| CTRI Number |
CTRI/2024/05/067090 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early diagnosis of low blood pressure in pregnant lady with the help of monitor. |
|
Scientific Title of Study
|
Perfusion index Tool for predicting hypotension in pre eclampsia patients undergoing lower segment caesarean section following a subarachnoid block |
| 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 Manisha Sapate |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Yashwantrao Chavan Medical Hospital,Pimpri Pune |
| Address |
Dhanwantari Main OT, !st floor, Department of Anaesthesiology, Post graduate Institute of Yashwantrao Chavan Memorial Hospital, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7722060915 |
| Fax |
|
| Email |
manisha.sapate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Sapate |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Yashwantrao Chavan Medical Hospital,Pimpri Pune |
| Address |
Dhanwantari Main OT, !st floor, Department of Anaesthesiology, Post graduate Institute of Yashwantrao Chavan Memorial Hospital, Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
7722060915 |
| Fax |
|
| Email |
manisha.sapate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Bandgar |
| Designation |
PG Resident |
| Affiliation |
Post graduate Institute, Yashwantrao Chavan Memorial Hospital |
| Address |
Dhanwantari Main OT, !st floor, Department of Anaesthesiology, Post graduate Institute of Yashwantrao Chavan Memorial Hospital, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7798576165 |
| Fax |
|
| Email |
aditi369bandgar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Yashwantrao Chavan Memorial Hospital, Sant Tukaram Nagar, Pimpri , Pune |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Yashwantrao Chavan Memorial Hospital |
| Address |
Post Graduate Institute of Yashwantrao Chavan Memorial Hospital, sant Tukaram nagar, Pimpri, Pune |
| 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 Aditi Bandgar |
Post Graduate Institute of Yashwantrao Chavan Memorial Hospital |
Aaesthesia Department, First floor, Dhanwantari OT,YCM Hospital, Pimpri Pune
Pune
MAHARASHTRA |
07798576165
aditi369bandgar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PCMCs PGI YCMH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Pre eclampsia parturient with BP more 140/90 mmhg with geastational between 36-40 weeks |
|
| ExclusionCriteria |
| Details |
Parturients with BP exceeding 170/110 mmhg or contraindication to spinal anesthesia or inadequate sensory block achieved . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to use perfusion index as predictor of hypotension following sub arachnoid block in pre eclampsia parturient undergoing caesarian section. |
baseline till end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| for intraoperative monitoring of heart rate, SPO2 |
Every 2 minutes for first 10 min, and every 5 min till end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| 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 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 observational study will be conducted after ethical and CTRI approval. The study will done on pre eclampsia parturient undergoing lower segment caesarian section under sub arachnoid block to determine weather perfusion index can be used as a non invasive monitoring tool to predict hypotension intraoperatively for good outcome of mother and baby. |