The purpose of this study is evaluating the effect of Olive leaf extract ointment on pain intensity and healing wound of episiotomy. This randomize clinical trial will done on 90 primiparous women who admitted in Shiraz Hafez and Hazrat Zeinab hospital (With Inclusion criteria contain: Age between 17 to 35 years, Age between 17 to 35 years; Primiparous women; Normal vaginal delivery; Full term singleton pregnancy with cephalic presentation; Gestational age between 37 to 42 weeks; Medio-lateral episiotomy without extending the incision and tear of grade 3 and 4; Body mass index <30; Absence of reconstructive surgery in the perineal area; Absence of illness, Not using drugs effecting on wound healing , Exclusion criteria: Failure to use the correct and consistent command of ointment; Abnormal vaginal bleeding after delivery; Postpartum perineal manipulation; Episiotomy infection; The need for episiotomy stitches this location; Sensitivity to ointments). Eligible women will be allocated to three the prevention and control groups with block randomization. Ointments ( Olive and placebo made by pharmaceutical industries Dana Kasian Lorestan) will be used 3 times a day and for 10 days with amount of one knuckle (1 gram) by mother. In the control group 10% betadine solution of 3 tablespoons in 4 glasses of water , 3 times a day for 10 days will be used for sitz bath . Pain intensity and Healing of episiotomy in 5 innings (1,3,7,10,14 days) after episiotomy will evaluated.
General information
Acronym
Ointment Pain Episiotomy Shiraz
IRCT registration information
IRCT registration number:IRCT2015062422908N1
Registration date:2015-08-02, 1394/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Sara Sepasi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3823 2764
Email address
stud2280234432@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-04, 1394/02/14
Expected recruitment end date
2015-08-05, 1394/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of olive leaf extract ointment on pain intensity and healing wound of episiotomy in Primiparous women
Public title
Effect of olive leaf extract ointment on pain intensity and healing wound of episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria contain: Age between 17 to 35 years, Age between 17 to 35 years; Primiparous women; Normal vaginal delivery; Full term singleton pregnancy with cephalic presentation; Gestational age between 37 to 42 weeks; Medio-lateral episiotomy without extending the incision and tear of grade 3 and 4; Body mass index <30; Absence of reconstructive surgery in the perineal area; Absence of illness, Not using drugs effecting on wound healing .
Exclusion criteria: Failure to use the correct and consistent command of ointment; Abnormal vaginal bleeding after delivery; Postpartum perineal manipulation; Episiotomy infection; The need for episiotomy stitches this location; Sensitivity to ointments .
Age
From 17 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commity of shiraz university of medical sciences
Street address
Zand street Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
94-7472
Health conditions studied
1
Description of health condition studied
episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Pain intensity
Timepoint
4 hours after delivery (first day after delivery) ,3 days after delivery,7 days after delivery, 10 days after delivery,14 days after delivery.
Method of measurement
Visual Analouge Scale
2
Description
Healing of episiotomy
Timepoint
4 hours after delivery (first day after delivery) ,3 days after delivery,7 days after delivery, 10 days after delivery,14 days after delivery.
Method of measurement
REEDA scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: Olive leaf extract ointment 3 times a day for 10 days (preparation and packaging by Dana kasian Khorram Abad company) as much as one finger (equivalent to 1 gram) will be used locally on the episiotomy .
Category
Treatment - Drugs
2
Description
The placebo group: Placebo ointment 3 times a day for 10 days (preparation and packaging by Dana kasian Khorram Abad company) as much as one finger (equivalent to 1 gram) will be used locally on the episiotomy .
Category
Placebo
3
Description
Control group: 10% betadine solution of 3 tablespoons in 4 glasses of water , 3 times a day for 10 days will be used for sitz bath.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zainab Hospital Shiraz
Full name of responsible person
Sara Sepasi
Street address
Shiraz Valiasr street
City
Shiraz
2
Recruitment center
Name of recruitment center
Hafez Hospital Shiraz
Full name of responsible person
Sara Sepasi
Street address
Shiraz Chamran Boulevard
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
7th Floor, Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Scienses
Full name of responsible person
Maasumeh Kaviani
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Shiraz Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
kavianimaasumeh@yahoo.com kavianm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Maasumeh Kaviani
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Shiraz Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
kavianimaasumeh@yahoo.com kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Maasumeh Kaviani
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Shiraz Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
kavianimaasumeh@yahoo.com kavianm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)