Comparison of the effect of Ringer Lactate versus Sodium Chloride 0.9% on maternal and neonatal acid- base state in elective cesarean delivery
Design
A prospective randomized controlled trial (RCT), community-based, with two parallel groups, double blinded, randomized, consisted of 48 pregnant women in two groups of 24
Settings and conduct
In this study, which will be performed in the obstetric operating room of Alzahra Hospital in Tabriz in 98, the effect of two types of serums Ringer lactate and sodium chloride 0.9% on the maternal and neonatal acid-base status on 48 paturients will be compared. They randomly devided into two groups. All data from the study will be collected through a checklist. Anesthesiologist who collects the data and pregnant women undergoing cesarean section are also unaware of the division of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 48 term pregnant women with the physical status of the ASA Class I or II, aged 18 to 45 years old, candidate for elective cesarean with spinal anesthesia with informed consent.
Exclusion criteria: Any contraindication of regional anesthesia, maternal concurrent disease, emergency cesarean
Intervention groups
In the Ringer lactate group (n = 24), during the cesarean section, the Ringer lactate serum and in the sodium chloride 0.9% (n = 24) sodium sodium chloride 0.9% will be infused to the mother.
Main outcome variables
maternal and neonatal acid-base status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180411039267N2
Registration date:2019-06-19, 1398/03/29
Registration timing:registered_while_recruiting
Last update:2019-06-19, 1398/03/29
Update count:0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Reyhaneh Abri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3476 7121
Email address
re.abri@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of Ringer Lactate versus Sodium Chloride 0.9% on maternal and neonatal acid- base state in elective cesarean delivery
Public title
A comparison of the effect of Ringer Lactate versus Sodium Chloride 0.9% on maternal and neonatal acid- base state in cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term parturient (pregnancy age more than 37 weeks)
with physical status II ASA class
candidates for elective cesarean section with spinal anesthesia
Age range 18 to 45 years old
In Tabriz Alzahra hospital
Informed consent
Exclusion criteria:
Any contraindication of regional anesthesia
Gestational hypertension, preeclampsia, eclampsia, HELLP syndrome
Hypersensitivity to local anesthetics
Morbid obesity
Maternal co-existing disease such as a history of heart disease, pulmonary, liver and kidney disease
Emergency cesarean section like fetal bradycardia, placenta previa or other conditions of peripartum hemorrhage
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table, they will be randomly divided into two groups of 24 people in the study and 24 people in the control group. In such a way that in the event of odd, they would be in Ringer Lactate and in the event of even, they would be in Sodium Chloride 0.9% group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The administration of anesthesia and fluids (volume and type of serum) during anesthesia is performed by an anesthesiologist and anesthesia technician, and all data will be collected and recorded in the checklist by an anesthesiologist who is unaware of the division of the groups. Pregnant women undergoing cesarean section are also unaware of the division of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Department of Anesthesiology, Alzahra hospital, South artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5174815811
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.TBZMED.REC.1397.034
Health conditions studied
1
Description of health condition studied
Intraoperative fluid therapy, maternal and neonatal acid- base state, elective cesarean delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
maternal acid- base state during elective cesarean
Timepoint
In operating room before the spinal anesthesia and after surgery (in recovery), an arterial blood sample will be analyzed for arterial blood gases (ABG).
Method of measurement
In the ABG sample, the factors PH, HCO3, Base Excess, PCO2, Po2, Hb, Hct will be analyzed and will be recorded in the checklist for this purpose.
Secondary outcomes
1
Description
neonatal acid- base state during elective cesarean
Timepoint
Immediately after delivery and the umbilical cord closure, an umbilical artery blood sample will be sent for analysis of arterial blood gas (ABG).
Method of measurement
In the ABG sample, the factors PH, HCO3, Base Excess, PCO2, Po2, Hb, Hct will be analyzed and will be recorded in the checklist for this purpose.
Intervention groups
1
Description
Intervention group: In 24 pregnant women, infusion of lactate ringer serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward.
Category
Treatment - Other
2
Description
Control group: In 24 pregnant women, infusion of Sodium Chloride 0.9% serum with dose of volume therapy rule(Deficit+ Maintenance+ Loss+ Third space+ Compensated volume expansion) will begin before surgery and will continue until delivery of mother to the ward.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Reyhaneh Abri
Street address
Alzahra hospital, South artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9163
Email
alzahrahosp@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra Hospital, South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5174815811
Phone
+98 41 3553 9163
Email
reyhane.abri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Email
reyhane.abri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Abri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating room-alzahra hospital- south artesh st
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3476 7121
Email
reyhane.abri@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