| CTRI Number |
CTRI/2018/07/014760 [Registered on: 06/07/2018] Trial Registered Prospectively |
| Last Modified On: |
04/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
low haemoglobin in pregnancy and cardiovascular cahnges |
|
Scientific Title of Study
|
A cross-sectional study of effect of anemia on pulse wave analysis parameters in normal pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant professor in Physiology |
| Affiliation |
Govt Medical College, Bhavnagar |
| Address |
Department of Physiology,
fourth floor,
Govt Medical College, Bhavnagar,
Behind S T bus stand,
Jail Road
Bhavnagar
GUJARAT
364001
India |
| Phone |
9898361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant professor in Physiology |
| Affiliation |
Govt Medical College, Bhavnagar |
| Address |
Department of Physiology,
fourth floor,
Govt Medical College, Bhavnagar,
Behind S T bus stand,
Jail Road
GUJARAT
364001
India |
| Phone |
9898361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant professor in Physiology |
| Affiliation |
Govt Medical College, Bhavnagar |
| Address |
Department of Physiology,
fourth floor,
Govt Medical College, Bhavnagar,
Behind S T bus stand,
Jail Road
GUJARAT
364001
India |
| Phone |
9898361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt Medical College Bhavnagar |
| Address |
Govt Medical College Bhavnagar
Jail Road
Bhavnagar |
| 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 Jayesh Solanki |
Sir T Hospital Bhavnagar |
Gynecology department OPD,
New OPD complex,
Sir T Hospital,
Jail Road
Bhavnagar
Bhavnagar
GUJARAT |
9898361004
drjaymin_83@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Government Medical College Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
females with singleton uncomplicated pregnancy
with anemia status known, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anemia |
will be graded as per hemoglobin level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
-Singleton pregnant female- First or second Trimester of pregnancy- Ready for written informed consent- Age between 18 to 40 years of any parity.- Current anemia status known- No history of cardiovascular disease - Not taking any autonomic drugs- Not having other disease - Taking regular ante natal check up |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:-Not ready for written informed consent-Age more 40 years.-Third trimester of pregnancy- history of cardiovascular disease- taking any autonomic drugs-Having complication of pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular parameters in reference to anemia |
Outcome measured by single cross sectional measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
23/07/2018 |
| 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
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We will recruit 150 females of first or second trimester with normal singleton pregnancy
They will be graded for anemia Pulse wave analysis will be done by MOBILOGRAPH to derive brachial haemodynamics, central haemodynamics and arterial stiffness parameters
Parameters will be compared between anemic and non-anemic feamles |