Study of manual left uterus tilting role in preventing the hypotension during elective cesarean section under spinal anesthesia
Design
َA randomized clinical trial with parallel groups , with blinded outcome assessment, sample size 70 persons.
Settings and conduct
This study takes place in the Yas hospital. Research information will be recorded in the questionnaire. Finally, the data will be gathered through patients' files and questionnaires and will be analyzed by SPSS software with blinded outcome assessment (The analyst does not know which group is the intervention group and which is the control group).
Participants/Inclusion and exclusion criteria
inclusion criteria: women, elective cesarean section, aged 18 to 40 years
exclusion criteria: multiple pregnancy,placental abnormalities,uncontrolled underlying disease
Intervention groups
In the intervention group, right after spinal anesthesia with 2.5 Bupivacaine 0.5% and supine position, in the sterile setting the top border of uterus will deviate to left by anesthesiologist hand staying right side of the patient until infant and placenta will be delivered. The mother's blood pressure and heart rate will be measured and recorded in certain moments also patient's nausea and surgeon satisfaction will be noted. in the control group all steps will be done except uterus deviation.
Main outcome variables
Mother's systolic and diastolic blood pressure ; mother's heart rate; amount of mother's nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042559N1
Registration date:2020-05-29, 1399/03/09
Registration timing:retrospective
Last update:2020-05-29, 1399/03/09
Update count:0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Mina Amirmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7757 4159
Email address
m-amirmohammadi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of hemodynamic effects of manual tilting of the uterus to left during cesarean section under spinal anesthesia
Public title
ٍEffect of manual tilting of the uterus in cesarean section
In a simple random sampling, 70 patients are selected. A number of 70 papers are prepared. The word "intervention" is written on half of the papers and the word "control" is written on the other half. The papers are placed in envelopes and are sealed. Each patient picks up an envelope and is assigned to the intervention or control group based on the paper in the envelope.
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 Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.358
Health conditions studied
1
Description of health condition studied
Hypotension during cesarean section under spinal anesthesia
ICD-10 code
I95.81
ICD-10 code description
Postprocedural hypotension
Primary outcomes
1
Description
mother's Blood pressure during cesarean section
Timepoint
Mother's systolic and diastolic blood pressure in the following moments: before injection of spinal anesthetic, after injection of spinal anesthetic, before incision of the abdomen, before incision of the uterus, after delivery
Method of measurement
manometer
2
Description
mother's heart rate during cesarean section
Timepoint
mother's heart rate blood pressure in the following moments: before injection of spinal anesthetic, before starting the surgery, before the uterus incision, after delivery
Method of measurement
heart monitor
3
Description
amount of mother's nausea during surgery
Timepoint
once during the surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
newborn's APGAR scale
Timepoint
the 3rd and 5th minute after delivery of the baby
Method of measurement
APGAR scale
Intervention groups
1
Description
Intervention group: the group that receives manual left tilting of the uterus, anesthesiologist stands on the right side of the patients and presses the highest border of the uterus to the left during the surgery until fetus delivery. maternal blood pressure and pulse rate will monitor continuously and register 5 times.
Category
Prevention
2
Description
Control group: the group that goes through the conventional cesarean section without tilting of the uterus,In this group we won't do any intervention on the uterus during cesarean section and only record vital signs.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Ehsan Bastan Hagh
Street address
Yas Hospital, North Nejatollahi St, Kharim Khan Ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Fax
+98 21 8894 8217
Email
e-bastanhagh@sina.tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Ali Sahraian
Street address
6th floor, main university building, next to Qods st, keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
deanmed@tums.ac.ir
Web page address
http://crepi.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Bastan-Hagh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yas Hospital, North Nejatollahi St, Kharim Khan Ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
drbastanhagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Bastan-Hagh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yas Hospital, North Nejatollahi St, Kharim Khan Ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
drbastanhagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Amirmohammadi
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 5, Farhat alley, Namjoo Ave
City
Tehran
Province
Tehran
Postal code
1615938513
Phone
+98 21 7757 4159
Fax
Email
m-amirmohammadi@student.tums.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