Determining the effect of prescribing fluids containing sugar on blood pressure and heart rate of a mother undergoing cesarean section
Design
Randomized clinical trial using closed-door envelope with control group, with parallel groups, double-blind, phase 3-2 on 60 patients
Settings and conduct
This study will be performed on pregnant women who are candidates for cesarean section (more than 37 weeks) who referred to Ghaem Hospital in Mashhad. The study was double-blind and participants and outcome analyzers would not know how to group.
Participants/Inclusion and exclusion criteria
Monozygotic and full-term pregnancies that are candidates for cesarean section and no diabetes and cardiovascular disease and no fetal abnormalities
Intervention groups
In this study, Full term pregnan tmothers who are candidates for cesarean section before performing spinal anesthesia in the control group as a placebo of getting intravenous normal saline and in the intervention group intravenous normal saline containing 1% glucose (10 g per 1000 cc) 5 to 7 cc is infused based on weight in 15 to 20 minutes
Main outcome variables
Blood pressure, Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220417054563N1
Registration date:2022-04-24, 1401/02/04
Registration timing:prospective
Last update:2022-04-24, 1401/02/04
Update count:0
Registration date
2022-04-24, 1401/02/04
Registrant information
Name
Samira Saghravanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 9284
Email address
saghravaniannsamiraa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-23, 1401/03/02
Expected recruitment end date
2023-02-21, 1401/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of glucose-containing fluids on Hemodynamic changes after Spinal Anesthesia for cesarean section
Public title
The effect of sugary fluids on cesarean mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to enter the study
Monozygotic pregnancy
Cesarean section candidate
Exclusion criteria:
Diabetes
Cardiovascular and cerebral disease
Excessive bleeding and the need for blood transfusions
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each closed envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects and those evaluating the outcome will be unaware of the intervention and control groups. Written consent is obtained from patients, but at the same time patients do not know whether they are in the placebo or intervention group, the researcher evaluating the outcome does not know which group the patients are in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2022-02-05, 1400/11/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.021
Health conditions studied
1
Description of health condition studied
Term pregnant women who are candidates for cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Blood pressure
Timepoint
During surgery (Before spinal; 5 and 10 minutes after spinal and end of operation)
Method of measurement
Automatic barometer
2
Description
Heart rate
Timepoint
During surgery (Before spinal; 5 and 10 minutes after spinal and end of operation)
Method of measurement
Electrocardiogram
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this study, Full term pregnant mothers who are candidates for cesarean section, 5 to 7 cc of venous normal saline is infused in 15 to 20 minutes based on weight before spinal anesthesia.
Category
Placebo
2
Description
Intervention group: In this study, Full term pregnant mothers who are candidates for cesarean section, before performing spinal anesthesia, intravenous normal saline containing 1% glucose (10 g per 1000 cc) is infused 5 to 7 cc based on weight in 15 to 20 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Masoomeh Tabari
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
Tabarim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoomeh Tabari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
tabarim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoomeh Tabari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
tabarim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoomeh Tabari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
tabatim@mums.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