We are going to investigate the effect of preoperative vaginal preparation with povidone-Iodine as a preventive intervention against post cesarean endometritis and wound infection. The main inclusion criteria is undergoing non emergent cesarean delivery and exclusion criteria are history of sensitivity to betadine, chorio amnionitis, Active genital Herpes during pregnancy, and emergency cesarean section . 568 patients will be enrolled in this study. After signing informed written consent, each patient will be assigned to receive standard abdominal skin preparation with Povidone-Iodine or the standard abdominal preparation plus an additional 30 seconds vaginal scrub with Povidone-Iodine solution. All patients will receive a single dose of parental antibiotic prophylaxis with 1 gram cefazolin half an hour before operation and then for 24 hours. Only in intervention group vaginal preparation will be performed with sponge sticks saturated with povidone iodine solution. After discharging from hospital and complete a 6 week puerperal period their chart will be reviewed by physician for development of postoperative febrile morbidity, diagnosis of endometritis, and or wound infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706201233N1
Registration date:2009-02-09, 1387/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-02-09, 1387/11/21
Registrant information
Name
Maryam Asgharnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
asgharnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice-chancellorship, Guilan University of Medical Science
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative vaginal povidone Iodine preparation on post cesarean infection
Public title
The effect of preoperative vaginal povidone Iodine preparation on post cesarean infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being candidate for non emergent cesarean delivery.
Exclusion criteria: history of sensitivity to betadine, chorio amnionitis, Active genital Herpes during pregnancy , any purulent discharge with pruritus or dysuria or malodor discharge during pregnancy, emergency cesarean section, fetal distress, vaginal bleeding due to placenta previa or placental abruption, no time for vaginal preparation.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
284
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan university of medical science
Street address
namjo.street. Research vice chancellorship-Guilan university medical science
City
rasht
Postal code
Approval date
2008-06-07, 1387/03/18
Ethics committee reference number
2007/132/3/پ
Health conditions studied
1
Description of health condition studied
Post-cesarean infection
ICD-10 code
O86
ICD-10 code description
Other puerperal infections
Primary outcomes
1
Description
Incidence of Fever
Timepoint
Before Cesarean section, and at the end of week 1 , 2, 3 , 4, 5, and 6 after operation
Method of measurement
Temperature>38 degree centigrade by oral thermometer
2
Description
Uterine fundal tenderness
Timepoint
Before intervention,one month and after intervention 6 monthes
Method of measurement
Uterine palpation (Physical examination)
3
Description
Incidence of wound infection
Timepoint
Before intervention,one month and after intervention 6 monthes
Method of measurement
Purulent discharge, pruritus
Secondary outcomes
1
Description
Incidence of endometritis
Timepoint
Before Cesarean section, and at the end of week 1 , 2, 3 , 4, 5, and 6 after operation
Method of measurement
Physical examination
Intervention groups
1
Description
One gr parenteral cephazoline half an hour before operation
Category
Prevention
2
Description
vaginal scrub with povidone-Iodine solution plus 1 gr parenteral cephazoline half an hour before operation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra treatment and educated center
Full name of responsible person
Maryam Asgharnia
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research department
Full name of responsible person
Dr Sobhani
Street address
Medical University, Namjo st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research department
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
Guilan University of Medical Science, Rasht, Iran
Full name of responsible person
Maryam Asgharnia
Position
Associate professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Al-Zahra hospital, Namjo st.
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
+98 13 1322 8724
Email
Asgharnia@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Health Research Centre
Full name of responsible person
Maryam Asgharnia
Position
Associated professor Guilan university of medical science
Other areas of specialty/work
Street address
Reproductive Health Research Centre, Al-Zahra hospital. Namjo st.
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Asgharnia@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Centre, Al-Zahra Hospital
Full name of responsible person
Seyede Fatemeh Dalil Hirati
Position
Obsterician
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 13 1322 5624
Fax
Email
fatemehdalil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)