| CTRI Number |
CTRI/2026/01/101473 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Immediate vs Delayed Lying-Flat Position After Spinal Anaesthesia in Mothers Having a Caesarean Section |
|
Scientific Title of Study
|
A Randomized Comparative Study of Immediate versus Delayed Supine Position on Maternal Hypotension during Caesarean Section at SMS Medical College Jaipur |
| 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 Savita Meena |
| Designation |
Associate professor |
| Affiliation |
Sawai Mansigh Medical College and Hospital Jaipur |
| Address |
Department of Anaesthesia Second floor OT Complex Dhanwantri building Sawai Man Singh Medical College and Hospital
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Meena |
| Designation |
Associate professor |
| Affiliation |
Sawai Mansigh Medical College and Hospital Jaipur |
| Address |
Department of Anaesthesia Second Floor OT Complex, Dhanwantri building Sawai Man Singh Medical College and Hospital
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290969216 |
| Fax |
|
| Email |
drsavita020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishan Kumar Meena |
| Designation |
Junior Resident |
| Affiliation |
Sawai Mansigh Medical College and Hospital Jaipur |
| Address |
Department of Anaesthesia Second floor OT Complex Dhanwantri building Sawai Man Singh Medical College and Hospital
Jaipur
RAJASTHAN
302004
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
7014953298 |
| Fax |
|
| Email |
Drkrish104meena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Second floor OT Complex Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital
Jaipur
RAJASTHAN
302004
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia,Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of Anaesthesia Second floor OT Complex Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital
Jaipur
RAJASTHAN
302004
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savita Meena |
Sawai Man Singh Medical College and Attached Hospital.jaipur |
Department of Anaesthesia Second floor OT Complex Dhanwantri
building, Sawai Man Singh Medical College and Attached Hospital.jaipur
302004
Jaipur
RAJASTHAN |
08290969216
drsavita020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of the ethics committee,sms medical college and attached hospitals,jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed Supine Position after Spinal Anaesthesia |
After administration of spinal anaesthesia for caesarean section the parturient will be maintained in 15 degree left lateral tilt for 5 minutes before shifting to the supine position with left uterine displacement. Standard monitoring will be continued. Blood pressure will be recorded at 1-minute intervals for the first 10 minutes and then every 3 minutes. Any episode of hypotension will be treated as per institutional protocol with vasopressors |
| Comparator Agent |
Immediate Supine Position after Spinal Anaesthesia |
After administration of spinal anaesthesia for caesarean section the parturient will be placed supine with 15 degree left uterine displacement immediately after completion of the intrathecal injection.
Standard monitoring and management protocols will be followed.
Blood pressure will be recorded every 1 minute for the first 10 minutes and every 3 minutes thereafter |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Scheduled for elective caesarean section under subarachnoid block anaesthesia.
2.Willing to provide written informed consent.
3.Age between 20 and 40 years |
|
| ExclusionCriteria |
| Details |
1. Pregnancy HDP Disorder.
2. Pregnancy complication like Placenta Praevia, Placenta Acreta.
3. Cardiac arrhythmias.
4. Pre pregnancy BMI more than 30 Kg per meter square |
|
|
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 |
• Mean Systolic Blood Pressure
• Mean Diastolic Blood Pressure
• Mean of Mean Arterial Pressure
• Mean Heart Rate
• Mean Saturation
• Proportion of cases developing Hypotension.
• Mean total dose of vasopressor required. |
Every 3 minutes for the first 15 minutes and subsequently every 5 minutes until the end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to first hypotensive episode
2 Total vasopressor requirement
3 Number of hypotensive episodes
4 Incidence of nausea vomiting
5 Highest sensory & motor block levels
6 Maternal heart rate changes Neonatal Apgar scores at 1 & 5 min Need for neonatal resuscitation Maternal satisfaction score |
Every 3 minutes for the first 15 minutes & subsequently every 5 minutes until the end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/02/2026 |
| 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="0"
Months="9"
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 aims to compare the effect of immediate vs delayed supine positioning after spinal anaesthesia on the occurrence of maternal hypotension during cesarean section.After giving spinal anaeathesia woman will be randomly assigned to either be placed supine immediatly or kept in left lateral till for 5 minutes before supine position.BP and others vital parameters will be monitered and any fall in BP will be treated as per protocol.The study will help determined whether delaying the supine position reduces the low BP and improve maternal and neonatal outcomes. |