Because cesarean section is one of the most prevalent surgeries in women, so reduction of complications and time of operation and finding the simpler techniques with least complications has special importance .We compared the early results (time of operation, pain, fever and wound infection) in two groups of patients for whom the visceral peritoneum was either repaired or left alone. The purpose was to suggest the best method with least complications after cesarean section. In a comparative experimental research 258 pregnant women that had cesarean section for the first time was recruited into this study. Time of operation, pain, fever and the rate of wound infection were compared in the two groups. For statistical analysis, we used Z test and chi square.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903274198N1
Registration date:2007-04-03, 1386/01/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2007-04-03, 1386/01/14
Registrant information
Name
Fariba Almassi Nokiani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 5332
Email address
dralmassi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2007-04-03, 1386/01/14
Expected recruitment end date
2008-04-02, 1387/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of early results of closure and non closure of visceral peritoneum in cesarean section
Public title
Comparison of early results of closure and non closure of visceral peritoneum in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
1- First elective cesarean section before starting of labor
2- BMI<25
3- No diabetes, hypertension and rupture of membranes
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
258
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Kermanshah university of medical sciences
Street address
Shahid Beheshti Boulevard
City
Kermanshah- Kermanshah university of medical sciences - Shahid Beheshti Bol
Postal code
Approval date
empty
Ethics committee reference number
88017
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy
Primary outcomes
1
Description
Fever
Timepoint
Every 6 hours in the first week after operation
Method of measurement
Sublingual temometer
2
Description
Pain
Timepoint
First 48 hours after operation
Method of measurement
The number of Indomethacin suppositories
3
Description
Nausea
Timepoint
Each 12 hours within the first 24 hours after cesarean section
Method of measurement
Visit by resident
Secondary outcomes
empty
Intervention groups
1
Description
Closure of visceral peritoneum in elective cesarean section
Category
Treatment - Surgery
2
Description
Non-closure of visceral peritoneum in elective cesarean section
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Fariba Almassi Nokiani
Street address
Ferdowsi Square, Motazedi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Scinces
Full name of responsible person
Fariba Almassi Nokiani
Street address
Ferdowsi Square, Motazedi Hospital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Scinces
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
Kermanshah University of Medical Sciences
Full name of responsible person
Fariba Almassi Nokiani
Position
Gynecologist, Associate Professor, Iran University of Medical Sciences
Other areas of specialty/work
Street address
Ferdowsi Square, Motazedi Hospital
City
Kermanshah
Postal code
Phone
00988317246639; 009883188723150
Fax
+98 21 8871 5216
Email
dralmassi@iums.ac.ir; dralmassi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fariba Almassi Nokiani
Position
Gynecologist, Associate Professor, Iran University of Medical Sciences
Other areas of specialty/work
Street address
Ferdowsi Square, Motazedi Hospital
City
Kermanshah
Postal code
Phone
00988317246639; 009883188723150
Fax
+98 21 8871 5216
Email
dralmassi@iums.ac.ir; istatis_pn@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Pegah Nafar
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
istatis_pn@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)