Evaluation of the effect of leg wrapping with elastic bandage for the prevention of Post spinal hypotension in cesarean section : A randomized clinical trial
Determining the effect of leg wrapping with elastic bandage for prevention of post spinal hypotension in cesarean section
Design
In this clinical trial, with Phase 2-3, 64 patients 18-46 years and candidate for cesarean section are randomly placed in two groups: using elastic bandages in the lower limbs and the control group.
Settings and conduct
In 32 of the 64 patients, candidates for cesarean section under spinal anesthesia in Fatemieh Hospital of Hamadan,immediately before spinal anesthesia, lower limbs are high held for 1 minute at a 45-degree, then elastic bandages are tied from ankles to the knees while in 32 patients of control group (without the use of bandages) they are subjected to spinal anesthesia
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 46 years; term pregnancy (37 weeks and more); Physical Status (ASA) Class 1 and 2; Candidate for cesarean section under spinal anesthesia; Satisfaction to participate in the research
Exclusion criteria: respiratory disease; Hypertension; Diabetes; Heart failure and cardiac arrhythmia; Multiple pregnancies; Eclampsia and preeclampsia; Emergency cesarean sectio
Intervention groups
Patients are randomly assigned to Group A (lower limbs bandage) and B group (without lower limbs bandage).
Main outcome variables
Hypotension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120915010841N23
Registration date:2020-06-29, 1399/04/09
Registration timing:registered_while_recruiting
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of leg wrapping with elastic bandage for the prevention of Post spinal hypotension in cesarean section : A randomized clinical trial
Public title
Evaluation of the effect of elastic bandage on Post spinal hypotension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 46 years
With term pregnancy (37 weeks and more)
Physical Status (ASA) Class 1 and 2
Candidate for cesarean section under spinal anesthesia
Satisfaction to participate in the research
Exclusion criteria:
Patients with respiratory disease
Hypertension
Diabetes
Heart failure and cardiac arrhythmia
Multiple pregnancies
Eclampsia and preeclampsia
Emergency cesarean section
Age
From 18 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a randomized block design with four replications is used. we provide four paper sheets. We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table. With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two elastic bandage and control groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume.
Blinding (investigator's opinion)
Single blinded
Blinding description
In group A, immediately before spinal anesthesia, each lower limb is covered by an elastic bandage and covered by clothes. Since the bandage is performed by an anesthesiologist, the assistant who will measure and record the study result will not know if the bandage has been performed or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2020-06-13, 1399/03/24
Ethics committee reference number
IR.UMSHA.REC.1399.297
Health conditions studied
1
Description of health condition studied
Post spinal anesthesia hypotension in C/S
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypotension
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15minutes, then every 10 minutes until the end of the surgery
Method of measurement
Automatic non-invasive blood pressure device
Secondary outcomes
1
Description
Systolic and Diastolic Blood Pressure
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery
Method of measurement
En Automatic non-invasive blood pressure device
2
Description
Heart Rate
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery
Method of measurement
pulse oximetry
3
Description
Nausea and Vomiting
Timepoint
During and after surgery
Method of measurement
Observation
4
Description
New born Apgar
Timepoint
1&5 minutes after delivery
Method of measurement
Apgar Score
5
Description
The amount of ephedrine have been consumed
Timepoint
During surgery
Method of measurement
mg
6
Description
The amount of atropine have been consumed
Timepoint
During surgery
Method of measurement
mg
Intervention groups
1
Description
Intervention group: Immediately before the spinal anesthesia, first lower limbs are high held for 1 minute at a 45-degree for venous derenage, second elastic bandages(a length of 4 meters and a width of 15 centimeters) are tied from ankles to the knees and limbes will be covered by clothes.
Category
Prevention
2
Description
Control group: They are subjected to spinal anesthesia without the use of elastic bandages
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemy hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.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