Selection of suitable suture for restoration of episiotomy to reduce complications, decrease hospitalization and frequent visits, and improve the quality of life of women after Vaginal delivery.
Design
Three arm parallel group Non-Blind Randomized Clinical Trial Study
Settings and conduct
Patients referring to the delivery unit of the Besat Hospital in Sanandaj, who Need Episiotomy repaire due to Vaginal Delivery, are repaire sequentially by chrome-plated gout, polygalactine 910 and fast-grained wicryl "smi made in Belgium" branded by the Exeter Saban Was provided.
Participants/Inclusion and exclusion criteria
inclusion:
All women undergo episiotomy and episiotomy repair procedure
Exclusion:
Includes patient with diabetes, chronic diseases and collagen vasculardisease , low socioeconomic status, and very obese patients (BMI above 35), patients treated with corticosteroids, prolonged labor and prolong Premature Rupture of Membranes
Intervention groups
Patients allocate in 3 groups with chromic cutgut, poly-galactin 910 and fast-absorbent vikril treatment
Main outcome variables
Episiotomy repair; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141208020249N5
Registration date:2019-02-01, 1397/11/12
Registration timing:retrospective
Last update:2019-02-01, 1397/11/12
Update count:0
Registration date
2019-02-01, 1397/11/12
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2017-10-11, 1396/07/19
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
2018-06-21, 1397/03/31
Scientific title
Comparison of chromic cutgot and polygalactin 910 and vicryl rapid in episiotomy repair
Public title
Episiotomy repair success with different suture wire
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient who had episiotomy and requires repair of episiotomy
Exclusion criteria:
People with diabetes
People with chronic disease
People with collagen vascular disease
Low socioeconomic conditions
BMI above 35
Corticosteroid treatment
Prolonged delivery
Prolonged premature rupture of embryonic membrane
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Three-block randomization methods by using random number tables, patients divided into three groups (chrome-plain cat-gut and poly-galactin 910 and fast-absorbent vikriil).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
IR.MUK.REC.1396/188
Health conditions studied
1
Description of health condition studied
Episiotomy repair
ICD-10 code
O70
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
Episiotomy Repair
Timepoint
2, 7, 42 day
Method of measurement
Observation and Examination
2
Description
pain
Timepoint
2, 7, 42 day
Method of measurement
Based on the patient's expression, one to nine (1-3 mild, 4-6 moderate, 7-9 severe)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: suture with chromic cutgut
Category
Treatment - Surgery
2
Description
Intervention group: suture with polygalactin 910
Category
Treatment - Surgery
3
Description
Intervention group: suture with vicryl
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Chonur Limoei
Street address
Vakil Crossroad, Besat Hospital, Department of Obstetrics and Gynecology
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3328 2004
Email
lchnour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Sanandaj, Kurdistan University of Medical Sciences, opposite Shadi Hotel, Kurdistan University of Medical Science, POB 6617713446 Management of medical research and information
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
khalafi.behzad70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Sholeh Shahgheibi
Position
Associate professor of Gny & Obs
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vakil Crossroad, Besat Hospital, Department of Obstetrics and Gynecology
City
sanandaj
Province
Kurdistan
Postal code
0000000000
Phone
+98 87 3328 2004
Email
shahgheibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sholeh Shahgheibi
Position
Associate professor of Gny & Obs
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vakil Crossroad, Besat Hospital, Department of Obstetrics and Gynecology
City
sanandaj
Province
Kurdistan
Postal code
0000000000
Phone
+98 87 3328 2004
Email
shahgheibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
با ارائه درخواست به معاونت تحقیقات و فناوری و تایید کمیتد اخلاق - دکتر شعله شاه غیبی
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.