| CTRI Number |
CTRI/2024/08/072308 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood utilization in obstetric patients in tertiary care hospital Bhavnagar |
|
Scientific Title of Study
|
Blood utilization in obstetric patients in tertiary care hospital Bhavnagar: A cross sectional 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 |
Dr Preksha V Prajapati |
| Designation |
1st year Resident, Department of Pathology |
| Affiliation |
Government Medical college Bhavnagar |
| Address |
Department of Pathology, Government Medical College, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9712975628 |
| Fax |
|
| Email |
prexap990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragnesh H Shah |
| Designation |
Professor, Department of Pathology |
| Affiliation |
Government Medical college, Bhavnagar |
| Address |
Department of Pathology, Government Medical college, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428106604 |
| Fax |
|
| Email |
drphshah73@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragnesh H Shah |
| Designation |
Professor, Department of Pathology |
| Affiliation |
GMC BHAVNAGAR |
| Address |
Department of Pathology, Government Medical college, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428106604 |
| Fax |
|
| Email |
drphshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college bhavnagar 364001 GUJARAT INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Preksha V Prajapati |
| Address |
Department of Pathology, Government Medical College, Bhavnagar |
| 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 Pragnesh H SHAH |
Sir Takhtasinhji general hospital |
Room number 9,Blood bank, department of pathology,Sir Takhtasinhji general hospital and government medical college bhavnagar 364001 GUJARAT BHAVNAGAR
Bhavnagar
GUJARAT |
9428106604
drphshah73@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Obstetric patients admitted in sir Takhtasinhji General Hospital Bhavnagar whose blood request is received in blood bank sir Takhtasinhji General Hospital |
|
| ExclusionCriteria |
| Details |
Obstetric patients admitted in sir Takhtasinhji General Hospital Bhavnagar whose blood request form is not filled properly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood and blood component utilization in obstetric patients |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
22/08/2024 |
| 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="0"
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
|
Maternal
mortality is recognized as an important global health problem with Obstetric
haemorrhage being the leading cause in developing countries
Blood
transfusion is identified as one of the essential components of comprehensive
emergency Obstetric care which has major role in reducing the Maternal
mortality
The causes
of pregnancy associated complications requiring transfusion are Postpartum
haemorrhage, Anaemia, Pre eclampsia, First trimester bleeding,
Abruptio Placenta etc |