Evaluation of the effect of vaginal and perineal massage with sesame oil on labor in primiparous women
Design
A single blind randomized clinical trial with parallel group design, consisted of 180 patients, enrorolled between January 2019 and April 2020.
Settings and conduct
This single blind study will be done at Razi and Sina hospitals in Ahvaz. The samples will be randomly divided into sesame oil, gel and the control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous women; fetal age between 37-42 weeks based on ultrasound and LMP; approximate fetal weight between 2500 to 4000 gr; fetal cephalic presentation; maternal age between 18-35 years; written consent to participate in the study. Non-inclusion criteria: chronic maternal disease; high risk pregnancy; body mass index (BMI) > 30.
Intervention groups
Intervention group 1 (Sesame Oil): the vagina and perineum of the participants in this group are massaged by 1 cc of oil for 3 minutes in each vaginal examination in the second stage of labor. Intervention group 2 (gel): the vagina and perineum of participants in this group are massaged by 1cc of gel for 3 minutes in the second stage of labor in each vaginal examination. Control group: the participants in this group receive no intervention in the second stage of labor.
Main outcome variables
Need to episiotomy; perineal laceration; length of second stage of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170422033583N1
Registration date:2020-03-21, 1399/01/02
Registration timing:registered_while_recruiting
Last update:2020-03-21, 1399/01/02
Update count:0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 4184
Email address
shushtaripour.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of vaginal and perineal massage with sesame oil compared to gel on labor in primiparous women
Public title
The effect of vaginal and perineal massage with sesame oil on labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
Gastational age between 37 to 42 weeks based on ultrasound and LMP
Approximate fetal weight between 2500 and 4000 gr
Single live fetus
Cephalic presentation
Maternal age between 18 to 35 years
Written consent to participate in the study
Exclusion criteria:
Chronic illness in the mother
Emergency cesarean section following fetal distress, placenta abruption, cord prolapse or intrauterine growth retardation
Precipitate labor
body mass index (BMI) > 30
High risk pregnancy
Need to do induction
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
Sesame oil and gel will be prepared in completely similar glasses and the participants will be unaware of the content of glasses.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
No23; before Zand intersection; between Katanbaf and Basangeideh; Shahid Masjedi street
City
Ahvaz
Province
Khouzestan
Postal code
6195774589
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.AJUMS.REC.1398.693
Health conditions studied
1
Description of health condition studied
Reduce episiotomy and perineal laceration
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Reduce the length of the second stage of labor
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Need for episiotomy
Timepoint
After the intervention
Method of measurement
partograph chart and labor progress record
2
Description
Perinael laceration
Timepoint
After the intervention
Method of measurement
partograph chart and labor progress record
3
Description
Length of second stage of labor
Timepoint
After the intervention
Method of measurement
partograph chart and labor progress record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (Sesame Oil): the vagina and perineum of the participants in this group are massaged by 1 cc of Sesame oil for 3 minutes in each vaginal examination in the second stage of labor.
Category
Prevention
2
Description
Intervention group 2 (gel): the vagina and perineum of participants in this group are massaged by 1cc of gel for 3 minutes in each vaginal examination, in the second stage of labor.
Category
Prevention
3
Description
Control group: the participants in this group receive no intervention in the second stage of labor.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Mojgan Javadnoori
Street address
Phelestine street; Amanyeh
City
Ahvaz
Province
Khouzestan
Postal code
6195774589
Phone
+98 61 3333 3050
Email
fatshush@gmail.com
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mojgan Javadnoori
Street address
Gandomkar 5 street; Imam Ali square; Kootabdolah
City
Ahvaz
Province
Khouzestan
Postal code
6195774589
Phone
+98 61 3555 0592
Email
fatshush@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Muhammad Badavi
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8333
Email
fatshush@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Second Floor; Ahvaz School of Nursing and Midwifery; Shahre Daneshgahi; Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613367543
Email
javadnoori-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Second Floor; Ahvaz School of Nursing and Midwifery; Shahre Daneshgahi; Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613367543
Email
javadnoori-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Second Floor; Ahvaz School of Nursing and Midwifery; Shahre Daneshgahi; Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613367543
Email
javadnoori-m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Total data is Shared after making people unidentifiable.
When the data will become available and for how long
Start the access period: 6 months after printing the results.
To whom data/document is available
Researchers working in college or industry-base companies can take data of this study.
Under which criteria data/document could be used
Researchers working incollege or industry -based companies can use the results after getting permission from the authors of the study.
From where data/document is obtainable
Second Floor; Ahvaz School of Nursing and Midwifery; Shahre Daneshgahi; Golestan Road, IRAN.P.BOX:6135715794. E-mail:javadnoori-m@ajums.ac.ir
What processes are involved for a request to access data/document