| CTRI Number |
CTRI/2024/11/077251 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum placental growth factor (PIGF) performance prediction in early pregnancy for pregnancy outcomes |
|
Scientific Title of Study
|
Prediction performance of serum placental growth factor (PIGF) in early pregnancy for pregnancy outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Dhaka |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9461365300 |
| Fax |
|
| Email |
swapnildhaka311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9611786463 |
| Fax |
|
| Email |
shripad.hebbar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shripad Hebbar |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9461365300 |
| Fax |
|
| Email |
shripad.hebbar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college, Manipal, Udupi, karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Swapnil Dhaka |
| Address |
Department of Obstetrics and Gynaecology,
Kasturba hospital, Manipal, Udupi, Karnataka |
| 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 |
| Swapnil Dhaka |
Kasturba Medical College, Manipal |
Department of Obstetrics and Gynaecology,
Kasturba hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9461365300
swapnildhaka311@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: 1||Obstetrics, |
|
|
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 |
BOOKED ANTENATAL FEMALES DELIVERING IN OUR INSTITUTION |
|
| ExclusionCriteria |
| Details |
ANTENATAL CASES WITH COMORBIDITIES AND HAVE NOT BEEN ON REGULAR ANC VISITS WITH US |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between PIGF levels and various obstertrics outcomes |
To correlate antenatal history and delivery outcome. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study correlation between first trimester maternal characteristics PIGF, sonological features (CRL, doppler indices) and selected pregnancy complications.
|
OVER 2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="496"
Sample Size from India="496"
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)
|
11/12/2024 |
| 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="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
|
After obtaining the IEC approval and CTRI
approval, proposed study will be initiated by seeking informed consent from the study participants.
Estimation of PIGF is done as a part of PE screening which is a standard protocol in our hospital. For
all the women enrolled, first trimester NT scan report, Dual markers reports, maternal history,
symptomatology, pregnancy-related information such as gestational age will be recorded. Only the
biochemical values will be referred to and patient will not undergo PLGF testing only for the sake of
the study. Patient will not be asked to bear any additional cost for the purpose of this study. All the
study information will be noted on a predesigned proforma. The patient enrolling the hospital from
2024-2026.To study correlation between first trimester maternal characteristics PIGF, sonological features (CRL, doppler
indices) and selected pregnancy complications. |