and BMI over 30
Prolonged cesarean section is longer than usual
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used to perform this study and by throwing dice.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the national protocol prescribing an antibiotic dose one hour before surgery is essential for all patients.The design of the study is that all patients undergoing elective caesarean section in the Sarem Specialty Hospital will be conducted as a single-blind study. Data collection and analysis will be done by the statistician who does not have any information about the intervention and control groups.
Patients are divided into two groups:
Group 1: They receive three doses of antibiotics after surgery.
Group 2: They do not receive any antibiotics after the operation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemat Highway next to MMilad, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.IUMS.REC.1396. 23099608822
Health conditions studied
1
Description of health condition studied
Antibiotic prescription after cesarean section
ICD-10 code
T81.4
ICD-10 code description
عفونت بدنبال سزارین
Primary outcomes
1
Description
Symptoms of infection
Timepoint
Before intervention, the data of these patients were recorded And followed up for 40 days after intervention and discharge And their information is recorded.
Method of measurement
Questionnaire to record patient demographic information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: They receive a dose of antibiotic after surgery.
Category
Diagnosis
2
Description
Intervention group 2: They receive three doses of antibiotics after surgery.
Category
Diagnosis
3
Description
Intervention group 3: They do not receive any antibiotics after surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
sarem women hospital
Full name of responsible person
Dr. Mojgan Karamnia far
Street address
Phase 3- Ekbatan Town, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
dr.karamnia@saremhospital.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sarem Fertility and Infertility Research Center
Full name of responsible person
Maryam Mahmoodinia Maymand
Street address
Phase 3- Ekbatan Town, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
dr.karamnia@saremhospital.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sarem Fertility and Infertility Research Center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Sarem Infertility Fertility Research Center
Full name of responsible person
Dr. Mojgan Karamnia far
Position
Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Phase 3- Ekbatan Town, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
dr.karamnia@saremhospital.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sarem Fertility and Infertility Research Center
Full name of responsible person
Dr. Mojgan Karamnia far
Position
Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Phase 3- Ekbatan Town, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0883
Email
dr.karamnia@saremhospital.org
Person responsible for updating data
Contact
Name of organization / entity
Sarem Fertility and Infertility Research Center
Full name of responsible person
Dr. Mojgan Karamnia far
Position
Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Phase 3- Ekbatan Town, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
009844670883
Email
dr.karamnia@saremhospital.org
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