Comparison of efficacy of prophylactic antibiotic prescribing before cesarean section and antibiotic administration after cord clamping on prevention of post-cesarean infection
Comparison of efficacy of prophylactic antibiotic prescribing before cesarean section and antibiotic administration after cord clamping on prevention of post-cesarean infection
Design
A clinical trial with a sample size of 180 patients with intervention and control groups, with parallel group design, triple blind, randomized, phase 3
Settings and conduct
This study will be conducted at Shahidan Mobinini Hospital in Sabzevar. People will be randomly divided into two groups; Follow up of mothers will be performed by the physician within the first 48 hours after cesarean section (during admission).
In the absence of infection symptoms, patients will be discharged on day 2 and then will be investigated on day 7-10. They will inform us if they have any problem until the 14th day after the cesarean section.
Blinding: The patient, the project manager and his assistant, and the design consultant are not aware of the contents of the prescribed drug packs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women who are referred for cesarean section according to indication. Non-inclusion criteria: taking antibiotics 24 hours before C/S, underlying illness, presence of Chorioamnionitis criteria, fever, use of immunosuppressive drugs.
Intervention groups
Intervention group: 90 pregnant women receiving antibiotics immediately after umbilical cord clamp and distilled water one hour before cesarean delivery. Control group: 90 pregnant women receiving antibiotics immediately after cesarean section and distilled water immediately after umbilical cord clamp.
Main outcome variables
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190526043710N1
Registration date:2019-08-05, 1398/05/14
Registration timing:retrospective
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Zeinab Shahbazzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7773 4246
Email address
shahbazzadez90@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-14, 1398/03/24
Expected recruitment end date
2019-07-10, 1398/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of prophylactic antibiotic prescribing before cesarean section and antibiotic administration after cord clamping on prevention of post-cesarean infection
Public title
Comparison of efficacy of anitibitic befor and after C/S to prevent post_cesarean infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who undergo C/S due to midwifery indications or other reasons
Providing informed consent
Exclusion criteria:
Having underlying dieases (DM, liver dieases, kidney dieases, suppressd immune sys)
The presence of chorioamnionitis criteria (loshia, tenderness, fever)
Fever (oral temperature above 38 degrees)
Rupture of memberans more than 24 hours
Immunosuppressive drugs use (corticosteroids and etc)
Use of antibiotics 24 hours before cesarean section
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization Tool: Random Number Tables
How to create a random sequence: A random number table using www.randomization.com
Hiding: Hiding in this study will be done by the central service and people who do not have any information about the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be treated by prescription drug packs (which are quite similar in appearance).Patient and executor are not aware of the contents of packages. Information gathering, patient assessment and completion of the forms will be carried out by the executor and her assistant who are not aware of the contents of packages. The data analysis will also be done by the statistician who is not aware of packages contents and only is aware of the grouping (group 1 or 2). Therefore, the study is a triple blinded study and the patient's arrival stage to the study, data collection and analysis, the contents of the packs will not be determined.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohidshahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.MEDSAB.REC.1398.015
Health conditions studied
1
Description of health condition studied
Comparison of efficacy of antibiotic prescribing before and after cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of post Cesarean infection
Timepoint
During the Hospitalization and 10 or 14 days after cesarean section
Method of measurement
Physical examination and judgment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 90 pregnant mothers eligible for inclusion in the study will be prescribed antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) after clamping the umbilical cord and Distilled water one hour before making the cut (cesarean section).
Category
Prevention
2
Description
Control group: 90 pregnant mothers eligible for inclusion in the study will be taken antibiotics (routinely: single dose Cefazolin 1 g in subjects weighing less than 80 kg - 2 g in subjects weighing 80 kg or more- 3 g in subjects With a weight greater than 120 kg, and in the case of allergy to penicillin, combine therapy with Metronidazole 100 mg or 600 mg of Clindamycin with Gentamycin 1.5 mg / kg body weight) One hour before making the cut (cesarean section) and distilled water immediately after cord clamping.