Purpose : This study aims to determine the effect of Prineal massage in pregnancy women on the rate of Perineal episiotomy rupture and a single-blinded has been done randomly .
The survey population : It involved all of the pregnant women waiting for a normal labor referred to the clinics for examination .
Entry and exit criteria : The age of a 36- weeks conception or more was Nulliparos . Doing Kegel´s exercises or the other exercises as professional and the lack of mother´s cooperation during the study were regarded as the exit criteria .l
Sample size : 100 pregnant women were selected using simple sampling and placed into two 50 – person groups of intervention and control .
Intervention : Perineal massage was initiated from 36 weeks of conception . 50 pregnant women referred to the clinics daily and Perineal massage done for them with a softer solution in water like coconut or olive oils for 3 – 10 min a day by expert midwives .
Time : Perineal massage was done daily during 30 days .
Initial outcome :At the end , the need to Perineal episiotory and the rate of its rupture were compared in two groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202288069N2
Registration date:2012-03-19, 1390/12/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-19, 1390/12/29
Registrant information
Name
Fatemeh Salmani
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1581 2914
Email address
f-salmani@iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-05-28, 1391/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Perineal Massage in pregnancy period on the rate of Perineal episiotomy and rupture
Public title
The effect of Perineal Massage on the Perineal rupture
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criteria : The age of a 36- weeks conception or more was Nulliparos.
exit criteria :Doing Kegel´s exercises or the other exercises as professional and the lack of mother´s cooperation during the study were regarded as the exit criteria .
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Islamic Azad Universityof Najaf abad Branch
Street address
Islamic Azad Universityof Najaf abad Branch, Najaf abad
City
Esfahan
Postal code
517
Approval date
2010-09-10, 1389/06/19
Ethics committee reference number
51501851101002
Health conditions studied
1
Description of health condition studied
pregnancy & delivery
ICD-10 code
o90
ICD-10 code description
Complications of the puerperium, not elsewhere classified
Primary outcomes
1
Description
No episiotomy & perineal lacerations
Timepoint
delivery on time
Method of measurement
abservation & questioneir
Secondary outcomes
1
Description
Pain and vaginal bleeding
Timepoint
Postpartum of daily
Method of measurement
Observation and Examination
Intervention groups
1
Description
50 pregnant women referred to the clinics daily and Perineal massage done for them with a softer solution in water like coconut or olive oils for 3 – 10 min a day by expert midwives .
Category
Prevention
2
Description
Control group: no effort was made to them.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Azam Foroghipour
Street address
Shariati hospital, Shariati Street
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Najafabab
Full name of responsible person
Dr Reza Ebrahimi(Research Assistant)
Street address
Islamic Azad University of Najaf abab Branch, University Street, Najaf bad
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Najafabab
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
Islamic Azad University of Najaf abad Branch
Full name of responsible person
Azam Foroghipour
Position
Master of midwifery
Other areas of specialty/work
Street address
Midwifery group,Islamic Azad University of Najaf abad Branch, Najaf abad
City
Esfahan
Postal code
517
Phone
+98 33 1229 1111
Fax
Email
azamforoghipour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Najaf abad Branch
Full name of responsible person
Azam Foroghipour
Position
Master of midwifery
Other areas of specialty/work
Street address
Midwifery group, Islamic Azad University of Najaf abad Branch
City
Esfahan
Postal code
517
Phone
+98 33 1229 1111
Fax
Email
azamforoghipour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Najaf abad Branch
Full name of responsible person
Fatemeh Salmani
Position
Master of nursing
Other areas of specialty/work
Street address
Nursing group, Islamic Azad University of Najaf abad Branch, Najaf abad
City
Esfahan
Postal code
8199855781
Phone
+98 33 1229 1111
Fax
Email
f-salmani@iaun.ac.ir ft_salmani@yahoo.com.au
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)