According to prevalence and complication of post cesarean infection, this study is done to determine the effectiveness of preoperative vaginal preparation an antiseptic solution to reduce post caesarean infectious morbidity and endometritis.
This randomized clinical trial study is conducted on 400 patients referred to Rouhani hospital for elective cesarean section since 2013 to 2014. For case group, the vaginal washing before stomach washing is performed with two gauzes impregnated with povidone iodine 10%. Each gauze is rotated 360-degree in all parts of the vagina, especially in the fornixes, so that the washing process lasted 30 seconds. In both groups, the abdomen washing is done with povidone iodine 10% and 3 gauzes. The total duration of belly washing last for five minutes. The control group is only received the abdomen wash with povidone iodine. In all patients after clamping the umbilical cord, 2 g of intravenous Cefazolin is injected. All of Patients after 24 hours after surgery giving antibiotic. Information on the second 24 hours after surgery for the fever, uterine tenderness, foul-smelling and tachycardia is done. One week after discharge and after 6 weeks again they were examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061425292N6
Registration date:2016-06-27, 1395/04/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Sedigheh Smaeilzadeh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
crdu.rohan@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor research , Babol university of medical science
Expected recruitment start date
2014-03-31, 1393/01/11
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal preparation with povidone iodine on post cesarean infection in women admitted to hospital
Public title
vaginal preparation with povidone iodine on post cesarean infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective cesarean section; Singleton pregnancy: Term pregnancy. Exclusion criteria: Patients with severe anemia (hematocrit less than 30%); Diabetes; Recent use of antibiotics or cortisones; Twins or more pregnancy; Morbid obesity (over 114 kg); Along with premature rupture of membrane; Labor induction; Amniotic fluid bloody and meconial intraoperative.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Ethics Committee of Babol university of medical science
24 hours after surgery, After 1 week, After 6 weeks
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The vaginal washing before stomach washing is performed with two gauzes impregnated with povidone iodine 10%. Each gauze is rotated 360-degree in all parts of the vagina, especially in the fornixes, so that the washing process lasted 30 seconds and the abdomen washing is done with povidone iodine 10% and 3 gauzes .
Category
Prevention
2
Description
Control group: Only the abdomen washing is done with povidone iodine 10% and 3 gauzes .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani hospital
Full name of responsible person
Zeinab Zabihi
Street address
Ganjafrouz- Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Babol university of medical science
Full name of responsible person
Mahmoud Babaie
Street address
Ganj Afrouz Street
City
Babol
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 of Babol university of medical science
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
Babol university of medical science
Full name of responsible person
Zeinab Zabihi
Position
MD
Other areas of specialty/work
Street address
Ganj Afrouz Street
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
mojy_rad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol university of medical science
Full name of responsible person
Azita Ghanbarpour
Position
Obstetrician and gynecologist
Other areas of specialty/work
Street address
Ganj Afrouz Street
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
dr_ghanpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical science
Full name of responsible person
Zeinab Zabihi
Position
MD
Other areas of specialty/work
Street address
Iran-Ganj Afrouz Street-Babol university of medical science
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
mojy_rad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)