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CTRI Number  CTRI/2022/06/043517 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 03/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To compare the occurrence of fall in blood pressure after spinal anaesthesia among normal pregnant women and pre-eclamptic women who are undergoing cesarean section  
Scientific Title of Study   Comparison of incidence of spinal anaesthesia induced hypotension between patients with severe preeclampsia and low risk pregnant women undergoing emergency caesarean delivery: a prospective cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aswini Kuberan 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Dept. of Anaesthesia JIPMER
JIPMER Gorimedu, Dhanvanthari Nagar Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9914017949  
Fax    
Email  ashdoctor.kuberan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Varun Nair 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Dept.of Anaesthesia JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  6282124558  
Fax    
Email  varunloyolite@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varun Nair 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Dept.of Anaesthesia JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  6282124558  
Fax    
Email  varunloyolite@gmail.com  
 
Source of Monetary or Material Support  
JIPMER, Puducherry 
 
Primary Sponsor  
Name  JIPMER 
Address  Dean research, JIPMER Dhanvanthari Nagar Gorimedu Puducherry D 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Varun B Nair  JIPMER  Dept. of anaesthesia
Pondicherry
PONDICHERRY 
6282124558

varunloyolite@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Observational Studies DHR REG. N0. EC/NEW/INST/2020/331  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  (Group 1)
Women with severe preeclampsia undergoing emergency caesarean section under spinal anaesthesia.

(Group 2)
Low risk pregnant women undergoing emergency caesarean section under spinal anaesthesia

 
 
ExclusionCriteria 
Details  1.NICE 1 planned for General anaesthesia
2.Patients who received labour analgesia planned for LSCS

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of post spinal hypotension in both the groups. ( 20 % reduction in the baseline MAP) w678  Every minute until 20 minutes after spinal anaesthesia administration 
 
Secondary Outcome  
Outcome  TimePoints 
1) Comparison of total dose of vasopressors used in managing post spinal hypotension between two groups.

2) Comparison of serum magnesium, serum uric acid, serum endothelin 1(ET I) and urine norepinephrine (NE) to incidence of hypotension in severe pre-eclampsia.

3) Comparison of neonatal outcomes (Apgar score, cord blood pH estimation, base deficit and serum bicarbonates) between the groups
 
1) Intaoperatively when hypotension is noted

2) Pre-operative blood sample

3) End -opertive/immediately after child birth 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   30/06/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Problem statement: Historical belief regarding optimal anaesthetic technique for caesarean delivery in severe preeclamptic women was that spinal anaesthesia causes precipitous hypotension in severe pre-eclampsia patients due to rapid sympathetic blockade, contracted intravascular volume and limited fluid administration.. Later many clinical studies confirmed the safety of spinal anaesthesia in severe pre-eclampsia patients and recommended  lumbar neuraxial anaesthesia as the preferred mode of anaesthesia. The same authors observed the incidence of hypotension was less in severe pre eclamptic patients compared to that of normal pregnant women.. These authors speculated that higher sympathetic activity with high vascular tone, raised circulating factors with potent pressor activity and increased sensitivity to pressor drugs contributed to lesser degree of  hypotension. However, a multicentre study reported a higher incidence of hypotension is spinal anaesthesia compared to epidural anaesthesia3. Also fluid strategies used in the above studies are not consistent with the current practice of co-loading.

 

RationaleAlthough risk comparison trials in severe pre-eclampsia has reported less incidence of spinal anaesthesia induced hypotension , data supporting the same among the Indian population is lacking. Moreover, varied incidences of hypotension in severe pre-eclamptic patients have been reported (the incidence of hypotension documented in the study by Visalyaputra et al was 51% as opposed to 16.6% in the study conducted by Antoine G. M. Aya et al.) Also fluid management protocols used are not consistent with present practice. The studies have followed preloading of IV fluids preoperatively {1500-2000 ml of ringer lactate 500ml of 6% hydroxyethyl starch} as opposed to the current concept favouring co-loading of fluids. Due to these conflicting observations, we would like to observe and compare the incidence of post spinal hypotension between severe pre-eclamptic patients and low risk pregnant women undergoing emergency caesarean delivery.

 

Novelty: Varied incidence of hypotension in severe pre-eclampsia after spinal anaesthesia has been reported. The fluid management protocol used in the studies was also not consistent with the current practice. Furthermore, major studies had a population consisting of elective caesarean section and no study provided data neither on emergency caesarean sections exclusively nor on an Indian population.

Expected outcome and application: The expected outcome would be, whether the observation of low incidence of post-spinal hypotension made by previous studies is prevalent in our population of severe pre-eclamptic women undergoing emergency LSCS. 
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