the effect of aloe vera gel on strea gravidarum prevention
Design
Clinical trial of three blinded with a control group with a random assignment on 90 nullipar women
Settings and conduct
In 1398, 90 women referred to two health centers affiliated with Shahid Beheshti University underwent surgery
Participants/Inclusion and exclusion criteria
Nulliparus
Single pregnancy
Intervention groups
Group a received placebo
Group b received aloe vera gel
Group c Control of non-receipt of any substance
Main outcome variables
Striae; Itching; Erythema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190305042927N1
Registration date:2020-07-26, 1399/05/05
Registration timing:retrospective
Last update:2020-07-26, 1399/05/05
Update count:0
Registration date
2020-07-26, 1399/05/05
Registrant information
Name
sahar bagherian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7710 3995
Email address
bagherian.midwife94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2019-10-01, 1398/07/09
Actual recruitment start date
2019-06-05, 1398/03/15
Actual recruitment end date
2019-11-22, 1398/09/01
Trial completion date
2019-11-22, 1398/09/01
Scientific title
Evaluating the effect of aloe vera gel on prevention of SG in nulliparous woman
Public title
the effect of aloe vera gel on prevention of SG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparus
Single pregnancy
Age:20-35 year
Exclusion criteria:
History of previous striae in the abdomen
History of skin diseases
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software1.0, A simple random list of 3 groups with codes A, B and C for 90 participants was prepared and presented by a statistical consultant. The codes were placed in envelopes in the order of the list provided in the form of small cards by the research colleague, the lids of the envelopes were pasted and the envelopes were numbered in the order in the list obtained from the random assignment software. Envelopes were given to the researcher who was doing the sampling. Eligible individuals were opened to enter the study envelope in order and the group was identified.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researchers, participants, and data analyzers were not aware of the gel type.
After preparing by the Pharmacognosy Center, the gels were named in the same package with codes A and B. At the end of the data analysis, the results were announced to the Pharmacognosy Center and the type of gel of each code was announced by that center.At the same time, the research colleague, who evaluated the outcome by observing and completing the observation checklist, did not know what the study groups (A, B, C) were receiving.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Yemen St. - Shahid Abbas Arabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Services - Headquarters Building 2- Floor 5- Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1197
Health conditions studied
1
Description of health condition studied
Striea gravidarum
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stria score in the Davy checklist
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Davy method: The number of striae in each quarter of the abdomen is scored: "Score zero, no striae", "score one, number 2 striae", "score two, number 3-3 striae" and a total score of 0-0. . The final evaluation of striae severity is done in three groups: "zero without striae", "2-1 moderate striae" and "3-8 severe striae".
2
Description
Severity ofstriae pruritus
Timepoint
8 weeks after the intervention
Method of measurement
It was evaluated by Kamini method with a score of 4-0. Without itching "score 0", mild itching (1-2 times a day) "score 1", moderate itching without disruption of daily work (3-4 times a day) "score 2", severe itching (6- 5 times a day) annoying daily work "score 3" and severe itching throughout the day and disturbing work and sleep "score 4".
3
Description
Severity of striae erythema
Timepoint
8 weeks after the intervention
Method of measurement
By the way of Atval Assessed with a score of 3-0: no erythema "score 0", moderate erythema (bright red or pink) "score 1", symptomatic erythema (red) "score 2", severe erythema (purple) "score 3" Was considered
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" Receive aloe vera gel 75% from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or the equivalent of approximately 3 fingertips with 2 minutes of massage on the entire abdomen.
Category
Treatment - Drugs
2
Description
"Control group 1:" Receive placebo gel (Base gel without active ingredient) from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or approximately the equivalent of 3 fingertips with 2 minutes of massage on the entire abdomen.
Category
Placebo
3
Description
"Control group 2:" During the study (28-20 weeks of pregnancy) did not use any substance in the abdomen
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
East Health Center
Full name of responsible person
Ali Freidonfar
Street address
Shahid Babaei Highway
City
Tehran
Province
Tehran
Postal code
۱۷۷۸۹۴۵۱۸۱
Phone
+98 21 3349 1504
Email
bagherian.midwife94@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Bagherian
Position
Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-Asr Avenue, Vali-Asr and Neiaiesh Highway Intersection, Opposite Rajae Hospital, Nursing and Midwifery School
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Email
bagherian.midwife94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nourossadat Kariman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali-Asr Avenue, Vali-Asr and Neiaiesh Highway Intersection, Opposite Rajaee Heart Hospital,School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Email
n_kariman@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Bagherian
Position
Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-Asr and Neiaiesh Highway Intersection, Opposite Rajaee Heart Hospital, Nursing and Midwifery School
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Email
bagherian.midwife94@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Official request through corresponding researcher
When the data will become available and for how long
One year after article published.
To whom data/document is available
Universities and Research Centers
Under which criteria data/document could be used
Confidentiality and obtaining permission from the main researcher
From where data/document is obtainable
Corresponding authors' email
What processes are involved for a request to access data/document
After emailing and stating the reason for asking for the dat