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CTRI Number  CTRI/2021/10/037475 [Registered on: 22/10/2021] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE 
Study Design  Single Arm Study 
Public Title of Study   Does the drop in mothers blood pressure after spinal anaesthesia affect the baby. 
Scientific Title of Study   TO STUDY THE EFFECT OF MATERNAL BLOOD PRESSURE CHANGES DURING SPINAL ANAESTHESIA IN PATIENTS UNDERGOING ELECTIVE CESAREAN SECTION, ON SHORT TERM NEONATAL OUTCOMES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHARMILA RAJKUMARI A 
Designation  PG REGISTRAR 
Affiliation  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, VELLORE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, CHRISTIAN MEDICAL COLLEGE VELLORE

Vellore
TAMIL NADU
632004
India 
Phone  8508636774  
Fax    
Email  asharmilarajkumari@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Shirley 
Designation  Professor 
Affiliation  Christian medical college and hospital vellore  
Address  Department of Anaesthesia Christian medical college and hospital Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7358377164  
Fax    
Email  anjeyanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHARMILA RAJKUMARI A 
Designation  PG REGISTRAR 
Affiliation  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL, VELLORE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, CHRISTIAN MEDICAL COLLEGE VELLORE


TAMIL NADU
632004
India 
Phone  8508636774  
Fax    
Email  asharmilarajkumari@yahoo.com  
 
Source of Monetary or Material Support  
INTERNAL FLUID RESEARCH FUND, CHRISTIAN MEDICAL COLLEGE, VELLORE. 
 
Primary Sponsor  
Name  Christian medical college vellore  
Address  Christian medical college and hospital,vellore ,632004 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL  Institutional Review Board (IRB), Bagayam campus,Office of Research, 1st Floor, Carman Block, Bagayam, Vellore 632 002, India. E-mail: research@cmcvellore.ac.in. Tel: 0416 -2284294  
DR ANITA SHIRLEY  Department of Anaesthesia, Christian Medical College, Vellore, 632004 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHARMILA RAJKUMARI A  Centenary Block, Operation room 5,6,7  Department of Anaesthesia, Christian Medical College and Hospital, Vellore ,632004
Vellore
TAMIL NADU 		 8508636774

asharmilarajkumari@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee,Institutional review board, Christian Medical College,Vellore..  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  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  All parturients at term gestational age with no antenatal risk factors undergoing elective caesarean section planned under Spinal anaesthesia and their neonates . 
 
ExclusionCriteria 
Details  1. Not willing to participate in the study.
2. Emergency LSCS
3. Antenatal risk factors –PIH, preeclampsia, eclampsia, GDM ,APH . Multiple pregnancy.
4. Fetal risk factors like - Any history of IUGR, Congenital Anomalies, Short for gestational age for this baby.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effect of maternal blood pressure change no hypotension less than 20 per cent from baseline ,mild 20 to 30 percent from baseline and moderate 30 to 40 percent fall from baseline , Severe more than 40 percent from baseline, during Spinal Anaesthesia on the neonate is assessed by the umbilical artery cord blood pH and base deficit , Apgar score of the neonate at 1min, 5 mins and 10mins & the need for nursery admission . The Fetal acidosis is considered as umbilical arterial cord blood pH of less than 7.2.The ABG has to be analysed within 30 minutes . With these datas we can conclude the primary objective of whether this affects the neonatal outcomes or not.   Blood pressure is measured every 1 minute till the delivery of the baby and then every 3 mins .
2 The ABG is done within 30 minutes.
3 The Apgar is measured in 1 minute, 3 minutes and 5 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Incidence of hypotension more than 20 percent drop in Systolic Blood Pressure from the baseline among parturients undergoing elective LSCS under spinal anaesthesia.
2 To correlate the severity of hypotension ,mild , moderate, severe, with the neonatal outcomes
3 To determine the effect of the duration of hypotension, number of vasopressor boluses administered , anaesthesia incision delivery time on neonatal outcomes.
 		 1 year 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2021 
Date of Study Completion (India) 31/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Will be published in national and international journals. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Hypotension is the commonest complication of spinal anaesthesia . This hypotension in parturients undergoing elective cesarean section under spinal anaesthesia is associated with reduced uteroplacental perfusion , if not treated immediately can lead to neonatal acidemia .But the term neonates tolerated this acidosis . The incidence of hypotension under spinal anaesthesia was more than 50% . It was found that those parturients who hypotensed (58.2%)  had 9.2% babies with acidosis and those who were normotensive (41.8%) had 0.5% babies with acidosis. Since there were very few prospective studies and few indian studies on this topic , i would like to observe the change in the hypotension (<20% - normotensive , 20-30%-mild hypotensive, 30-40%-moderate hypotensive, >40% severe hypotension) ,and their efffect on the neonate which is measured using three parameters- umbilical cord blood ABG, Apgar scores at 1 minute, 5 minutes, 10 minutes,  the rate of nursery admission decided by neonatalogist. Other factors causing neonatal acidosis like Anaesthesia -incision-delivery time and boluses of ephedrine will be observed as secondary objective. Hence , the main purpose of my study is to observe ,whether the changes in the maternal blood pressure under spinal anaesthesia  in parturients undergoing elective cesarean section has any effect on short term neonatal outcomes. 
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