| CTRI Number |
CTRI/2024/05/068022 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Contraception among females with heart diseases |
|
Scientific Title of Study
|
A Study to Assess the Awareness and Willingness to adopt Contraception among females with Preexisting Cardiac Conditions at AIIMS New Delhi with a view to provide Video-Based Teaching |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini |
| Designation |
M.Sc. Nursing (Cardiological/CTVS) Student |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 5
Porta Cabin
College of Nursing
Near Old OT Block
AIIMS, New Delhi
Ansari Nagar
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
8580824883 |
| Fax |
|
| Email |
tulushalini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Das |
| Designation |
Associate Professor, College of Nursing |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 1
Second Floor
Porta Cabin
College of Nursing
Near Old OT Block
AIIMS, New Delhi
Ansari Nagar
New Delhi
Delhi
110029
India
South
DELHI
110029
India |
| Phone |
9971755375 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 1
Second Floor
Porta Cabin
College of Nursing
Near Old OT Block
AIIMS, New Delhi
Ansari Nagar
New Delhi
Delhi
110029
India
South
DELHI
110029
India |
| Phone |
9971755375 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing
Near Old OT Block
AIIMS, New Delhi
Ansari Nagar
New Delhi
India
Pin Code-110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Das |
AIIMS, New Delhi |
Cardiology OPD
Ground floor
Cardiothoracic center
AIIMS New Delhi
Ansari Nagar
New Delhi
Delhi
India
110029
South
DELHI |
9871755375
smitadas307@gmail.com |
| Dr Smita Das |
AIIMS, New Delhi |
OBG OPD
Ground Floor
Maternal and Child Block
AIIMS New Delhi
Ansari Nagar
New Delhi
Delhi
India
110029
South
DELHI |
9871755375
smitadas307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I019||Acute rheumatic heart disease, unspecified, (2) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, (3) ICD-10 Condition: I429||Cardiomyopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females having pre-existing heart diseases within the age of 21-45 years, visiting cardiology and OBG OPD at AIIMS New Delhi |
|
| ExclusionCriteria |
| Details |
females with permanent sterilization and not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge and willingness regarding Contraception
|
Knowledge and willingness will be assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Study Title: A Study to Assess the Awareness and Willingness to adopt Contraception among Females with Preexisting Cardiac Conditions at AIIMS New Delhi with a view to provide Video-Based Teaching Need of the study: CVD is the leading cause of indirect maternal mortality. There is a considerable obstetric and perinatal outcomes risk in women with heart disease. So, it is important to assess the knowledge and willingness to adopt contraception in preexisting cardiac conditions and to provide them knowledge regarding CVD and pregnancy to allow time for preconception planning and minimisation of pregnancy risks Aim: To assess the awareness and willingness to adopt contraception among females with pre-existing cardiac conditions with a view to provide video-based teaching. Method: Descriptive study Sample size: 120 |