| CTRI Number |
CTRI/2023/06/054468 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO ASSESS HEMOGLOBIN STATUS AND TO ASSESS KNOWLEDGE REGARDING ANEMIA AMONG POSTPARTUM MOTHERS IN RURAL AREA OF BELAGAVI-
A COMMUNITY BASED CROSS SECTIONAL STUDY |
|
Scientific Title of Study
|
PREVALENCE OF ANEMIA AMONG POSTPARTUM MOTHERS IN RURAL AREA OF BELAGAVI-
A COMMUNITY BASED CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MDC/JNMCIEC/191 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KARTHIK V |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI, KARNATAKA 590010 |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE, J N MEDICAL COLLEGE, BELAGAVI, KARNATAKA 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7708386994 |
| Fax |
|
| Email |
drkarthikvaradaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr UMESH S CHARANTIMATH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI, KARNATAKA 590010 |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE, J N MEDICAL COLLEGE, BELAGAVI, KARNATAKA 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9663712777 |
| Fax |
|
| Email |
drumesh.charantimath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KARTHIK V |
| Designation |
POST GRADUATE |
| Affiliation |
J N MEDICAL COLLEGE BELAGAVI, KARNATAKA 590010 |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE, J N MEDICAL COLLEGE, BELAGAVI, KARNATAKA 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7708386994 |
| Fax |
|
| Email |
drkarthikvaradaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE BELAGAVI KARNATAKA 590010 |
|
|
Primary Sponsor
|
| Name |
Dr KARTHIK V |
| Address |
ROOM NO 418 NRI PG HOSTEL
J N MEDICAL COLLEGE
BELAGAVI, KARNATAKA 590010 |
| 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 |
| Dr KARTHIK V |
J N MEDICAL COLLEGE BELAGAVI KARNATAKA 590010 |
Department Of Community Medicine,
Jawaharlal Nehru Medical College, Belagavi,
karnataka - 590010
Belgaum
KARNATAKA |
7708386994
drkarthikvaradaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Female |
| Details |
ALL POSTNATAL MOTHERS ATTENDING REGULAR VISITS IN PHC VANTAMURI, BELAGAVI DISTRICT.
|
|
| ExclusionCriteria |
| Details |
MOTHERS HAVING ANY COMPLICATION OR RECEIVED BLOOD TRANSFUSION AFTER DELIVERY. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE PREVALENCE OF ANEMIA AMONG POSTPARTUM RURAL WOMEN |
24 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE KNOWLEDGE REGARDING ANEMIA IN POSTPARTUM RURAL MOTHERS |
24 WEEKS |
| TO ASSESS THE WHO QUALITY OF LIFE QUESTIONNAIRE FOR POSTNATAL MOTHERS |
24 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
10/07/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
A COMMUNITY BASED CROSS SECTIONAL STUDY AMONG 130 POSTNATAL MOTHERS WILL BE CONDUCTED TO ASSESS THE PREVALENCE OF ANEMIA, KNOWLEDGE REGARDING ANEMIA AND WHO QUALITY OF LIFE QUESTIONNAIRE IN RURAL AREA OF BELAGAVI. DATA WILL BE COLLECTED USING PREDESIGNED PRESTRUCUTRED QUESTIONNAIRE REGARDING SOCIODEMOGRAPHIC DETALIS, KNOWLEDGE REGARDING ANEMIA AND WHO QUALITY OF LIFE QUESTIONNAIRE FOR POSTNATAL MOTHERS IN RURAL AREA OF BELAGAVI. ESTIMATION OF HB WILL BE DONE IN KLE DR PRABHAKAR KORE HOSPITAL AND RESEARCH MEDICAL CENTER BELAGAVI WITH THE CONSENT OF THE PARTICIPANTS. |