Determining the effect of using a abdominal binder on the amount of vaginal bleeding, pain intensity and mobility after cesarean section
Design
A clinical trial with a control group, parallel, one-way blind, randomized on 184 patients, RAS software will be used for randomization.
Settings and conduct
It will be done in Isfahan hospitals. Eligible people will be selected by easy method and will be randomly assigned to 2 groups of 92 people in blocks of 4 and 6. The data analyzer is unaware of the division of the samples into the control and intervention groups.
Participants/Inclusion and exclusion criteria
No underlying disease, first and second cesarean section, term infant, spinal anesthesia
Intervention groups
In the intervention group, along with routine care, a Paksaman abdominal binder, made in Iran, will be closed after cesarean section with a suitable patient size and a 10% reduction in the circumference of the abdomen, and the control group will receive routine care.
Main outcome variables
Measurement of pain intensity after the intervention every 6 hours for 24 hours, the amount of vaginal bleeding will be measured by calculating the amount of hemoglobin and hematocrit before surgery and 6 and 24 hours after surgery. mobility is measured from a six-minute walk test. Side effects including housing received will be recorded every 6 hours for 24 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211024052856N1
Registration date:2021-11-08, 1400/08/17
Registration timing:prospective
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
Fatemeh Anvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4362 2050
Email address
f.anvari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using abdominal binder on the amount of vaginal bleeding, pain intensity and mobility after cesarean section
Public title
Evaluation of the effect of using abdominal binder on the amount of vaginal bleeding, pain intensity and mobility after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Spinal anesthesia
Do not use anti-anxiety and hypnotic drugs and painkillers
No underlying disease (neuromuscular disorders, hypertension, kidney disease, heart disease)
BMI between 18/5 to 29/5
Term baby
Uncomplicated pregnancy such as absence of eclampsia and preeclampsia
Do not have any coagulation disorders or use anticoagulants
Pfannenstiel incision on the skin and kerr incision on the uterus
Exclusion criteria:
Intolerance of the abdominal binder by the patient
Reluctance to continue participating in the study
Severe postoperative bleeding
Damage to body tissues during cesarean section such as damage to the urinary tract and gastrointestinal tract
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random Allocation Software (M. Saghaei),patients were allocated using random blocks of four or six in a 1:1 ration to a group that received abdominal binders or a control group. Group assignments were written down and placed into sequentially numbered opaque envelopes.The allocation was performed by an individual. who was masked to enrollment, data collection.Following cesarean delivery and recording demographic data ,eligible patients’ names were written on envelopes; the envelopes were ultimately opened by one of the researchers and patients were then allocated to the intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is unaware of the division of the samples into the control and intervention groups.
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
Isfahan University of Medical Sciences,Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.MUI.MED.REC.1400.444
Health conditions studied
1
Description of health condition studied
Delivery by elective cesarean section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
pain
Timepoint
6 hours after intervention, 12 hours after intervention, 18 hours after intervention and 24 hours after intervention
Method of measurement
Visual analog scale
2
Description
The amount of vaginal bleeding
Timepoint
Before intervention, 6 and 24 hours after intervention
Method of measurement
Measurement of hemoglobin and hematocrit using Complete Blood Count test
3
Description
Mobility
Timepoint
12 and 24 hours after the intervention
Method of measurement
Six minute walk test
Secondary outcomes
1
Description
Painkillers
Timepoint
6, 12, 18 and 24 hours after the intervention
Method of measurement
Registration in the questionnaire based on patient records
Intervention groups
1
Description
In the intervention group, in addition to routine care, the patient's abdomen will be closed with a abdominal binder( Paksaman, made in iran) after cesarean section, besides receiving routine care and with regard to a 10% reduction of abdominal circumference. For application of the appropriate abdominal binder, the women’s abdomen measured by standard meter first; then, according to the abdominal circumference, in abdominal circumference fastened for 24 houre after transfer of the patient to the surgery ward. abdominal binder will close in 24 hours. At the end of each shift, the abdomen will be examined and will be open from 12 pm to 6 am.
Category
Treatment - Other
2
Description
Control group: they receive routine care and medication
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Fatemeh Anvari
Street address
Beheshti hospital.,Motahhari street
City
Isfahan
Province
Isfehan
Postal code
5354181848
Phone
+98 31 3234 6338
Email
Beheshti_hospital@nm.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Fatemeh Anvari
Street address
Al-Zahra hospital.,Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
AL-Zahra_hospital@nm.mui.ac.ir
3
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Fatemeh Anvari
Street address
Amin Hospital., Sanbolistan Alley.,Ibn Sina St
City
Isfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
Amin_hospital@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences,Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ah_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Soheila Bakhtiari
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7510
Email
bakhtiari@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Bakhtiari
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7510
Email
bakhtiari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Bakhtiari
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7510
Email
bakhtiari@nm.mui.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
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
Title and more details about the data/document
Individual participant data collected for the primary outcome measures
When the data will become available and for how long
After publication for one year
To whom data/document is available
For all people who request data
Under which criteria data/document could be used
It is allowed to perform any analysis on the data, but use of data for publication is not allowed.
From where data/document is obtainable
Corresponding author of article
What processes are involved for a request to access data/document
After requesting the data by email to corresponding author, the data will be sent after a maximum period of one week