In this study we investigate and compare the effect of Aloe Vera gel and sweet almond oil, which had been traditionally used, on striae gravidarum. In this double blind clinical trial 160 nulliparous women enroll and randomly divide into 3 intervention groups and I control group. The first, the second and the third groups respectively will be given 700g Aloe Vera cream, sweet almond oil cream and base cream to use topically on the abdominal skin. Inclusion criteria: 20-35-years-old nulliparous women with normal body mass index (18.5-26); informed consent for participation in the study; using no topical medication for the treatment or prevention of striae before entering the study; and having no skin diseases. Exclusion criteria: twin pregnancy; Polyhydramnios; preterm labor; the subject’s unwillingness to participate in the study; early termination of the cream; below 2 kg or above 4 kg infant birth weight; and using creams other than one prescribed for the study.
Then, within six stages, they will be examined in terms of the study’s variables (itching and erythema and spread and diameter of striae).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110827998N4
Registration date:2016-12-11, 1395/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-11, 1395/09/21
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shahrekord University of Medical Sciences
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2013-06-30, 1392/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Aloe Vera gel and Sweet Almond oil on Striae Gravidarum in nulliparous women
Public title
Comparison the effect of Aloe Vera gel and Sweet Almond oil on Striae Gravidarum in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20 to 35 years old nulliparous women with normal body mass index (18.5 to 26); informed consent for participation in the study; using no topical medication for the treatment or prevention of striae before entering the study; and having no skin diseases.
Exclusion criteria: twin pregnancy; Polyhydramnios; preterm labor; the subject’s unwillingness to participate in the study; early termination of the cream; below 2 kg or above 4 kg infant birth weight; and using creams other than one prescribed for the study.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research of Shahrekord University of Medical Sciences
Street address
Billding number 2, university complex, Edarat avenue, Shahrekord
City
Shahrekord
Postal code
Approval date
2011-08-07, 1390/05/16
Ethics committee reference number
12-5-90
Health conditions studied
1
Description of health condition studied
steria gravidarum
ICD-10 code
026.8
ICD-10 code description
Other specified pregnancy-related conditions
Primary outcomes
1
Description
the number of abdominal areas affected by striae ,
Timepoint
during a six months period and in monthly
Method of measurement
the number of abdominal areas affected by striae (abdomen division into four zones) was measured by the examiner based on counting the number of areas
2
Description
number of striae
Timepoint
during a six months period and in monthly
Method of measurement
the number of striae was measured based on the observer’s observations
Secondary outcomes
1
Description
itching
Timepoint
during a six months period and in monthly
Method of measurement
itching (qualitative measure: low, medium, high) based on the subject’s expression
2
Description
Striae diameter ,
Timepoint
during a six months period and in monthly
Method of measurement
by calipers
3
Description
erythema
Timepoint
during a six months period and in monthly
Method of measurement
qualitative measure: low, medium, high) by the observer’s observation
Intervention groups
1
Description
Intervention group 1 : Will be given 700 g combination of aloe Vera (extracted from aloe Vera leaves) in a cream base and in a 1 to 1 ratio to rub 2g every 12 hours gently and without massage on the abdominal skin from the 16th week of pregnancy until the delivery day. The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26).
Category
Treatment - Drugs
2
Description
Intervention group 2 : Each subject will be given 700 g combination of sweet almond oil in a cream base to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day. The amount of cream will be calculated based on the Finger Tip Unit (FTU) (26).
Category
Treatment - Drugs
3
Description
Control group 1 :They will only be given 700g base cream to rub 2g every 12 hours gently and without massage on all abdominal area from the 16th week of pregnancy until the delivery day.
Category
Placebo
4
Description
Control group 2 : They will be received no medication to treat or prevent striae.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Share-kord Imam Ali Gynecological clinic
Full name of responsible person
Dr Shadi Memarian
Street address
Imam Ali Gynecological clinic, Parastar avenue, Shahre-Kord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of ShahreKord University of Medical Sciences
Full name of responsible person
Dr Seyed Kamal Solati
Street address
Bilding number 2, University Setad, Ayatolah Kashani avenue, ShahreKord
City
ShahreKord
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 of ShahreKord University of Medical Sciences