In this randomized clinical trial 526 women undergoing cesarean delivery in university hospital in Mashhad (Iran) will be evaluated. Participants including 526 women undergoing cesarean delivery and nit having: preterm pregnancy, (GA<37), placenta previa, severe anemia (Hct<30), chorio aminoitis, Meconium Amniotic Fluid, Obesity (weight more than>114Kg), Multi fetal gestation, arrest in descending in station ≥0 and prolonged premature rupture of membranes (>18h). Intervention: subjects will receive either standard abdominal scrub alone or abdominal scrub with an additional vaginal preparation with povidone –iodine solution. All subjects receives prophylactic antibiotic after clamping the cord. Main Outcome measures (variables) are: each subject’s postoperative course was reviewed for development of endometritis (fever and uterine tenderness after exclusion of other causes).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105146467N1
Registration date:2011-06-18, 1390/03/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Nayereh Ghomian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2631
Email address
ghomiann@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-01-01, 1386/10/11
Expected recruitment end date
2009-01-01, 1387/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preoperative vaginal preparation with Povidone –Iodinand the risk of post cesarean Endometritis
Public title
Relationship between vaginal preparation with Povidone –Iodinand and Endometritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women who are candidate for cesarean section
Exclusion criteria:
Preterm pregnancy; gestational age<37 weeks; placenta previa; severe anemia (Hct<30); chorioaminoitis; diabetes mellitus; Meconium Amniotic Fluid; Obesity (weight>114Kg); Multifetal gestation; prolonged induction(>10hours); arrest in descending in station ≥0 and prolonged premature rupture of membranes(>18hours)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
526
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
Faculty of Medicine
Street address
Vakil abad blv.
City
Mashhad
Postal code
Approval date
2007-04-22, 1386/02/02
Ethics committee reference number
2036-T
Health conditions studied
1
Description of health condition studied
Endometritis
ICD-10 code
n71.9
ICD-10 code description
Inflamatory disease of uterus except cervix
Primary outcomes
1
Description
Body temperature
Timepoint
Daily
Method of measurement
Thermometer
Secondary outcomes
1
Description
Endometritis
Timepoint
Daily
Method of measurement
Fever and uterine tenderness after exclusion of other causes
Intervention groups
1
Description
Intervention group: vaginal irrigation with povidone-iodine plus abdominal irrigation plus 2 gr cefazoline IV after clamping the cord
Category
Treatment - Drugs
2
Description
Control group: abdominal irrigation with povidone-iodine plus 2 gr cefazoline IV after clamping the cord
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza and Omolbanin hospitals
Full name of responsible person
Dr.Nayereh Ghomian
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashahad University of Medical Sciences
Full name of responsible person
Dr. Jalil Tavakol Afshari
Street address
Ghoreyshi
City
Mashhad
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, Mashahad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nayereh Ghomian
Position
Associated Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2608
Fax
Email
Ghomiann@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nayerh Ghomian
Position
Gynecologist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2608
Fax
Email
ghomiann@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Nayereh Ghomian
Position
Associated Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2608
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)