This study is conducted to determine the effect of topical cream on wound healing and episiotomy pain in primiparous women referred to the hospital of Amiralmomenin in Zabol city.
Design
Clinical trial, with control group, randomized, double blind
Settings and conduct
This study is done in Amiralmomenin hospital in Zabol city. The primiparus women that have inclusion criteria are randomized in two groups, control and intervention. Participants are fallowed up for 10 days. This study is double blind. The researcher and participants during the study not have any information about the type of creams.
Participants/Inclusion and exclusion criteria
primiparous women with mediolatral episiotomy who want to participate in the study. no allergy to Myrtus Communis cream. Attending at clinic for fallow up.
Intervention groups
The intervention group receives Myrtus Communis cream and
control group receives placebo.
Main outcome variables
Better wound healling, Pain relief, reduce the risk of infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180303038932N1
Registration date:2018-03-15, 1396/12/24
Registration timing:prospective
Last update:2018-03-15, 1396/12/24
Update count:0
Registration date
2018-03-15, 1396/12/24
Registrant information
Name
fatemeh mirzaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3228 1474
Email address
f.mirzaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Myrtus Communis cream on prineal healing and pain intensityof episiotomy in primiparous women
Public title
Evaluating the effect of Myrtus Communis cream on episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the primiparus womens that have episiotomy incision.
Gestational age between 42-37 weeks
Body mass index between 18.5-26.
Having skill of reading and writing.
Baby weight between 2500- 4000 g.
Rupture of the membrane less than 24 hour.
No hematoma in episiotomy incision area.
No previous history of surgery and visible lesions in the perineal area.
No manual placenta extraction .
Single pregnancy with cephalic presentation.
Exclusion criteria:
Do not go to clinic on fallow up days
Do not want to continue to participate in the study
Do not regular use of the cream
Have allergy against Myrtus Communis cream
Having sex in the first five days after delivery
Having remanipulation after repair episiotomy
Having severe hemorrhage in first 24 hours after delivery
Age
From 18 years old to 35 years old
Gender
Female
Phase
0
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by Excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and participants will be kept blind during the study and do not know which group receive drug and which receive placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of medical sciences
Street address
Vali Asr St., Niayesh HW. Cross Section, Tehran, Tehran province, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.SBMU.PHNM.1396.847
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O70
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
wound healing of episiotomy
Timepoint
At the beginning of the study and day 5,10 after starting the cream
Method of measurement
Improvement control form
2
Description
intensity of pain
Timepoint
At the beginning of the study and day 5,10 after starting the cream
Method of measurement
Measuring ruler pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Myrtus Communis cream, 10%, 5 mg, twice a day, for 10 day
Category
Treatment - Drugs
2
Description
Control group: Placebo cream, 10%, 5 mg, twice a day, for 10 day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Ali Hospital
Full name of responsible person
Fatemeh Mirzaee
Street address
Km 5 Road of Zabol-ZAhedan
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861795361
Phone
+98 54 3229 5121
Fax
+98 54 3229 5121
Email
fatemehmirzaie6526@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vali Asr St., Niayesh HW. Cross Section, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mirzaee
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Sam Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861795361
Phone
+98 54 3228 1474
Fax
Email
f.mirzaie@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mirzaee
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Sam Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861795361
Phone
+98 54 3228 1474
Fax
Email
f.mirzaie@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mirzaee
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Sam Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861795361
Phone
+98 54 3228 1474
Fax
Email
f.mirzaie@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available