The Effect of sesame oil , sweet almond oil and combination of the both of sesame oil _ sweet almond oil on prevention of striae gravidarum in nulliparous women:A randomized controlled clinical trial
Objectives: This study aims to determine the Effect of sesame oil, sweet almond oil and combination of the both of sesame oil _ sweet almond oil on prevention of striae gravidarum in nulliparous women. Design: Triple blind Randomized Controlled Trial. Setting and conduct: This study will be conducted in arak health centers. Eligible women will be selected with convenience sampling and will be randomly assigned into 4 groups of 50 subjects with block sizes of 4 and 8. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Participants: 200 nulliparous women aged 18 to 35 years with gestational age of 16 to 20 weeks who have not any striae on the abdomen, thighs, arms and breasts and don’t using any other herbal or chemical drugs on their abdomen. Interventions: After completing the basic information, one intervention group will receive sesame oil (1cc, twice a day) and second intervention group will receive sweet almond oil (1 cc, twice a day).Third group will receive the combination of sesame oil and sweet almond oil (1 cc, twice a day). The control group will receive placebo. Main outcome measures: Incidence and severity of striae will be evaluated by the Davey method and incidence and severity of irritation will be evaluated by Kamini method at the end of the intervention. Secondary outcomes include the comparison of side events of the oils among the intervention groups that will be evaluated by the checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208048170N3
Registration date:2013-09-22, 1392/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of sesame oil , sweet almond oil and combination of the both of sesame oil _ sweet almond oil on prevention of striae gravidarum in nulliparous women:A randomized controlled clinical trial
Public title
The Effect of sesame oil , sweet almond oil and combination of the both of sesame oil _ sweet almond oil on prevention of striae gravidarum in nulliparous women:A randomized controlled clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
1.Pregnant women with gestational age of 25-30 weeks aged 18 to 35 years old; pregnant women Age group between 18-35,2. Being nulliparous, 3.Having a single aliving fetous, 4. Gestational age 16-20 weeks (according last mensturation period or sonography ),5.Body mass index between 19.8-25, 6.Not having known coronic diseases such as adrenal disorders and diabetes (according woman telling ), 6. being literate, 7.Not using an other herbal or chemical drugs during pregnancy, 8. Not having any estriae on the abdomen ,arms,thighs and breasts 9.Being able to use the oils twice aday 10.Not going on any special diet. exclusion criteria :1.Having known skin diseases;2.polyhydraminious pregnancy;3.having allergy history to studied drugs;4.Having past surgical history on the abdomen;5.Having any malegnancy on the abdomen
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
00984113357311
Approval date
2013-08-11, 1392/05/20
Ethics committee reference number
9290
Health conditions studied
1
Description of health condition studied
Striae gravidarum
ICD-10 code
026.9
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
The incidence of estriae
Timepoint
At the end of the intervention
Method of measurement
The vising by educated midwives
2
Description
Severity of the estriae
Timepoint
At the end of the intervention
Method of measurement
Davey method
3
Description
The incidence of the irritation
Timepoint
At the end of the intervention
Method of measurement
Kamini method
4
Description
The severity of the irritation
Timepoint
At the end of the intervention
Method of measurement
Kamini method
Secondary outcomes
1
Description
The comparision of the side events of the oils among intervention groups
Timepoint
At the end of the intervention
Method of measurement
The checklist
Intervention groups
1
Description
The first intervention group will recieved 1 cc sesame oil twice a day during 20 weeks
Category
Prevention
2
Description
The second intervention group will received 1 cc sweet almond oil ,twice a day during 20 weeks
Category
Prevention
3
Description
The third intervention group will received 1 cc the combination of sweet almond oil and sesame oil ,twice a day during 20 weeks
Category
Prevention
4
Description
The control group will received 1 cc placebo oil ,twice a day during 20 weeks.The placebo oil incudes distilled water and lubricant jel
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak health centers
Full name of responsible person
Kamrani Atefeh
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Kamrani Atefeh
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 86 3224 3459
Fax
Email
atykamrani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti Jamileh
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
malakoutij@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti Jamileh
Position
MSC in midwifery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
malakoutij@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)