A randomized controlled investigation of crystalloid preloading and co-loading for the avoidance of spinal block-related low blood pressure in parturients undergoing cesarean section
The aim of this study is to compare the effectiveness of crystalloid preloading versus crystalloid coloading in reducing the incidence and severity of spinal anesthesia-induced hypotension among women undergoing cesarean section under spinal anesthesia
Design
Randomised, parallel group trial, sample size of 120. Randomisation was 1:1 ratio
Settings and conduct
The study will be conducted as a single-center randomized controlled trial.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Term pregnancy (≥37 completed weeks of gestation).
Scheduled for cesarean section under spinal anesthesia.
Baseline hemodynamically stable before spinal anesthesia.
Able to provide written informed consent to participate in the study.
exclusion criteria:
Patient refusal or inability to provide informed consent.
Contraindication to spinal anesthesia or planned general anesthesia.
Significant renal disease or impaired renal function.
Patients receiving significant intravenous fluid resuscitation before randomization
Emergency cesarean section requiring immediate general anesthesia.
Intervention groups
Crystalloid Preloading:
Participants will receive intravenous crystalloid solution as a preload before administration of spinal anesthesia. The specified volume and timing will be according to the study protocol.
Crystalloid Coloading:
Participants will receive intravenous crystalloid solution as a coload, initiated at the time of administration of spinal anesthesia. The specified volume and timing will be according to the study protocol
Main outcome variables
participants developing hypotension after cesarian will be compared between the crystalloid preloading and coloading groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260818070708N1
Registration date:2026-08-25, 1405/06/03
Registration timing:prospective
Last update:2026-08-25, 1405/06/03
Update count:0
Registration date
2026-08-25, 1405/06/03
Registrant information
Name
Faiza shabbir
Name of organization / entity
Lady reading hospital
Country
Pakistan
Phone
+92 333 9136480
Email address
khurramyounas17@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-09, 1405/07/17
Expected recruitment end date
2026-12-10, 1405/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled investigation of crystalloid preloading and co-loading for the avoidance of spinal block-related low blood pressure in parturients undergoing cesarean section
Public title
avoidance of low blood pressure in pregnant women going through cessarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnancy (≥37 completed weeks of gestation)
Scheduled for cesarean section under spinal anesthesia
Baseline hemodynamically stable before spinal anesthesia.
Able to provide written informed consent to participate in the study
Exclusion criteria:
Patient refusal or inability to provide informed consent
Contraindication to spinal anesthesia or planned general anesthesia.
Emergency cesarean section requiring immediate general anesthesia
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomized individually in a 1:1 ratio to the crystalloid preloading or crystalloid co-loading group using computer-generated permuted block randomization with variable block sizes of 4 and 6. A random allocation sequence will be generated before commencement of participant recruitment. Sequentially numbered, opaque, sealed envelopes containing the group assignments will be prepared according to the randomization sequence. After confirmation of eligibility and obtaining informed consent, the next sequential envelope will be opened to determine the participant's allocation. Allocation concealment will be maintained until the time of assignment. No stratification will be used..
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
Lady reading hospital Institutional review board
Street address
Lady reading hospital, near balahisar fort, Peshawar, Pakistan
City
Peshawar
Postal code
25000
Approval date
2025-05-19, 1404/02/29
Ethics committee reference number
202/LRH/MTI
Health conditions studied
1
Description of health condition studied
TO AVOID LOW BLOOD PRESSURE IN PATIENT AFTER CESAREAN SECTION
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
stable normal blood pressure
Timepoint
Intraoperative period (from spinal anesthesia until 30 minutes after spinal anesthesia).
Method of measurement
sphygmomonomete
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Crystalloid coloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously immediately after initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes. The infusion will be initiated immediately after spinal anesthesia and continued for 20 minutes, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration.
Category
Treatment - Other
2
Description
Control group: Crystalloid preloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously 20 minutes before initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes using an intravenous infusion, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Lady reading hospital
Full name of responsible person
Roheena Wadud
Street address
Lady reading hospital, near balahisar fort, Peshawar, Pakistan
City
Peshawar
Postal code
25000
Phone
+92 345 9192727
Email
khurranyounas17@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lady reading hospital
Full name of responsible person
Roheena Wadud
Street address
Lady reading hospital, near balahisar fort, Peshawar, Pakistan
City
Peshawar
Postal code
25000
Phone
+92 91 9211430
Email
roheena.wadud@lrh.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lady reading hospital
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
lady reading hospital
Full name of responsible person
Faiza Shabbir
Position
trainee medical officer
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
lady reading hospital, near balahisar fort, peshawar, pakistan
City
peshawar
Province
Kpk
Postal code
25000
Phone
+92 345 9192727
Email
khurramyounas17@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lady reading hospital
Full name of responsible person
Faiza Shabbir
Position
Trainee medical officer / resident doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Seithi bangla, seithi town, haji camp, peshawar
City
Peshawar
Province
Kpk
Postal code
25000
Phone
+92 345 9192727
Fax
Email
khurramyounas17@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Lady reading hospital
Full name of responsible person
Faiza Shabbir
Position
Trainee medical officer / resident doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Seithi bangla, seithi town, haji camp, peshawar
City
Peshawar
Province
Kpk
Postal code
25000
Phone
+92 345 9192727
Fax
Email
khurramyounas17@yahoo.com
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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Data and documents may be used for legitimate scientific and academic research purposes, subject to applicable ethical requirements, institutional policies, and protection of participant confidentiality
From where data/document is obtainable
The requested documents will be obtainable from the principal investigator upon reasonable request.
What processes are involved for a request to access data/document
Requests may be submitted by email to the contact person listed in the IRCT registration and will be considered subject to applicable ethical, institutional, and confidentiality requirements