This study is a clinical trial of 231 pregnant women undergoing elective Caesarean section in Mordad 1391 from Bandar Abbas in Persian date Mordad 1392 Shariati Hospital were enrolled. The use of azithromycin and cephalexin antibiotic to prevent infection and reduce hospital stay following cesarean section in obese patients.
Inclusion criteria: pregnant women with more than fourteen years of age; BMI over thirty; thirty-seven weeks of pregnancy; and the Indications for elective cesarean section.
Exclusion criteria: Pregnant women with a history of diabetes; Hypertension; Connective tissue diseases; History of PROM; Twin; Antibiotic therapy. Control group received 2 g IV Keflin half hour before surgery for antibiotic prophylaxis and 48 hours after C/S, 500 mg every 6 hours cephalexin placebo and 250 mg azithromycin placebo was administered every 12 hours for them.
The intervention group as the control group received, 2 g IV Keflin half hours before surgery for antibiotic prophylaxis and 48 hours after C/S, 500 mg every 6 hours cephalexin and 250 mg every 6 hours with 250 mg azithromycin every 12 hours was prescribed for them. Patients within 48 hours of hospitalization and up to one month after the c-section out of any fever, endometritis, wound infection , and symptoms were monitored and followed up . During this month, the clinic had any fever or infections were seen at the end of the month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041017212N1
Registration date:2014-06-16, 1393/03/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Maryam Abbasian
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 496 4012
Email address
maryam.abbasian@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between azithromycin and cephalexin for preventing infection after cesarean section in obese patients
Public title
Reduction of infection after caesarean section in obese women with antibiotic prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
In this study, 222 pregnant women aged over 14 years; BMI> 30; with a gestational age of 37 weeks or older; who are undergoing elective cesarean section; can be selected. Exclusion criteria included: pregnant women aged over 14 years; BMI> 30; with a gestational age of 37 weeks or older; who are undergoing elective cesarean section with a history of diabetes; HTN; history of connective tissue diseases; and PROM; twin; antibiotics therapy during recent weeks. Initially weight - height and BMI calculated and those with BMI> 30 were selected and randomly divided into two groups. Both intervention group and control group in terms of demographic characteristics, duration of surgery, surgical techniques are the same.
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:
222
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
Hormozgan University of Medical Siences
Street address
ُShahid Naser Ave., Dr Shariati Hos., Bandar abbas
City
Bandar Abbas
Postal code
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
HEC-91-9-6
Health conditions studied
1
Description of health condition studied
Elective caesarean section in obese wemen
ICD-10 code
O82.8
ICD-10 code description
Other single delivery by caesarean section
Primary outcomes
1
Description
Infection after surgery
Timepoint
after C/S, 1 week, 2 weeks, 3 weeks and 4 weeks after C/S
Method of measurement
Observe
Secondary outcomes
empty
Intervention groups
1
Description
This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas, Shariati Hospital was performed. The intervention group the same as control group received 2 g Keflin IV half an hour before surgery, and after surgery cephalexin 500 mg P.O. every 6 hours for 48 hours with 250 mg azithromycin P.O. every 12 hours was prescribed for them.
Category
Treatment - Drugs
2
Description
This prospective , randomized study of 231 pregnant women undergoing elective cesarean section from Mordad 1391 Persian date to Mordad 1392 from Bandar Abbas, Shariati Hospital was performed. Control group received 2 g IV Keflin half hour before surgery for antibiotic prophylaxis and 48 hours after C/S, 500 mg every 6 hours cephalexin placebo and 250 mg azithromycin placebo was administered PO every 12 hours for them .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariati Hos.
Full name of responsible person
Dr. Maryam Abbasian
Street address
ُِDr Shariati Hos., Shahid Naser Ave., Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DR Maryam Azizi
Full name of responsible person
Maryam Abbasian
Street address
DR Shariati Hos., Shahid Naser Ave., Bandar Abbas
City
Bandar Abbas
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DR Maryam Azizi
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Maryam Abbasian
Position
GYN Resident
Other areas of specialty/work
Street address
Dr. Shariati Hos., Shahid Naser Ave., Bandar Abbas