This study was carried out to compare the length of perineal laceration in primiparous women with and without episiotomy referred to Shabikhani hospital in Kashan in 2006-2007. This clinical trial study carried out on 180 primiparous women at term and single fetus with cephalic presentation and estimated fetal weight of 2500-3500 grams. The participants were assigned randomly and equally into intervention and control groups. Delivery carried out without episiotomy in intervention group but with episiotomy in control group. The length of posterior perineal laceration, anterior perineal laceration and need for repair were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809182699N2
Registration date:2010-03-06, 1388/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-06, 1388/12/15
Registrant information
Name
Farzaneh Saberi
Name of organization / entity
Kashan University Of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
saberi_f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Kashan University of Medical Sciences
Expected recruitment start date
2006-11-11, 1385/08/20
Expected recruitment end date
2007-08-21, 1386/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the length of perineal laceration in primiparous women with and without episiotomy, Shabikhani hospital in Kashan
Public title
Comparison of the length of perineal laceration in primiparous women with and without episiotomy, Shabikhani hospital in Kashan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: primiparous, term pregnancy, single fetus, cephalic presentation, estimated fetal weight of 2500-3500 grams.
Excluding criteria: multiple pregnancy, forceps and vacuum delivery, estimated fetal weight lower than 2500 or upper than 3500 gram, preterm labor, fetal malpresentation, occiput posterior position, precipitated labor and all complications that need to decrease length of second stage of labor (such as fetal distress, hemorrhage …)
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Kashan University Of Medical Sciences
Street address
Kashan University Of Medical Siences, Ghotb-e-Ravandi Blvd.,
City
Kashan
Postal code
8715981151
Approval date
empty
Ethics committee reference number
3260/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Delivery with episiotomy
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Length of perineal laceration
Timepoint
Immediatley post partum
Method of measurement
Standard ruler
Secondary outcomes
1
Description
post partum hemorrhage
Timepoint
During first hour after delivery
Method of measurement
Observation
Intervention groups
1
Description
Episiotomy
Category
Prevention
2
Description
no episiotomy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Science
Full name of responsible person
Dr. Mansoureh Samimi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Vice Chancellor for Research, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Farzaneh Saberi
Position
MS. Facuity Member
Other areas of specialty/work
Street address
Nursing-Midwifery Faculty. Kashan University of Medical Science.
City
Kashan
Postal code
Phone
+98 36155500215
Fax
+98 36 1555 6633
Email
saberi_f2002@yahoo.com saberi_f@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mansoureh Samimi
Position
Gynecologist
Other areas of specialty/work
Street address
Medical Faculty, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
Dr_samimi2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)