Comparison of single dose cefazolin versus single dose cefazolin plus seven days cephalexin prophylactic therapy on postoperative infections and early neonatal complications after elective cesarean section
To Compare administration of single dose cefazolin versus single dose cefazolin plus seven days cephalexin prophylactic therapy on the early neonatal complications in Bushehr Persian Gulf Martyrs Hospital during 2015-2016.Two hundred and four pregnant women who are going to be delivered by non emergency cesarean section will be randomly divided to intervention and control groups. Intervention group will receive single dose cefazolin and control group will receive single dose cefazolin and oral cephalexin for seven days. Inclusion criteria: gravid one women with normal BMI. Exclusion criteria: obese women, history of antibiotic consumption during one week prior to cesarean section, immunossupression, neonate with meconium stained amniotic fluid, duration of operation more than 30 minutes, patients with comorbidities.Mothers and their neonates will be visited in the first 48 hours and one week after delivery. Fever, chills, cellulitis, discharge from incision site, uterine tenderness in mother and diarrhea, rash and oral candidiasis in neonates will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506084339N10
Registration date:2015-07-10, 1394/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Bushehr University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-22, 1395/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single dose cefazolin versus single dose cefazolin plus seven days cephalexin prophylactic therapy on postoperative infections and early neonatal complications after elective cesarean section
Public title
Effect of administration of cefazolin in cesarean delivery on maternal postoperative infections and early neonatal complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
primi gravid; normal BMI
Exclusion criteria:
Obese women; history of antibiotic consumption in one week prior to cesarean section; immunosuppression; history of corticosteroid consumption; neonates with meconium stained amniotic fluid; duration of operation more than 30 minutes; patients with comorbidity.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
204
Randomization (investigator's opinion)
Randomized
Randomization description
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
Vice chancellor of research, Bushehr University of Medical Sciences
Street address
Bahmani Campus, Bushehr University of Medical Sciences, Sabzabad Blvd.
City
Bushehr
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
Bpums.rec.139
Health conditions studied
1
Description of health condition studied
Early neonatal complications (rash, diarrhea, oral candidiasis) and maternal infections after elective cesarean section
ICD-10 code
P83.9, P78
ICD-10 code description
Antibiotics associated rash, diarrhea and oral candidiasis in neonate and maternal genitourinary and surgical site infections
Primary outcomes
1
Description
Diarrhea, rash and oral candidiasis in neonate
Timepoint
During first 48 hours after delivery and one week postdelivery
Method of measurement
History and physical examination
Secondary outcomes
1
Description
Surgical site infection
Timepoint
During first 48 hours post delivery and one week post delivery
Method of measurement
History, physical examination
2
Description
Metritis
Timepoint
During first 48 hours post delivery and one week post delivery
Method of measurement
History, physical examination
3
Description
Urinary tract infection
Timepoint
During first 48 hours post delivery and one week post delivery
Method of measurement
History, physical examination, urinalysis and urine culture
4
Description
Breastfeeding satisfaction
Timepoint
During first 48 hours post delivery and one week post delivery
Method of measurement
History
Intervention groups
1
Description
Control group: administrating cefazolin 1gr IV after clamping umbilical cord plus oral cephalexin 500 mg QID for seven days to mothers.
Category
Treatment - Drugs
2
Description
Intervention group: administrating cefazolin 1gr IV to mothers after clamping umblical cord.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Martyrs Hospital
Full name of responsible person
Dr Elham Rahmani
Street address
Persian Gulf Martyrs Hospital, Borj square, Borj Blvd.
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Bushehr University of Medical Sciences