The clinical trial will involve 84 primiparous women admitted for labor and episiotomy in 17Shahrivar hospital in Saveh, Iran. They are randomly allocated into two groups: intervention (Aloevera gel twice daily and 2cm of gel for 10 days) and control (receiving the hospital routine betadaine sithz bath twice daily for 10 days). An initial assessment will be done for distinction of pain and wound healing level immediately after episiotomy and 4h after episiotomy intervention will start. Pain level and wound healing will be evaluated in 1, 7 and 10 days after episiotomy. The participant's pain will record on VAS and wound healing on REEDA scale (Redness, edema, Echymosis, discharge, Approximation). Researcher will request mother to inform any allergic reaction or infection to researcher for curative action. For blinding, drug administration will be done with researcher and evaluating data will be done with her colleague.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112258517N1
Registration date:2012-01-08, 1390/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Masoumeh Sabzaligol
Name of organization / entity
Iran, arak,arak medical university
Country
Iran (Islamic Republic of)
Phone
+98 25 5234 3395
Email address
sabzaligol@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
arak university of medical sience and Barij essence co.
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-03-29, 1391/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloevera gel on wound healing after episiotomy
Public title
The effect of Aloevera gel on wound healing after episiotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous women with episiotomy without laceration and instrumental delivery; singleton; without systemic chronic disease for example heart and pulmonary diseases, coagolative and connective tissue disease, diabetes, anemia, immune system deficiency, hemophilia, malnutrition, psychological disease, eclampsia, preclampcia, premature rupture of membrane more than 24 hours; prolonged labor and precipitate labor; addiction; volvovaginitis and hematoma in perineum during 12h after delivery and BMI in range18 to21.
Exclusion criteria: no cooperation, allergies (rash, redness and edema); infection; new trauma; not coming for follow-up.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aak University of Medical Sciences
Street address
Medical pardis, Basij Sq, Sardasht, Arak, Iran
City
Arak
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
12-114-90
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O71.9
ICD-10 code description
Obstetric trauma, unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
At days 1, 7 and 10
Method of measurement
VAS scale
Secondary outcomes
1
Description
Wound healing
Timepoint
At days 1, 7 and 10
Method of measurement
Reeda scale
Intervention groups
1
Description
Intervention group will receive aloevera gel (twice daily and 2cm of gel for 10 days). A initial assessment will be do for distinction of pain and wound healing level immidiate after episiotomy and 4h after episiotomy intrvention will do. pain level and wound healing will assess in day 1,7 and 10.
Category
Treatment - Drugs
2
Description
In control group routin care is betadine sithz bath twice a day (for 10 days). A initial assessment will be do for distinction of pain and wound healing level immidiate after episiotomy and 4h after episiotomy intrvention will do. pain level and wound healing will assess in day 1,7 and 10.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Saveh's 17 shahrivar hospital
Full name of responsible person
Masoume Sabzaligol
Street address
Koshesh panah,Kaveh industerial city,Saveh
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sience
Full name of responsible person
Saeeid changizi ashtiani
Street address
medical pardis,Basij Sq,Sardasht,arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university of medical sience
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
Arak University of Medical Science
Full name of responsible person
Masoumeh Sabzaligol
Position
Ms
Other areas of specialty/work
Street address
Koshesh panah, Kaveh industerial city, Saveh
City
Saveh
Postal code
Phone
+98 25 5234 3395
Fax
Email
sabzaligol@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Sabzaligol
Position
Faculity of Nursing
Other areas of specialty/work
Street address
koshesh panah, kaveh industerial city, Saveh
City
Saveh
Postal code
Phone
+98 25 5234 3395
Fax
Email
sabzaligol@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Sabzaligol
Position
MSc
Other areas of specialty/work
Street address
City
Saveh
Postal code
Phone
+98 25 5234 3395
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)