| CTRI Number |
CTRI/2017/02/007951 [Registered on: 22/02/2017] Trial Registered Prospectively |
| Last Modified On: |
08/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative descriptive analysis |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Attitude of women on gender preference and female feticide |
|
Scientific Title of Study
|
A study of the Attitude on Gender Preference and Female Feticide among Women in selected settings at Mangaluru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mercy Zonunsiami |
| Designation |
PG Student |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Phunchawngi Veng
New Bazar
Churachandpur
Manipur
Father Muller College of Nursing
Kankanady
Mangaluru
Churachandpur
MANIPUR
795128
India |
| Phone |
9108771039 |
| Fax |
|
| Email |
mercy.zonunsiami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Darryl Monica Serafine Aranha |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College of Nursing
Kankanady
Mangaluru
Father Muller College of Nursing
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9481346802 |
| Fax |
|
| Email |
aranhadarryl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Shwetha Rashmi M S |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College of Nursing
Kankanady
Mangaluru
Father Muller College of Nursing
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9740510036 |
| Fax |
|
| Email |
shwetharashmi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
FMCI
Kankanady |
|
|
Primary Sponsor
|
| Name |
Mercy Zonunsiami |
| Address |
Phunchawngi Veng
New Bazar
Churachandpur Manipur |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Savitha Pramilda Cutinho |
Father Muller Medical College Hospital |
Room no2,1st Floor
MRD Building
Kankanady
Mangalore
575002
Antenatal OPD 19
Father Muller Medical College Hospital
Kankanady
Mangaluru
575002
Dakshina Kannada
KARNATAKA |
9740687444
savithacutinho@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Married women Group A |
In this study, it refers to women who are married and visiting the antenatal OPD for the first time in Mangaluru. Marital status will be assessed by demographic baseline proforma |
| Comparator Agent |
Unmarried women Group B |
In this study, it refers to women who are unmarried in the age group of 21 to 30 years, either studying or working at different Institutions in Mangaluru. Marital status will be assessed by demographic baseline proforma |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried women who are studying or working in Institutions.
Married nulliparous women
Married women who can read and write [Kannada, English, Hindi]
|
|
| ExclusionCriteria |
| Details |
Married and unmarried women who are mentally challenged |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Women will recognise self acknowledgement towards gender preference |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Women will know harmful effects of female feticide |
1 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
27/02/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To identify the attitude of women on gender preference and female feticide
To compare the attitude of women on gender preference and female feticide
To find the association of attitude of women with selected demographic variables
|