Perineal massage Effect on the incidence of episiotomy
Design
in this randomized control trial 100 pregnant women between 18 and 35 years
first pregnancy and gestation age between 37 and 42 weeks will enrolled. patients will be accidentally divided into two groups. In intervention group investigator will wear a glove with lubricant and inserting her fingers 2-3 cm into the vagina and compress the vaginal wall for 2 minutes. At least each patient will receive four massage and will rest 30 minutes between massages. control group will receive routine care during labor.
Settings and conduct
This study will be conducted under the supervision of Mashhad university of medical sciences in Omol Banin hospital. Physician who will perform the delivery will unaware of intervention.
Participants/Inclusion and exclusion criteria
pregnant women aged between 18 and 35 with gestational age between 37 and 41 weeks will enrolled the study.
Intervention groups
Investigator will wear a glove with lubricant and inserting her fingers 2-3 cm into the vagina and compress the vaginal wall for 2 minutes.
Main outcome variables
The incidence of episiotomy and laceration will be compered between groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100307003497N2
Registration date:2018-04-16, 1397/01/27
Registration timing:prospective
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
0511-2231444
Email address
akhlaghif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-03-03, 1397/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of perineal massage on the rate of episiotomy in primiparous women
Public title
Effect of perineal massage on the rate of episiotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women between 18 and 35 years
first pregnancy
gestation age between 37 and 42 weeks
first phase of delivery
Exclusion criteria:
high risk pregnancy
underlying disease (HTN, DM, etc)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
patients will divided based on randomization table into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Physician who will performed the labor will be unaware about the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Approval date
2017-09-21, 1396/06/30
Ethics committee reference number
IR.MUMS.fm.REC.1396.186
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
O09.219
ICD-10 code description
Supervision of pregnancy with history of pre-term labor, unspecified trimester
Primary outcomes
1
Description
episiotomy and laceration
Timepoint
During labor
Method of measurement
Perineal examination
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group investigator will wear a glove with lubricant and inserting her fingers 2-3 cm into the vagina and compress the vaginal wall for 2 minutes. At least each patient will receive four massage and will rest 30 minutes between massages.
Category
Prevention
2
Description
Control group: control group will receive routine care during labor.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Farideh Akhlaghi
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3852 5312
Email
akhlaghif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3762 3320
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farideh Akhlaghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Imam Reza Square, Ebne Sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3852 5312
Email
akhlaghif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farideh Akhlaghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3852 5312
Email
akhlaghif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farideh Akhlaghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3852 5312
Email
akhlaghif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available