| CTRI Number |
CTRI/2020/09/027754 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
07/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the awareness of pregnant women about the diseases which can be passed through families or the diseases which they can pass to there babies and the tests which can detect the disease before the baby is born. |
|
Scientific Title of Study
|
Knowledge and Attitude of pregnant women towards genetic disorders and prenatal testing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Darshan |
| Designation |
Postgraduate in obstetrics and gynecology |
| Affiliation |
Maulana Azad Medical College and associated Loknayak hospital New delhi |
| Address |
Obstetrics and gynaecology department gate no 2 LOKNAYAK HOSPITAL associated with Maulana Azad medical college ,bahadur shah zafar marg ,New Delhi 110002
OBSTERICS AND GYNECOLOGY department office ground floor maternity building gate no 2 Loknayak hospital associated with Maulana Azad Medical College New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
07204647668 |
| Fax |
|
| Email |
drsoumyadarshan2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Gupta |
| Designation |
HOU and Consultant unit 6 Obstetrics and gynaecology department Loknayak hospital New Delhi |
| Affiliation |
HOU and consultant Obstetrics and Gynaecology department Loknayak hospital New Delhi |
| Address |
LOK NAYAK HOSPITAL obstetric and gynaecology department gate no 2
Bahadur shaahzafar marg
New delhi 110002
Loknayak hospital gate no 2 obstetrics and gynecology department office ground floor maternity building New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
08368199481 |
| Fax |
|
| Email |
drsangeetamamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Darshan |
| Designation |
Postgraduate in obstetrics and gynecology |
| Affiliation |
Post graduate in obstetrics and Gynecology dept Maulana Azad medical college |
| Address |
LOKNAYAK HOSPITAL OBSTETRICS AND GYNECOLOGY department associated with Maulana azad medical college bahdur shah zafar marg New Delhi 110002
Loknayak hospital gate no 2 obstetrics and Gynecology Department New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
07204647668 |
| Fax |
|
| Email |
drsoumyadarshan2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Loknayak hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Loknayak hospital |
| Address |
Maulana Azad Medical College Bahadur shahzafar marg New delhi 110002 |
| 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 |
| Soumya Darshan |
Loknayak hospital associated with Maulana Azad Medical College New Delhi |
Loknayak Hospital, Obstetrics and gynecology department,New Delhi ,bahadur shah zafar marg 110002
Central
DELHI |
07204647668
drsoumyadarshan2020@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 |
| Healthy Human Volunteers |
Pregnant women in any trimester |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women of any trimester visiting antenatal clinic Or admitted in the wards of Department of Obstetrics and Gynecology in Maulana Azad Medical College & associated Loknayak hospital,New Delhi |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the knowledge and attitude of pregnant women with or without affected child or family history towards genetic disorders, its risk factors and their prenatal testing.
To assess the willingness of pregnant women to undergo prenatal tests.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the willingness of pregnant women to undergo prenatal tests. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
17/09/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary outcome of the study is to assess the knowledge and attitude of pregnant women with and without affected child or family history towards genetic disorders, it’s risk factors and their prenatal testing and to assess the willingness to undergo prenatal tests. Pregnant women visiting ANC clinic or admitted in maternity ward of department of obstetrics and gynaecology will be interviewed. Knowledge and attitude of pregnant women towards genetic disorder and prenatal testing will be assessed with the questionnaire with respondants indicating "yes"," no" Or "don’t know" In response to the question. Knowledge will be categorised as "good", "poor" Based on wheather they scored above or below 70% of correct response to the items of knowledge asked. The questionnaire are self designed and validated questionnaire and it will be interviewer administered. |