Evaluation and comparison of repair time, amount of bleeding, and pain at the episiotomy site created with Episizer-60 type scissors in comparison with Mayo type scissors in primiparous pregnant women
This study was performed to compare episiotomy with Mayo scissors in comparison with EPISCISSORS 60.
Design
A clinical trial with the control group with parallel groups; Randomized; Phase 4 on 64 patients. A table of random numbers is used for randomization.
Settings and conduct
The clinical trial study was performed on 64 women with first delivery referred to Al-Zahra hospital in Isfahan and was randomly divided into two groups of 32 intervention and control. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers aged 18-40 years; Normal delivery and first delivery. Non-inclusion criteria: the age is more than 41 years; Cesarean delivery; Multiparity; Obesity (BMI more than 30); Third trimester bleeding; Maternal diabetes; chronic diseases.
Intervention groups
In the intervention group, with the progression of labor pain and the identification of the baby's head during delivery, a gynecologist and obstetrician; With an episiotomy angle of 60 degrees and with the help of the model of Episcissors - 60; Gives an episiotomy incision at the perineal site. In the control group, as the labor pain progressed and the baby's head became clear during delivery, the obstetrician and gynecologist make an episiotomy incision in the perineal area with the help of Mayo model scissors.
Main outcome variables
Pain at the episiotomy site, Episiotomy incision repair time; the time of incision repair; the amount of bleeding until the incision is repaired.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027998N8
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-15, 1400/01/26
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of repair time, amount of bleeding, and pain at the episiotomy site created with Episizer-60 type scissors in comparison with Mayo type scissors in primiparous pregnant women
Public title
Comparison of perineal incision (episiotomy) in using two different types of scissors.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-40 years old
Normal delivery
The first delivery
Exclusion criteria:
Multiparity
Obesity (BMI more than 30)
Bleeding in third trimester
Chronic diseases of the mother
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The random method is simple and a randomization tool is a random numbers table that the researcher considers to read the numbers from top to bottom in which the even numbers are for intervention A and the odd numbers for intervention B or the control group.
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 Isfahan University of Medical Sciences
Street address
School of Medicine, Isfahan University of Medical Sciences and Health Services,Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.MUI.MED.REC.1399.796
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
Time required to suture the episiotomy site
Timepoint
During episiotomy repair
Method of measurement
Timer (minutes)
2
Description
Pain at the episiotomy site
Timepoint
The day after delivery
Method of measurement
According to the pain questionnaire
3
Description
Time to repair the episiotomy incision
Timepoint
Two weeks after delivery
Method of measurement
Examination by a specialist and asking from the patient
4
Description
The amount of bleeding until suturing episiotomy site
Timepoint
Immediately after perineal incision and until the end of perineal repair time
Method of measurement
Number of used 5 * 5 cm pads
Secondary outcomes
1
Description
Pain during intercourse (dyspareunia)
Timepoint
Three months after delivery
Method of measurement
Asking from participants
Intervention groups
1
Description
Intervention group: in this group with the progression of labor pain and the identification of the baby's head during labor, a gynecologist and obstetrician, with an episiotomy angle of 60 degrees and with the help of scissors - 60, Gives an episiotomy incision at the perineum.
Category
Treatment - Other
2
Description
Control group: in this group, with the progression of labor pain and the identification of the baby's head during delivery, a gynecologist and obstetrician with the help of Mayo model scissors; Gives an episiotomy incision at the perineal site.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital in Isfahan
Full name of responsible person
Maryam Haji Hashashemi
Street address
Al-Zahra Educational and Medical Center ,Safa boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mojgan Mortazavi
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 8134
Email
office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Sattary Aberoo
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine; Isfahan University of Medical Sciences and Health Services; Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 8134
Email
farnaz.sattariabro@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Haji Hashemi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Isfahan University of Medical Sciences and Health Services, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 8134
Email
hajhashemy73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Haji Hashemi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Isfahan University of Medical Sciences and Health Services, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
009837928134
Email
hajhashemy73@yahoo.com
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