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The effect of living room of hydro-alcoholic extract of grass plant on repair of episiotomy wounds of nulliparous women delivered in Salman Farsi city hospital in Bushehr in 1395.

Protocol summary

Summary
This study was a double-blind clinical trial with the aim of investigating the effect of bathing the hydroalcoholic extract of grass extract on episiotomy ulcer in nulliparous women who were delivered at Salman Farsi Hospital in Bushehr in 1395.Episiotomy means the cutting of the superficial muscles and the skin and the vaginal wall, and in the second stage of labor, the perineal tissue is given to widen the ulcer output at birth. 60 primitive women referring to Salman Farsi Hospital for normal delivery, after obtaining satisfaction and control of entry and exit criteria, are randomly selected by permutation block method as research units in two groups of herbal and placebo. For the first 4 hours after the episiotomy repair is completed before the intervention, after washing the episiotomy with wate, 10 cc of the hydroalcoholic extract of the grass extract from the crucible is dissolved in 5 liters of water and the mother sits in the solution for 10 minutes, and 2 It uses the bath within 7 days of deliveryThen, 4 hours after the end of episiotomy repair before the intervention, and on the third, seventh and tenth days by Rida Instruments, 5 criteria for wound healing include redness, swelling, bruising, wound secretion, and wound edema affinity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016120331219N1
Registration date: 2017-07-03, 1396/04/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-03, 1396/04/12
Registrant information
Name
Zahra Yazdanpanahi
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4255
Email address
zahraa.sarbaz@gmail.com
Recruitment status
Recruitment complete
Funding source
vice chancellor for research Shiraz University of medical sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of living room of hydro-alcoholic extract of grass plant on repair of episiotomy wounds of nulliparous women delivered in Salman Farsi city hospital in Bushehr in 1395.
Public title
The effect of myrrh in healing episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Major entry into the study: Primipara; gestational age of 42-37 weeks; normal delivery with middle-episiotomy; Monogamous; cephalic presentation; pre-pregnancy BMI in the range of 25>; no history of regenerative surgery on the vagina and perineum; Absence of specific disease (anemia, cardiovascular disease, diabetes, immune disease, liver disease, depression, absence of coagulation disorders, preeclampsia and infectious diseases); the absence of extension of the cutaneous length and the degree of rupture of the third and fourth Or rupture other than episiotomy; non-smoking during pregnancy; absence of varicose veins in the perineum; There are no genital warts and STDs; the baby is not large and not accompanied by dystocia; lack of proximity and heavy work. Major outcomes of the study: Manual exits; Abnormal vaginal bleeding postpartum; Hematoma formation; Postpartum fever and chills (fever equal to or greater than 38 ° C); Perineal manipulation after delivery; Creation of episiotomy site infection; The need for resection of the episiotomy; the use of any other cream or ointment other than what the researcher received; the skin sensitization resulting from the use of the hydroalcoholic extract of the grass plant; the unwillingness to continue the study; the lack of use According to orders.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block permutation methods

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of Medical Sciences
Street address
Zand Street,Shiraz University of Medical Sciences Central building.
City
Shiraz
Postal code
71345-1978
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.205

Health conditions studied

1

Description of health condition studied
Episiotomy wound healing
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
Repair episiotomy wounds
Timepoint
Day three, seventh and tenth after childbirth
Method of measurement
Rida Tool

Secondary outcomes

1

Description
Episiotomy wound healing
Timepoint
Day three, seventh and tenth after childbirth
Method of measurement
Rida Tool

Intervention groups

1

Description
In the intervention group, 10 cc of Hydroalcoholic Extract were dissolved in 5 liters of water and taken twice a day for 7 days in the form of a bath in the living room.
Category
Treatment - Drugs

2

Description
In the control group, 10 cc of the placebo were dissolved in 5 liters of water and treated twice daily for 7 days in the form of a bath.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Salman Farsi Hospital
Full name of responsible person
Zahra Sarbaz
Street address
Three streets Social Security, Sbzabad Street.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Shiraz university of medical sciences
Full name of responsible person
Dr.Masum Masumpur
Street address
Shiraz University of Medical Sciences, Shiraz headquarters,Zand Street,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research 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
School of Nursing and Midwifery,Shiraz University of Medical Sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Master of midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
+98 71 3647 4255
Email
yazdanz@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Master of midwives
Other areas of specialty/work
Street address
Science center building,Zand Street
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4255
Fax
+98 71 3647 4252
Email
yazdanz@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
ZahraSarbaz
Position
masters student
Other areas of specialty/work
Street address
Headquarters of medical sciences, Zand Street
City
Shiraz
Postal code
7514737758
Phone
+98 77 3354 1851
Fax
+98 77 3354 1850
Email
Zahraa.sarbaz@gmail.com
Web page address
www.sums.ac.ir

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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