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CTRI Number  CTRI/2024/06/068502 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
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 giving spinal anaesthesia in pregnant woman with high blood pressure and pregnant woman with normal blood pressure who are undergoing cesarean section. 
Scientific Title of Study   Comparison of the Haemodynamic Changes in Normotensive and Preeclamptic Pregnant Woman Posted for Cesarean Section Under Subarachnoid Block- Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun 
Designation  Junior resident in department of anaesthesiology and critical care 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  8088822666  
Fax    
Email  arunv5656@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyothsna M 
Designation  Professor 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9900055996  
Fax    
Email  jyothsnabk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyothsna M 
Designation  Professor 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anaesthesiology, Vijayanagar institute of medical sciences, cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9900055996  
Fax    
Email  jyothsnabk@yahoo.com  
 
Source of Monetary or Material Support  
Vijayanagar institute of medical sciences, Ballari 
 
Primary Sponsor  
Name  Vijayanagar institute of medical sciences 
Address  Vijayanagar institute of medical sciences, Cantonment, Ballari - 583104, Karnataka, India 
Type of Sponsor  Government medical college 
 
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 
Dr Arun  Vijayanagar institute of medical sciences  Room no. 99, Department of obstetrics and gynaecology, emergency operation theatre Bellary
Bellary
KARNATAKA 
8088822666

arunv5656@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagar institute of medical sciences,Ballari, Institutional ethics committee,VIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant patients belonging to ASA 2 and 3 status, Patients scheduled for LSCS with normotensives or preeclampsia. 
 
ExclusionCriteria 
Details  Patient refusal for spinal anaesthesia, history of allergy to drugs, any contraindications for spinal anaesthesia, pre-diagnosed eclampsia, HELLP syndrome, severe fetal distress, cord prolapse, twin pregnancy, antepartum hemorrhage, morbid obesity, pre-diagnosed chronic hypertension, diabetes mellitus, known cardiac disease, renal disease and coagulopathy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypotension  After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
Grades of hypotension, Use of vasopressors, Use of oxytocis, Intravenous fluid requirement,Amount of blood loss  After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure.
After skin incision the blood loss shall be estimated till the end of surgery.
intra operative total dose of oxytocis used. 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   15/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This study will be conducted on  pregnant woman of ASA physical II (Normotensive) or III Preeclamptic(hypertension to the extent of 140/90mmhg or more in two occasions 6hours apart with proteinuria(more than 300 mg/24hours) after 20th week of pregnancy in previously normotensive or non-protienuric patients), , carrying a live, mature, healthy, single fetus scheduled for cesarean section under SAB. Patients will be counselled during preoperative examination  and will be recruited for this study after obtaining informed consent from each of the patient in their own language. Patients with chronic hypertension, diabetes mellitus, known cardiac disease, renal disease, and coagulopathy; with contraindication to subarachnoid block, known sensitivity to the study drugs and patients refusing to either regional anesthesia or the study technique will also be excluded from the study. Any patients showing signs or alarming symptoms for eclampsia will be excluded from the study and managed with IV MgSO4 wherever indicated. All antihypertensives will be continued till the day of surgery. After receiving the patient in the operating room, documents will be checked, a brief clinical examination will be done and standard ASA monitors will be attached including ECG, pulse oximetry and temperature probe.  Baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be recorded. After establishing IV access with an 18G cannula 20 ml/kg lactated ringer solution (RL) will be administered for prehydration. After proper aseptic precaution spinal subarachnoid block (SAB) will be performed by an anesthesiologist, at L3-L4 intervertebral space through a midline approach. Surgery will be allowed after adequate sensory and motor block confirmed (T6 level). Immediately after delivery of head of the baby oxytocin 5 IU will be administered over 1 minute followed by infusion at the rate of 5 IU/H for 2 hours. Intraoperative blood loss of the mother will be assessed from the drainage in suction bottles and checking the swabs and mops used, clots and appropriate replacement done. HR, SBP, DBP and MAP will be recorded every 2minutes for first 15minutes and every 5mintes after that throughout the procedure.  The data will be labeled as group N for normotensives and group P for pre-eclamptics and will be analyzed.

 
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