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Comparison of the effect of sesame oil and almond oil on preventing the striae gravidarum

Protocol summary

Study aim
Determination comparison of the effect of sesame oil and almond oil on preventing the striae gravidarum.
Design
A randomized clinical trial, with parallel group and blinded, design of 134 patients, enrolled between July 2014 and February 2018, and Followed up to 20 weeks for each pregnant women.
Settings and conduct
Double blinded sampling was done in public health centers in the north, south, east, west and downtown in Kashan. The samples were randomly divided into sesame oil, almond oil and control groups. The intervention groups use oils and the control group did not use any substance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The current gestational age is 16 weeks, no history of abortion at gestational age 16 weeks or more, singleton pregnancy, being Iranian, nulliparous Exclusion criteria: use of other substances for the prevention or treatment of striae, presence of striae, having Cushing's disease and diabetes, alcoholic, BMI >30
Intervention groups
The sesame oil group: The participants rubbed 1cc of sesame oil 2 times daily on their abdomen and massaged it for 5 minutes during 20 weeks from 16 to 36 weeks of gestation. The almond group: The participants rubbed 1cc of sweet almond oil 2 times daily on their abdomen and massaged it for 5 minutes during 20 weeks from 16 to 36 weeks of gestation. The control group: The participants in this group did not use any substance or drug to prevent of striae gravidarum from 16 to 36 weeks of gestation.
Main outcome variables
The incidence of striae gravidarum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091111002699N6
Registration date: 2018-07-06, 1397/04/15
Registration timing: retrospective

Last update: 2018-07-06, 1397/04/15
Update count: 0
Registration date
2018-07-06, 1397/04/15
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
Expected recruitment start date
2014-07-06, 1393/04/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2014-07-11, 1393/04/20
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Comparison of the effect of sesame oil and almond oil on preventing the striae gravidarum
Public title
Effect of sesame oil and almond oil on the striae gravidarum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The current gestational age is 16 weeks no history of abortion at gestational age 16 weeks or more singleton pregnancy being Iranian being nulliparous
Exclusion criteria:
use of other substances for the prevention or treatment of striae presence of striae having Cushing's disease having diabetes use of alcohol BMI >30
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 150
Actual sample size reached: 134
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization using random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Almond oil and sesame oil were prepared in completely similar glasses, and the research associate were unaware of the oil type.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th of Qotb –e Ravandi Blvd., Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
1507/1/5/29/پ

Health conditions studied

1

Description of health condition studied
striae gravidarum
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Incidence of striae gravidarum
Timepoint
Weeks 16, 20, 24, 28, 32 and 36 gestation
Method of measurement
Davey's score

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group, Almond oil user group: The participants in this group rubbed 1cc of sesame produced by Barij Essence Pharmaceutical Co. oil 2 times daily on their abdomen and massaged it for 5 minutes during 20 weeks from 16 to 36 weeks of gestation.
Category
Prevention

2

Description
Intervention group: Sesame oil user group Group:The participants in this group rubbed 1cc of sweet almond oil produced by Barij Essence Pharmaceutical Co. 2 times daily on their abdomen and massaged it for 5 minutes during 20 weeks from 16 to 36 weeks of gestation.
Category
Prevention

3

Description
Control group: The participants in this group did not use any substance or drug to prevent of striae gravidarum from 16 to 36 weeks of gestation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Farzaneh Saberi
Street address
5th of Qotb –e Ravandi Blvd, Faculty of Nursing & Midwifery, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
saberi_f@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi (Ph.D)
Street address
5th of Qotb –e Ravandi Blvd., Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
hamidi_gh@kaums.ac.ir
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
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
Kashan University of Medical Sciences
Full name of responsible person
Farzaneh Saberi
Position
Associate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5th of Qotb –e Ravandi Blvd., Fazaneh saberi, Faculty of Nursing & Midwifery, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
saberi_f@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Farzaneh Saberi
Position
Associate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5th of Qotb –e Ravandi Blvd.,Farzaneh Saberi, Faculty of Nursing & Midwifery, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
saberi_f@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Farzaneh Saberi
Position
Associate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
5th of Qotb –e Ravandi Blvd., Farzaneh Saberi, Faculty of Nursing & Midwifery, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
saberi_f@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Total data is Sharable after unidentifiable people.
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-based companies can take data from this study.
Under which criteria data/document could be used
Researchers working in college or industry-based companies can use the results after getting permission from the authors of the study.
From where data/document is obtainable
5th of Qotb –e Ravandi Blvd.,Farzaneh Saberi, Faculty of Nursing & Midwifery, Kashan, IRAN P.O.Box: 8715981151 E-mail: saberi_f@kayms.ac.ir
What processes are involved for a request to access data/document
Two weeks after receiving a request
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