| CTRI Number |
CTRI/2026/02/103042 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Point-of-care Haemoglobin measurement in patients with High-risk Pregnancies undergoing Caesarean section |
|
Scientific Title of Study
|
Evaluation of Point of care Haemoglobin measurement in patients with High risk Pregnancies undergoing Caesarean section An observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani s |
| Designation |
Junior resident |
| Affiliation |
Manipal Academy of Higher Education. |
| Address |
Department of anaesthesia, kasturba hospital, manipal, madhav nagar, udupi district, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349352727 |
| Fax |
|
| Email |
Shivani9739@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malavika kulkarni |
| Designation |
head of the department |
| Affiliation |
Manipal Academy of Higher Education. |
| Address |
Department of anaesthesia, kasturba hospital, manipal, madhav nagar, udupi district, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shivani s |
| Designation |
Junior resident |
| Affiliation |
Manipal Academy of Higher Education. |
| Address |
Department of anaesthesia, kasturba hospital, manipal, madhav nagar, udupi district, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349352727 |
| Fax |
|
| Email |
Shivani9739@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba hospital, manipal, madhav nagar, udupi district,karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani S |
| Address |
Department of anaesthesia, kasturba hospital, manipal, madhav nagar, udupi district, 576104 |
| 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 Shivani S |
kasturba hospital,manipal |
department of anaesthesiology,kmc manipal,576104
Udupi
KARNATAKA |
7349352727
shivani9739@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Anaemia
Preexisting Medical Conditions such as Diabetes Mellitus
Hypertension
Cardiac disease
Autoimmune diseases
Complications during Pregnancy such as Gestational Diabetes
Preeclampsia
Placental disorders
Bleeding and Coagulation disorders
Multiple Pregnancies
Previous LSCS |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demonstration of clinical utility and reliability of HemoCue in the high-risk obstetric population.
Potential integration into perioperative protocols to improve maternal safety and expedite management
of hemorrhage |
Pre operative and post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
15/02/2026 |
| 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="2"
Months="0"
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
|
The purpose of this study is to evaluate the accuracy and reliability of point-of-care (HemoCue) haemoglobin measurements compared to
standard laboratory values in high-risk pregnant patients undergoing caesarean
section.Total of 91 patients will be recruited who come under the category of high risk pregnant patients who are undergoing caesarean section. Pre operative and post operative hemocue hb will be compared with pre operative and post operative lab Hb and see if it is accurate and also reliable to make blood transfusion related decisions
perioperatively in high risk patients undergoing caesarean section.
|