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CTRI Number  CTRI/2025/07/090764 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing a decrease in systolic versus mean arterial blood pressure for effect on well-being of babies born by cesarean delivery conducted under spinal anaesthesia. 
Scientific Title of Study   Postspinal Hypotension In Patients Of Preeclampsia: Randomised Comparison Of Equivalent Fall In Systolic Versus Mean Arterial Pressure For Effect On Neonatal Outcome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ASHA TYAGI 
Designation  Director Professor 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital 
Address  Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone  01122692415  
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ASHA TYAGI 
Designation  Director Professor 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital 
Address  Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone  01122692415  
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta 
Designation  Postgraduate Resident 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone  9996537541  
Fax    
Email  shwetagiroh66@gmail.com  
 
Source of Monetary or Material Support  
University college of Medical Sciences and GTB Hospital, Dilshad Garden, Shahdra, Delhi-110095. 
 
Primary Sponsor  
Name  University College Of Medical Sciences and Guru Teg Bahadur Hospital 
Address  Dilshad Garden, Shahadra, Delhi 110095 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHWETA  University College of Medical Sciences and GTB Hospital  2nd floor, OT block, Department of Anaesthesiology and Critical Care, Dilshad garden, Delhi.
East
DELHI 
09996537541

shwetagiroh66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Human Research, (IED-HR), UCMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O14||Pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group M20: Postspinal hypotension defined as 20% or more fall in Mean blood pressure.  Will be treated with boluses of vasopressor till blood pressure rises above the hypotensive threshold defined for group M20 (anytime from completion of spinal block upto delivery of baby). 
Intervention  Group S20: Postspinal hypotension defined as 20% or more fall in systolic blood pressure  Will be treated with boluses of vasopressor till blood pressure rises above the hypotensive threshold defined for group S20 (anytime from completion of spinal block upto delivery of baby). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Consenting women with preeclampsia scheduled for cesarean section under spinal anesthesia 
 
ExclusionCriteria 
Details  Those known with chronic hypertension and other cardaic vascular disease, cerebro vascular disease, known fetal abnormalities or any contraindications to spinal block  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Umbilical artery pH   At the time when baby is delivered (by cesarean section). 
 
Secondary Outcome  
Outcome  TimePoints 
Neonatal umbilical artery base excess  At the time when baby is delivered (by cesarean section).  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The present study thus aims to compare two equivalent falls in systolic and mean arterial pressure for defining (and concomitantly treating) postspinal hypotension in patients of preeclampsia undergoing cesarean section, with regards to neonatal and maternal outcome. 

Primary objective is to compare postspinal hypotension defined as  20% or more fall in systolic blood pressure or in mean arterial pressure, in patients of preeclampsia undergoing cesarean section with regards to umbilical artery pH.

Methods

The anesthetic management for these patients will be standardized as per routine practice. This will include standardized aspiration prophylaxis, non-invasive monitoring and single-shot spinal block using hyperbaric bupivacaine.

Systolic, diastolic and mean arterial pressures as well as heart rate will be measured every minute from the spinal injection until delivery of the baby. Hypotension after spinal anesthesia will be defined as a decrease in systolic arterial pressure of 20% or more from baseline for group S20; and similar fall in mean arterial pressure for group M20. Whenever postspinal hypotension occurs it will be treated with 50 microgm of phenylephrine (i.v.), repeated every minute, till the blood pressure rises above the hypotensive threshold. 

Statistical analysis will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Intergroup comparison will be done with Pearson’s Chi-square, Fisher’s exact test or Mann–Whitney U-test t-teat as appropriate, after testing for normal distribution using K-S test. Intergroup trends of arterial pressure and heart rate for the study period will be analyzed using mixed-model analysis, taking the best covariance structure based on Akaike’s information criterion (AIC). 

 
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