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CTRI Number  CTRI/2024/04/065640 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 11/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of Mother,Height weight,fetal and newborn weight on the effect of post spinal Anaesthesia decrease blood pressure 
Scientific Title of Study   Effect of Maternal BMI Fetal & newborn weight on the incidence of post spinal anaesthesia hypotension in full term Parturients undergoing elective caeserean section: A 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 Aarti Agarwal  
Designation  Additional professor 
Affiliation  SGPGIMS LUCKNOW 
Address  Department of anaesthesiology room no 4 1st Floor A Block Sajay Gandhi Post Graduate Institute Of Mediacal Science Lucknow
Raebarely Road Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India 
Phone  8765974039  
Fax    
Email  aarti_agarwal000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti agarwal  
Designation  Additional professor 
Affiliation  SGPGIMS LUCKNOW 
Address  Department of Anaesthesiology Roomno - 4 1st floor A block SGPGIMS LUCKNOW Uttar Pradesh
Raebareli Road Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India 
Phone  8765974039  
Fax    
Email  aarti_agarwal000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Kumar 
Designation  Junior resident 
Affiliation  SGPGIMS LUCKNOW 
Address  SGPGIMS hostel room no -706 seventh floor M1 Block LUCKNOW
Raiberily Road Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India 
Phone  993610637  
Fax    
Email  anil.medico48@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute Of Medical Science, Lucknow 
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute Of Medical Science  
Address  Raeberily Road Lucknow Uttar Pradesh Pin Code- 226014 
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 
DR Aaarti Agarwal  Sanjay Gandhi Postgraduate Institute Of Medical Science Medical Science Lucknow   Department Of Anaesthesiology 1st Floor Block A Room No- 15
Lucknow
UTTAR PRADESH 
8765974039

aarti_agarwal000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SGPGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  American Society of Anaesthesiologists status II

Women of child bearing age Below 40year

BMI less than 40

Height between 150-180 cm

Non-laboring

At term with singleton uncomplicated pregnancies

With no gross comorbidities

With longitudinal lie scheduled for elective caesarean delivery under spinal
anaesthesia 
 
ExclusionCriteria 
Details  Patient’s refusal for regional
anaesthesia
Women with obstetric conditions that may affect the severity of Aorto Caval compression, such as transverse lie, fetal macrosomia, uterine abnormalities (e.g.,large fibroids, bicornuate uterus) and polyhydramnios

Women with a hypertensive disorder or any condition associated with autonomic
neuropathy (e.g., diabetes mellitus for than 10 yrs), with renal failure, or currently
smoking or with illicit drug use

Those with kyphosis and scoliosis

Sepsis at the site of the injection

Indeterminate neurological disease

Coagulopathy

Increased intracranial pressure

History of allergy to local anaesthetics

Discopathy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the effect of maternal BMI,Fetal & Newborn weight on the incidence of post spinal anaesthesia hypotension in full term parturients undergoing elective ceasarean section   Systolic and Diastolic Blood
Pressure recorded ,After spinal anaesthesia to til delivery  
 
Secondary Outcome  
Outcome  TimePoints 
Effect on Mean phenylephrine consumption

Umbilical cord blood ph & base excess  
After spinal anaesthesia to till delivery

After clamp of umlical cord 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   22/04/2024 
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 Yet Recruiting 
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  

Spinal anesthesia is well tolerated , it still is associated with considerable side effect ,most common being hypotension due to sympatholysis , is occurring in upto 75% of cases,potentially endangerous to both mother and fetus. Spinal block leads to sympatholysis ,may leads to vasodialation and consequentally cause maternal hypotension , which compromise uterine blood flow and fetal circulation and cause fetal hypoxia ,bradycardia and acidosis. Incidence of hypotension in genral population 25-75% and even higher in parturient due to physiological change in pregnancy that cause compression in inferior venae cava by hypertrophic uterus and also due to collateral venous plexus in epidural space , the physiological change in epidural space result in increase pressure of cerebrospinal fluid in lumbosacral area which result in cephalod spread of local anaesthestics these case rapid onset of sympatholysis due to increase sensitivity of nerve fiber to local anaesthetics during pregnancy . Higher sensitivity of nerve fiber towards local anaesthetics and aorto cavel compression of pregnant ueterus ,are rthe main reason for the increase incidence and higher level of hypotension in pregnant women as compare to non pregnant women, Pregnant women have increase sympathetic activity as compare to parasympathetic , then sympatholytic activity may leads to higher degree of vasodialatation ,consequntally decrease venous return , cardiac preload , bradycardia nausea and vomiting in mother The Duration of hypotension play importance role than its severity , hypotension <2 minute didn,t affect neurodevlopment outcome , whereas maternal hypotension lasting >4 minute neurodevlopment in first week of life and may persist through life long. A Number of measurement and treatment are use in clinicle practice in spinal anasthesia induce hypotension as – -Preloading and coloading with colloid -Compressing of lower limb with compression stocking or bandage -Administration of optimal dose of local anasthetics -left tilt positioning - adminastration of ionotrops and vessopressure, phenylephrine is preferred which associated with lower incidence of fetal acidemia ,nausea and vomiting Thus identification of multifactor of spinal anasthesia induce hypotension. Might help to prevent them dramatic consequnces in mother and fetus. Thus through this study we observe the effect of maternal BMI fetal and newborn weight on hypotension by observe 100 sample patient 12 month in pmssy building sgpgi lucknow. After ethical comettie approval and CTRI registration.

 
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