| CTRI Number |
CTRI/2024/04/066137 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of severity of Anemia with 5 min Heart Rate Variability in pregnant females of second trimester. |
|
Scientific Title of Study
|
Association of severity of Anemia with 5 min Heart Rate Variability in pregnant females of second trimester at tertiary care hospital of West India |
| 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 Rinkal Chavda |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Resident room, Department of Physiology, Government Medical College Bhavnagar
Bhavnagar – 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408116858 |
| Fax |
|
| Email |
rinkalchavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College |
| Address |
Department of Physiology, Government Medical College, Bhavnagar, Bhavnagar - 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9898361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi vithal |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College |
| Address |
Department of Obstetrics & Gynecology, Government Medical College Bhavnagar , Bhavnagar-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
8980806068 |
| Fax |
|
| Email |
tiwariaditi085@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, behind ST bus stand , jail road ,Bhavnagar - 364001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
Government Medical College, behind ST bus stand , jail road ,Bhavnagar - 364001 |
| 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 Rinkal Chavda |
Sir Takhtasinhji General Hospital |
Room no. 1,Obstetrics-gynecology OPD, Gopnath Maternity home
Bhavnagar
GUJARAT |
9408116858
rinkalchavda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Government Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Case : Pregnant (13-28 weeks of gestation) Women with a Singleton , Live fetus with anaemia
Control : Non-Anaemic Pregnant (13-28 weeks of gestation) women with a Singleton , Live fetus.
|
|
| ExclusionCriteria |
| Details |
Any medical condition (such as hypertension , gestational diabetes mellitus, or any other chronic medical illness) complicating pregnancy
ECG showing Irregular rhythm
Participant with pacemaker
Participant with Cardio-vascular intervention.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate heart rate variability with severity of anemia in second trimester pregnant participants having anemia. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare heart rate variability among second trimester pregnant participants with anemia & normal second trimester pregnant females. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/05/2024 |
| 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="0"
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
|
q
Previous study show reduced HRV in all three trimester of pregnancy
compared to normal starting from first trimester itself.
q Anemia can also call for
sympathetic overactivity to meet circulatory demand and severity of Anemia can
have graded worsening of HRV.
q
In light of this, we intend to study HRV in second trimester pregnant
female in relation to anemia and its severity.
q
It can suggest whether cardiac Autonomic Imbalance is linked with severity of
anaemia or not. â—Study
design:
A cross-sectional study
â—Study
Population : Pregnant (13-28 weeks of gestation) Women
with a Singleton , Live fetus
with recent hemogram coming to Ob-Gy
OPD
â—Study
setting:
Department of Ob-Gy.
â—Study
Duration : 6
months (4+2)
â—Duration
of Data collection : 4 months
â—Sample
size: 80 Case and 40 Control
(Raosoft
sample size calculator)
â—Sampling
method: convenient sampling |