Study Purpose: Investigation effect of Quercus persica L and Lawsonia inermis L ointment on episiotomy wound healing in primiparous women
Study Plan: Interventional, Randomized, Double Blind, Used Placebo, Single Center, One stage trial
Study Samples: Primiparous women which came to Hajar Hospital of Shahrekord city in 2014 to 2015
Inclusion Criteria: Nullipar (Gravid 1); Pregnancy age 37-42 weeks; Singleton fetus; Not Using special drugs; No disease history; Pulmonary; Sensitivity to herbal medicines; BMI between 19.8 to 26
Exclusion Criteria: History reconstructive surgery on perineal; Failure to comply with the fetus in the mother's pelvis, pelvic examination; Interfere with the progress of labor; Manual removal of placenta; 3rd and 4th degree perineal tear; Prolonged rupture of membrane; Using of vacuum and forceps; abnormal bleeding or hematoma after delivery; Genital Warts; use irregularly ointment
Sample Size: 160
Intervention: using cream twice per day for 10 days, the groups are as below:
1- No intervention
2- Placebo Cream
3- 5% Lawsonia inermis Cream
4- 2% Quercus persica Cream
Each group consist of 40 samples which after elimination of deviations will be 30 samples at least.
Primary outcome measure: Redness, Edema, Bruising, Secretion and Distance between edges of wound
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060122521N1
Registration date:2015-06-27, 1394/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Sanaz Zibanejad
Name of organization / entity
Shahrekord University of Medidal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3330 0613
Email address
zibanejad@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quercus persica L and Lawsonia inermis L ointment on episiotomy wound healing in primiparous women in 2014-2015
Public title
The effect of Quercus persica L and Lawsonia inermis L ointment on episiotomy wound healing in primiparous women in 2014-2015
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Nullipar (Gravid 1); Pregnancy age 37-42 weeks; Singleton fetus; Not Using special drugs as Glucocorticoids, Anticoagulant, Chemotherapy, Suppression of the immune or Radiotherapy; No disease history as impair the healing of chronic diseases such as systemic, heart, renal, Pulmonary, Coagulopathy, Immunocompromised, Connective tissue disorders, Diabetes, Anemia, Mental, Persistent constipation, Hemorrhoids, Hemophilia; Malnutrition; Sensitivity to herbal medicines; BMI between 19.8 to 26; Active skin disease such as allergic disorders; Scar or skin allergy; BV symptoms
Exclusion Criteria: History reconstructive surgery on perineal; Failure to comply with the fetus in the mother's pelvis, pelvic examination; Interfere with the progress of labor (first stage more than 20 hours or second stage more than 2 hours or Cervical dilatation more than 5 cm per hour Fast Vaginal delivery); Manual removal of placenta; 3rd and 4th degree perineal tear; Prolonged rupture of membrane (more than 18 hours); Using of vacuum and forceps; abnormal bleeding or hematoma after delivery; Genital Warts; use irregularly ointment
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
Shahrekord University of Medical Sciences
Street address
Kashani Blvd., Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2014-01-26, 1392/11/06
Ethics committee reference number
1023
Health conditions studied
1
Description of health condition studied
Infection of obstetric surgical wound
ICD-10 code
O86.0
ICD-10 code description
Infection of obstetric surgical wound
2
Description of health condition studied
Haematoma of obstetric wound
ICD-10 code
O90.2
ICD-10 code description
Haematoma of obstetric wound
3
Description of health condition studied
Dehiscence of episiotomy wound
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
Wound Healing
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
2
Description
Edema
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
3
Description
Bruising
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
4
Description
Secretion
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
5
Description
Distance between edges of wound
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
6
Description
Redness
Timepoint
Days 7, 10 and 14
Method of measurement
Reeda Scale
Secondary outcomes
1
Description
Pain Intensity
Timepoint
Days 7, 10 and 14
Method of measurement
Pain Perception Scale
Intervention groups
1
Description
5% Lawsonia inermis Cream, 1 cm, Twice per day, 10 days
Category
Treatment - Drugs
2
Description
Placebo (Osirin) Cream, 1 cm, Twice per day, 10 days
Category
Placebo
3
Description
2% Quercus persica Cream, 1 cm, Twice per day, 10 days
Category
Treatment - Drugs
4
Description
Non Intervention Group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital of Shahrekord
Full name of responsible person
Dr. Sanaz Zibanejad
Street address
Kashani Blvd., Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sepideh Miraj
Street address
Hajar Hospital of Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
1548
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sanaz Zibanejad
Position
PHD in Medical Science
Other areas of specialty/work
Street address
Hajar Hospital of Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
Zibanejad@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sepideh Miraj
Position
PhD in Gynecology
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
SepidehMiraj@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Sanaz Zibanejad
Position
PHD in Medical Sciences
Other areas of specialty/work
Street address
Hajar Hospital of Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
Zibanejad@skums.ac.ir
Web page address
www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)