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CTRI Number  CTRI/2024/08/073061 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Preventing hypotension induced by oxytocin in elective cesarean section by two different doses of phenylephrine. 
Scientific Title of Study   Haemodynamic effect of two different doses of phenylephrine in preventing oxytocin induced hypotension in elective caesarean section-A Randomised control trial.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KavyaG 
Designation  Post graduate  
Affiliation  Sri Venkateshwar medical college hospital and research centre 
Address  Department of Anaesthesialogy and critical care.sri Venkateshwaraa medical college hospital and research center No.13-A,pondy-villupuram main road, Ariyur,Pondicherry
Department of Anaesthesialogy and critical care.sri Venkateshwaraa medical college hospital and research center No.13-A,pondy-villupuram main road, Ariyur,Pondicherry
Pondicherry
PONDICHERRY
605107
India 
Phone  9952905538  
Fax    
Email  Kavyaganesh2468@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Radhakrishnan 
Designation  Professor  
Affiliation  Sri Venkateshwaraa medical college hospital and research center  
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college hospital and research center No.13-A, pondy-villupuram main road, Ariyur

Pondicherry
PONDICHERRY
605107
India 
Phone  8825778958  
Fax    
Email  rkpuduvai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Radhakrishnan 
Designation  Professor  
Affiliation  Sri Venkateshwaraa medical college hospital and research center  
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college hospital and research center No.13-A, pondy-villupuram main road, Ariyur

Pondicherry
PONDICHERRY
605107
India 
Phone  8825778958  
Fax    
Email  rkpuduvai@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college hospital and research centre,No-13-A,Pondy-Villupuram main road , Ariyur ,Puducherry , India,602103  
 
Primary Sponsor  
Name  Kavya G 
Address  Sri Venkateshwaraa medical college hospital and research center No.13-A, pondy-villupuram main road, Ariyur, Puducherry, India, 605102 
Type of Sponsor  Other [Self] 
 
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 
DrKavya G  Sri Venkateshwaraa medical college hospital and research center   Department of Anaesthesia, ot complex, room no.1,pondy-villupuram main road, Ariyur, Puducherry
Pondicherry
PONDICHERRY 		 9952905538

Kavyaganesh2468@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous phenylephrine 100 micrograms   Group-B patients will receive oxytocin 3IU and phenylephrine 100 micrograms diluted to 10 cc with normal saline as an infusion over 10 mins 
Intervention  intravenous phenylephrine 75 micrograms   Group-A Patients will receive oxytocin 3 IU and phenylephrine 75 micrograms diluted to 10cc with normal saline as an infusion over 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  American society of Anaesthesialogy class 2 ,Patients of female sex age from 18 to 40 years undergoing elective cesarean section. 
 
ExclusionCriteria 
Details  Prolonged labour,Ruptured amniotic membrane,Maternal complications(multiple Pregnancy,pre-eclampsia, cerebrovascular disease,abnormal placenta,uterine fibroid),patients with contraindications to spinal Anaesthesia, Hypovolemia due to any cause. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of co-administration of oxytocin with phenylephrine,  2mins,5mins,10mins,10mins,20mins,30mins,40mins,50mins,1hr,2hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Need for rescue vasopressors and incidence of side effects  2mins,5mins,10mins,10mins,20mins,30mins,40mins,50mins,1hr,2hrs,3hrs,4hrs,5hrs,6hrs,12hrs,24hrs. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/09/2024 
Date of Study Completion (India) 20/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Kavyaganesh2468@gmail.com].

  6. For how long will this data be available start date provided 24-07-2024 and end date provided 24-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is to compare two different doses of 75 mcg and 100 mcg of  Phenylephrine in preventing oxytocin induced hypotension in elective cesarean sections. My study hypothesis is  that low dose of Phenylephrine is adequate to maintain the hemodynamic changes caused by oxytocin and to prevent further hemodynamic  changes in elective cesarean sections. 
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