| CTRI Number |
CTRI/2025/04/085744 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Effect of tying crepe bandage on both legs before baby delivery operation to avoid fall in blood pressure after anesthesia by monitoring |
|
Scientific Title of Study
|
Effects of leg wrapping on the correlation of perfusion index as a marker of hypotension in caesarean section under spinal anaesthesia - A Prospective clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Tholath Mehal Rajan Matthews |
| Designation |
Postgraduate MD Anesthesia |
| Affiliation |
Mahatma Gandhi Medical College Research Institute - Puducherry |
| Address |
Department of Anesthesiology Mahatma Gandhi Medical College & Research Institute Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
09840783897 |
| Fax |
|
| Email |
dr.mehalrajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yasha V Kameshwar |
| Designation |
Associate Professor, Department of Anesthesiology and Pain Medicine |
| Affiliation |
Mahatma Gandhi Medical College Research Institute - Puducherry |
| Address |
Department of Anesthesiology and Pain Medicine, Mahatma Gandhi Medical College & Research Institute Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
982576763 |
| Fax |
|
| Email |
yasha.vdk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yasha V Kameshwar |
| Designation |
Associate Professor, Department of Anaesthesiology and Pain Medicine |
| Affiliation |
Mahatma Gandhi Medical College Research Institute - Puducherry |
| Address |
Department of Anesthesiology and Pain Medicine, Mahatma Gandhi Medical College & Research Institute Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
982576763 |
| Fax |
|
| Email |
yasha.vdk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine, Mahatma Gandhi Medical College & Research Institute - Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tholath Mehal Rajan Mathews |
Mahatma Gandhi Medical College & Research Institute Pondicherry 607402 |
Department of Anesthesiology and Pain Medicine, C 201
Pondicherry
PONDICHERRY |
09840783897
dr.mehalrajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Human Ethics Committee (IHEC) of Mahatma Gandhi Medical College & Research Institute Puducherry MGMCRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA II ,Age 20-35 years, Pregnant women posted for elective caesarean section , Belonging to status with a weight between 50 and 80 kg height between 140 and 165 cm will be included. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Arterial Pressure |
Baseline, 2 min, 4 min, 6 min, 8 min, 10 min, 12 min, 14 min, 16 min, 18 min, 20 min after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure MAP in parturients undergoing lscs under spinal anaesthesia until baby
delivery. |
Baseline, 2 min, 4 min, 6 min, 8 min, 10 min, 12 min, 14 min, 16 min, 18 min, 20 min after spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/05/2025 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to email ID to
dr.mehalrajan@gmail.com. After relevant assessment of credibility of the requester and the purpose, it will be provided.
- For how long will this data be available start date provided 22-10-2025 and end date provided 28-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Caesarean section is commonly performed under spinal anaesthesia (SAB). Due to various untoward maternal and foetal outcomes associated with hypotension which frequently occurs after SAB, numerous indicators have been explored for ensuring patient safety.1,2,3 Perfusion index (PI) is a continuous, non-invasive photoplethysmographic pulse wave that can be used to measure changes in peripheral vascular tone-related peripheral perfusion dynamics. It has been proven to be a reliable indicator of maternal hypotension after SAB.4 Leg wrapping is a simple, inexpensive, non-pharmacological method that can be performed every day to prevent hypotension.5 We proposed the hypothesis that the efficacy of leg wrapping with crepe bandage before spinal anaesthesia in pregnant female undergoing caesarean section can prevent hypotension. But there is paucity of literature on studies corelating its effect on preventing hypotension as indicated through perfusion index. Hence, we want to conduct this study to elicit the effects of leg wrapping on the correlation of perfusion index as a marker of hypotension in caesarean section under spinal anaesthesia. |