| CTRI Number |
CTRI/2026/03/105119 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess decreased BP after giving spinal anaesthesia and how a positional change can prevent it. |
|
Scientific Title of Study
|
Prevention of Post Spinal Anaesthesia Hypotension in Lower Segment Caesarean Section using Delayed Supine Positioning: A Comparative Study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Chandel |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9573105949 |
| Fax |
|
| Email |
shrutschandel.24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
bhavini.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
bhavini.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Shruti Chandel |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Shruti Chandel |
Dr. D.Y. Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9573105949
shrutschandel.24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and recognition committee under the faculty of medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed supine position |
Delaying supine position in a patient by making them sit for 2 minutes and reducing post spinal hypotension |
| Comparator Agent |
Immediate supine positioning |
Making a patient lie down in supine position immediately after giving spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients who have given informed consent, ASA 1 and 2 fit patients, Singleton full-term patients posted for elective LSCS under spinal anaesthesia, hemodynamically stable patients with all investigations within normal limits, |
|
| ExclusionCriteria |
| Details |
Less than 18 yers of age, presence of foetal abnormalities, Obese patients, patients with pregnancy induced hypertensive disorders, patients with contraindications to spinal anaesthesia, patients with any previous cardiovascular, neurological, pulmonary and psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess post spinal anaesthesia hypotension in Lower Segment Caesarean Section using delayed supine positioning. |
Patients in control group will be made lie down two minutes after the administration of spinal anaesthesia and the control group will be made to lie down immediately following spinal anaesthesia and the following parameters will be observed:
Hemodynamic changes-HR, SBP, DBP, MAP, SpO2
• Level of block-Both sensory and motor
• The requirements of total dose of vasopressor given.
• Assessment of APGAR Score of the neonates at 1 and 5 minutes after birth.
• Any untoward effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of delayed supine positioning over post spinal anaesthesia hypotension. |
Vital assessment to be done at the beginning of the surgery, followed by 2,4,6,8,10,15,20,25,30,35,40 & 45 minutes with the APGAR Score measurement of neonates at 1min & 5 mins after birth, followed by any vasopressor used & and adverse effects. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/03/2026 |
| 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="1"
Months="6"
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
|
It is a Prospective, randomized, comparative study with the aim of assessing post spinal anaesthesia hypotension in Lower Segment Caesarean Section using delayed supine positioning. The objectives are to observe incidence of hypotension, to observe hemodynamic changes, to ascertain total requirement of vasopressor in both groups, to assess the APGAR score of neonates at 1 and 5 minutes after birth in both groups and to identify any side effects in both groups, if any. |