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Effect of Scrophularia striata plant on episiotomy wound healing in primiparus women

Protocol summary

Summary
The purpose of this study was to determine the effect of Scrophularia striata plant on episiotomy wound healing in primiparus women. In this three -blind clinical trial study, 80 primiparus women referred to Ganjavian hospital in the city of Dezful were randomly assigned to receive Scrophularia striata plant and placebo (n = 40 in each group, Drugs made from plants and Placebo). Inclusion criteria included Age 18-35years, At least 5 primary education, Age between 37-42 weeks of pregnancy,The fetus with cephalic presentation, 5. Vaginal delivery with episiotomy has a length of 3-4 cm medial side and Exclusion criteria included Body mass less than 18.5 and more than 26, Placental, Curettage in the first 24 hours after birth, Symptoms of infection, Anemia, Anal lesions. The initial dose of Scrophularia striata plant and placebo was administered during 24 hours after delivery. After delivery and episiotomy, Mothers for 10 nights, Once during the night, put medicine on the area episiotomy, So that fully cover the wound and put a sterile gauze on it. Wound healing was measured by REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Adhesive) on 5th, 10th and 21th day after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111619977N1
Registration date: 2016-09-18, 1395/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
Nasibeh Sharifi
Name of organization / entity
Depatment of Midwifery ,Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 918 345 4138
Email address
nasibeh.sharifi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Reproductive Health Research Center School of Nursing and Midwifery Ahvaz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Scrophularia striata plant on episiotomy wound healing in primiparus women
Public title
Effect of Scrophularia striata plant on episiotomy wound healing in primiparus women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Age 18-35years, Age between 37-42 weeks of pregnancy, The fetus with cephalic presentation,, Vaginal delivery with episiotomy has a length of 4-3 cm medial side and Exclusion criteria included: Body mass less than 18.5 and more than 26, Placental, Curettage in the first 24 hours after birth, Symptoms of infection, Anemia, Anal lesions
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences approved the study design
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan highway, Ahvaz
City
Ahvaz
Postal code
Approval date
2013-05-20, 1392/02/30
Ethics committee reference number
Ajums.rec.1392.95

Health conditions studied

1

Description of health condition studied
Episiotomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Primary outcome 1: Redness
Timepoint
5th, 10th and 21th day after delivery
Method of measurement
Observation and examination ((REEDA) scale)

2

Description
Primary outcome 2: Edema
Timepoint
5th, 10th and 21th day after delivery
Method of measurement
Observation and examination ((REEDA) scale)

3

Description
Primary outcome 3: Ecchymosis
Timepoint
5th, 10th and 21th day after delivery
Method of measurement
Observation and examination ((REEDA) scale)

4

Description
Primary outcome 4: Discharge
Timepoint
5th, 10th and 21th day after delivery
Method of measurement
Observation and examination ((REEDA) scale)

5

Description
Primary outcome 5: Adhesive
Timepoint
5th, 10th and 21th day after delivery
Method of measurement
Observation and examination ((REEDA) scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Drugs made from Scrophularia striata plant. Cream base is containing stearic acid, cetyl alcohol, glycerin, triethanolamine and asprmasty. Initial dose was administered within 24 hours after delivery. Mothers for 10 nights, Once during the night, put medicine on the area episiotomy.
Category
Treatment - Drugs

2

Description
Placebo group: Placebo Cream enter the carrier containing the color fits perfectly similar appearance were provided with medication in appropriate circumstances. Initial dose was administered within 24 hours after delivery. Mothers for 10 nights, Once during the night, put medicine on the area episiotomy.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ganjavian Hospital in Dezful city
Full name of responsible person
Street address
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Reproductive Health Promotion Research Center, Schools of Nursing & Midwifery, Ahvaz Jundishapur Un
Full name of responsible person
Ms Poorandokht Afsharifi(Head of the Rrproductive Health Promotion Research Center)
Street address
School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences; Golestan highway; Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reproductive Health Promotion Research Center, Schools of Nursing & Midwifery, Ahvaz Jundishapur Un
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
School of Nursing and Midwifery,Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnaz Najar
Position
Instructor, Faculty of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Ahvaz Jundishapur University of Medical Sciences; Ahvaz
City
Ahvaz
Postal code
Phone
+373 8331
Fax
Email
najarshanaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing & Midwifery ,Ahvaz Jundishapur University of Medical Sciences,
Full name of responsible person
Nasibeh Sharifi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz University of Medical Sciences, Golestan highway,Ahvaz
City
Ahvaz
Postal code
Phone
+373 8331
Fax
Email
nasibe.sharifi@yahoo.comnasibeh.sharifi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasibeh Sharifi
Position
Master of Midwifery
Other areas of specialty/work
Street address
City
School of Nursing & Midwifery, Ahvaz Jundishapur University of Medical Science
Postal code
Phone
+98 613738331
Fax
Email
nasibe.sharifi@yahoo.com nasibeh.sharifi@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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