| CTRI Number |
CTRI/2019/08/020740 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life in pregnant women with anemia |
|
Scientific Title of Study
|
A pilot study to evaluate Health related Quality of Life (QOL) in pregnant women with iron deficiency anaemia (IDA) in tertiary hospital in North India. |
| Trial Acronym |
HRQoL , IDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekha Saha |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department Of Pharmacology
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503752 |
| Fax |
|
| Email |
lekhasaha@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lekha Saha |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department Of Pharmacology
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503752 |
| Fax |
|
| Email |
lekhasaha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARDEEP KAUR |
| Designation |
student |
| Affiliation |
PGIMER |
| Address |
Department of Pharmacology
PGIMER
102, BLOCK A, Nivedita hostel
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146711455 |
| Fax |
|
| Email |
aspireachieve.shine@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored as its only an observational study |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Medical Education And ResearchPGIMER |
| Address |
Department of Pharmacology
PGIMER,sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| HARDEEP KAUR |
PGIMER |
Department of Obstetrics and Gynaecology, PGIMER
Chandigarh
CHANDIGARH |
8146711455
aspireachieve.shine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
pregnant females with iron-deficiency anemia without any other comorbidity (medical-surgical complication) |
|
| ExclusionCriteria |
| Details |
• Not willing to provide an informed consent
• With any comorbid medical/ surgical disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the HRQoL in pregnant women with iron-deficiency anaemia and factors associated with the overall QoL. |
single time point. the participants will be asked to fill the questionnaire on the day of their scheduled visit once only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the other cofactors affecting the quality of life |
single timepoint via questionnaire |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is to evaluate the quality of life in pregnant women with anemia and other factors that affect the quality of life in pregnant women with anemia |