Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.
Comparing the efficacy of prophylactic first- generation cephalosporin alone, with a first- generation cephalosporin plus azithromycin in reducing wound infection and endometritis after emergency cesarean section is the objective of this study.
Inclusion: spontaneously labor or induced labor; rupture of membranes within 4 hour prior the termination; meconium passage before section and non-cephalic presentation.
Exclusion: diabetes; multiple Pregnancy; history of Azitromycine or Erythromicine used in one last week; clinical finding about corioamniotitis; pulmonary edema; immunosupretion; Aids; patients who could not follow up after Cesarean section; preeclampsia; rapture of membrane more than 18 hour.
This randomized controlled double blind clinical trial was done on 424 women over 14 year with gestational age more than 24 week who underwent emergency cesarean in Shariati Hospital in Bandar Abbas during 2011 July until 2012 August.
Patients randomly divided to case and control group. Keflin 2 gram Intera Venus was prescribed 0.5 hour before surgery for both case and control groups. Case group also received azithromycin 1 gram oral 0.5 hour before surgery and control group received placebo. Patients were under observed till 1 month after surgery. Fever; open wound; endometritis and hospitalization were compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041017211N1
Registration date:2014-05-05, 1393/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Maryam Iranfar
Name of organization / entity
HORMOZGAN University of medical Sciences (HUMS)
Country
Iran (Islamic Republic of)
Phone
+98 76 1333 3280
Email address
iranfar.maryam@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.
Public title
Compare effectiveness of broad spectrum antibiotic prophylaxy (Azitromycin + Keflin) with Keflin to prevent of post C/S infection in ER of Dr. Shariaty Hospital patient since 2011 July till 2012 August.
Purpose
Prevention
Inclusion/Exclusion criteria
The single most important risk factor for postpartum maternal infection is cesarean section. Women undergoing cesarean section have greater risk for infection and infectious morbidity compared with a vaginal birth. The objective of this study is to determine if extended spectrum prophylactic antibiotic treatment (cefazolin and azithromycin) reduces post-cesarean delivery infections.
Inclusion: spontaneously labor or induced labor; rupture of membranes within 4 hour prior the termination; meconium passage before section and non-cephalic presentation.
Exclusion: diabetes; multiple Pregnancy; patients who have contraindication to receive antibiotics; history of Azitromycine or Erythromicine used in one last week; clinical finding about corioamniotitis; pulmonary edema; immunosupretion; Aids; patients who could not follow up after Cesarean section; significant renal disease; preeclampsia; rapture of membrane more than 18 hour.
This randomized controlled double blind clinical trial was done on 424 women over 14 year with gestational age more than 24 week who underwent non- elective cesarean in Shariati Hospital in Bandar Abbas during 2011 July until 2012 August.
Patients randomly divided to case and control group. Keflin 2 gram Intera Venus was prescribed 0.5 hour before surgery for both case and control groups. Cases also received azithromycin 1 gram oral 0.5 hour before surgery. Patients were under observed till 1 month after surgery. Fever; open wound; endometritis and hospitalization were compared between two groups.
Age
From 14 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
424
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology Hormozgan University of Medical Sciences, Bandar Abbas,
Street address
East side of Shahid Mohammadi Hospital, Islamic Republic of Iran BLVD
City
Bandar Abbas
Postal code
79145-3835
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
HEC-91-9-7
Health conditions studied
1
Description of health condition studied
To prevent post C/S infection
ICD-10 code
082.1
ICD-10 code description
Delivery by emergency caesarean section
Primary outcomes
1
Description
Fever
Timepoint
After intervention
Method of measurement
Thermometer in degrees Celsius
2
Description
Endometritis
Timepoint
After intervention
Method of measurement
Based on clinical symptoms such as fever, malodorous discharge and uterine tenderness
3
Description
Wound infection
Timepoint
After intervention
Method of measurement
Number of open stitches
Secondary outcomes
1
Description
Length of stay
Timepoint
After intervention
Method of measurement
Days of hospitalization after surgery
Intervention groups
1
Description
Control Group received Cephalotin 2gr IV and placebo 1gr oral. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients.
Category
Prevention
2
Description
Case group received Azithromycin and Cephalotin as a preoperative antibiotic prophylaxis. These drugs were given only one dose before surgery. These groups of patients were admitted under full supervisioning 48 hours after surgery, and if fever was observed in each one, then she must be due to more time under supervisioning for differential diagnosis of the fever. After discharging, all of these patients were followed up for any sign of fever, endometritis and wound infection, for a month.
Patients themselves, nurses and gynecologist those who followed up the postoperative of patients were unaware of the group and kind of drugs given to patients.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. SHARIATI Specialized Hospital of Obstetrics and Gynecology