| CTRI Number |
CTRI/2010/091/000175 [Registered on: 15/04/2010] |
| Last Modified On: |
13/08/2011 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Monitoring of High Risk Pregnancy patients based on Ultrasound Doppler |
|
Scientific Title of Study
|
Pregnancy Monitoring Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PMS333 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Celine Firtion |
| Designation |
|
| Affiliation |
|
| Address |
Philips Innovation Campus
Manyata Tech Park,Nagavara
Bangalore
KARNATAKA
560045
India |
| Phone |
+91 80 41890000 |
| Fax |
+ 91 80 4189 2265 |
| Email |
celine.firtion@philips.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Celine Firtion |
| Designation |
|
| Affiliation |
|
| Address |
Philips Innovation Campus
Manyata Tech Park,Nagavara
Bangalore
KARNATAKA
560045
India |
| Phone |
+91 80 41890000 |
| Fax |
+ 91 80 4189 2265 |
| Email |
celine.firtion@philips.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Celine Firtion |
| Designation |
|
| Affiliation |
|
| Address |
Philips Innovation Campus
Manyata Tech Park,Nagavara
Bangalore
KARNATAKA
560045
India |
| Phone |
+91 80 41890000 |
| Fax |
+ 91 80 4189 2265 |
| Email |
celine.firtion@philips.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Philips |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Prathima Radhakrishnan |
Bangalore Fetal Medicine, C.J. D' Souza Road |
C.J. D' Souza Road,-560025
Bangalore
KARNATAKA |
|
| Dr. Beula Emmanuel |
Bharat Scans Pvt Ltd |
197, Peters Road,Royapettah-600014
Chennai
TAMIL NADU |
+91 98417 49507
+91 44 28518462
dremmanuel@bharatscans.com |
| Dr. Sandeep Sharma |
C- l5 MRI lmaging & Diagnostic Research Centre |
C-15, Green Park Extension,-110016
New Delhi
DELHI |
|
| Dr. Suneet Jolly |
Dr. Jolly?s Diagnostic Centre |
E-343C , GK-Part I (Near Guruduara),-110048
New Delhi
DELHI |
|
| Dr. Manoj K.S |
Health and Research Centre |
2nd Floor, Devi Scan Buildings,Kumarapuram Medical College (Post)-695011
|
+91 98462 12397
manojks16@yahoo.com |
| Prof. S. Suresh |
Mediscan |
197,Dr.Natesan Road,,Mylapore-600004
Chennai
TAMIL NADU |
|
| Dr. Srinivasan. M.N |
Pristine Hospital |
#877, Modi Hospital Road,West of Chord Road,2nd stage Extension-560086
Bangalore
KARNATAKA |
+91 98451 66705
drsrinivasanmn@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Bangalore Fetal Medicine Centre: Independent Human Ethics Committee, Health And Research Centre,Tiruvandrum |
Approved |
| Chennai Site Ethics Committee: Independent Human Ethics Committee, Health and Research Centre,Tiruvandrum |
Approved |
| Ethics Committee Of Pristine Hospital And Research Centre Private Limited,Pristine Hospital,Bangalore |
Approved |
| Institutional Review Board, Fetal Care Research Foundation, Mediscan, 197, Dr. Natesan Road, Mylapore, Chennai-600004, Tamilnadu |
Approved |
| Trivandrum Site Ethics Committee: Independent Human Ethics Committee, Health and Research Centre,Tiruvandrum |
Approved |
| Trivandrum Site Ethics Committee: Independent Human Ethics Committee, Health And Research Centre,Tiruvandrum |
Approved |
| Trivandrum Site Ethics Committee: Independent Human Ethics Committee, Health And Research Centre,Tiruvandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Controlled Intervention in this study |
NIL |
| Intervention |
No intervention in this study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Should be older than or atleast 18 years old
Singleton or Multiple Pregnancy
Pregnancy should be normal, or with one or more of the following past history or complications (like maternal diabetes,renal disease,heart disease,Thyroid and other hormonal disorders, coagulation disorder,hypertension,IUGR,gestational diabetes) |
|
| ExclusionCriteria |
| Details |
Pregnancy less than 12 weeks of gestation
Presence of a complication of pregnancy other than the ones cited in the inclusion criteria
Presence of fetal Malformation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To collect clinical data for training and testing algorithms |
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pregnancy Monitoring Study is intended to collect clinical data for training and testing algorithms. We will be using only currently available non-invasive devices for this study (Ultrasound-Doppler) at 5 centres in India. |