| CTRI Number |
CTRI/2025/03/082165 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see how well an awareness program helps people in rural areas understand genetic screening. |
|
Scientific Title of Study
|
To assess the effectiveness of awareness programme on knowledge and attitude regarding genetic screening and its importance among the eligible coubles living in rural area. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maheshwari prakashrao Bombale |
| Designation |
post graduation students |
| Affiliation |
Datta Meghe Higher Education And Research |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Ground Floor , Department of Obstretrics and Gynacology of Nursing
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020564553 |
| Fax |
|
| Email |
maheshwaribombale1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Taksande |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Higher Education And Research |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Ground Floor , Department of Obstretrics and Gynacology of Nursing
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970423710 |
| Fax |
|
| Email |
vtaksande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Taksande |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Higher Education And Research |
| Address |
Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Ground Floor , Department of Obstretrics and Gynacology of Nursing
MAHARASHTRA
442001
India |
| Phone |
9970423710 |
| Fax |
|
| Email |
vtaksande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha 442001 |
| Type of Sponsor |
Private 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 Maheshwari P Bombale |
Acharya Vinoba Bhave Rural Hospital |
Dept.of Obstretics and Gynaecology, Ward No.11, First floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
7020564553
maheshwaribombale1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awareness program |
Awareness program will be delivered on knowledge and attitude regarding genetic screening and its importance among the eligible couples living in rural area of Wardha district.
first day pre-test,on same day intervention given and after seven day post-test will be taken. |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who are present at time of data collection.
2. Those who are willing to participate in the study.
3. Those who Illiterate.
|
|
| ExclusionCriteria |
| Details |
1. Those who are under gone awareness programme since 6 months on knowledge and attitude regarding genetic screening and its importance .
2.Those who are related to the health profession
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in knowledge and Attitude regarding genetic screening and its importance among eligible couple.
first day intervention given and after seven days post-test will be taken and outcome assessed. |
Change in knowledge and Attitude regarding genetic screening and its importance among eligible couple |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Prenatal testing is the best strategy for reducing the burden of genetic
disorders and congenital disabilities that cause significant postnatal
functional impairment. Universal prenatal screening is advisable for common
genetic disorders and congenital anomalies such as Down syndrome,
beta thalassaemia and neural tube defects. Several prenatal-screening tests are
now available for Down syndrome, but knowledge about the appropriate timing of
the test and the need for pre- and post-test counselling may not be updated among
the primary care physicians. this will be a community intervention in which eligible couples will be provided awareness session regarding genetic screening. |