| CTRI Number |
CTRI/2014/12/005311 [Registered on: 17/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective analysis of clinical data |
| Study Design |
Other |
|
Public Title of Study
|
To understand the acceptance of a modern contraceptive method after undergoing a structured counselling by a trained counsellor after consultation with a gynecologist. |
|
Scientific Title of Study
|
Impact of structured counselling with trained counselors: a retrospective analysis from a multi-centric project. |
| Trial Acronym |
IMPACT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shakuntla Kumar |
| Designation |
Consultant Obstetrician and Gynecologist |
| Affiliation |
Nulife Hospital and Maternity Centre |
| Address |
Nulife Hospital and Maternity Centre
1616 Outram Lines
Guru Teg Bahadur Nagar
New Delhi
New Delhi
DELHI
110009
India |
| Phone |
01147005555 |
| Fax |
|
| Email |
drshakuntlakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shakuntla Kumar |
| Designation |
Consultant Obstetrician and Gynecologist |
| Affiliation |
Nulife Hospital and Maternity Centre |
| Address |
Nulife Hospital and Maternity Centre
1616 Outram Lines
Guru Teg Bahadur Nagar
New Delhi
New Delhi
DELHI
110009
India |
| Phone |
01147005555 |
| Fax |
|
| Email |
drshakuntlakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakuntla Kumar |
| Designation |
Consultant Obstetrician and Gynecologist |
| Affiliation |
Nulife Hospital and Maternity Centre |
| Address |
Nulife Hospital and Maternity Centre
1616 Outram Lines
Guru Teg Bahadur Nagar
New Delhi
New Delhi
DELHI
110009
India |
| Phone |
01147005555 |
| Fax |
|
| Email |
drshakuntlakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organon India Private Limited |
|
|
Primary Sponsor
|
| Name |
Organon India Private Limited |
| Address |
8th Floor Platina Building
Plot number C 59 Block G
Bandra Kurla Complex
Bandra East
Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipti Nabh |
Dr Nabhs Mother and Child Clinic |
H2, 1 Krishna Nagar. East Delhi, New Delhi
New Delhi
DELHI |
01122051960
diptinabh@gmail.com |
| Dr Praveen Garg |
Hitaishi Hospital and Heart Clinic |
154, E-15, 1st floor, Sector 8, Rohini, New Delhi
New Delhi
DELHI |
01127949211
praveengarghitaishi@gmail.com |
| Dr Shakuntla Kumar |
Nulife Hospital and Maternity Centre |
1st Floor, 1616 Outram Lines
Guru Teg Bahadur Nagar,
New Delhi
New Delhi
DELHI |
01147005555
drshakuntlakumar@gmail.com |
| Dr Rupam Arora |
Private Clinic |
78, Ground floor, Mausam Vihar. New Delhi
New Delhi
DELHI |
9810446344
rupamarora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SPECT IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women requiring contraception and agreeing to undergo counselling |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Retrospective analysis of the data on contraceptive method chosen after women in the reproductive age who desired contraception were counselled. |
|
| ExclusionCriteria |
| Details |
Women who did not desire contraception and women whose data could not be captured |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the adopted modern contraceptive method post counselling with past contraceptives ever used
To determine use rates of each contraceptives after counselling
To determine use rates of each modern contraceptives after counselling in different profile of women (post-partum, post-abortion and general)
|
Will be assessed only once post the counselling session with the counselor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine use rates of each modern contraceptives after counselling in different profile of women (post-partum, post-abortion and general) |
once only post couneseling |
|
|
Target Sample Size
|
Total Sample Size="351"
Sample Size from India="351"
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)
|
18/03/2013 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Retrospective Data to be Analyzed --- "none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a retrospective, non-interventional study. Retrospective design has been chosen since the project is already complete. Patient data collection forms which were collected during the project will be entered into the database for analysis.
Inclusion criteria for analysis:
- Women who underwent counselling during the project. Although the estimated sample size is 170, the data of 351 women would be analyzed as all of them have undergone counselling during the project
Exclusion criteria:
- Incomplete patient data collection forms
Individual patient informed consent is not available and patient identifying information was neither inquired, nor documented. However, this study will be initiated post approval from Independent ethics committee.
Outcome measures
The following outcome measures will be evaluated.
Primary end point:
- Comparison of proportion of women choosing one of the modern contraceptive after counseling with their past contraceptive history
Secondary end points:
- Proportion of women opting for any of the contraceptives after counselling
Proportion of women opting each of the modern contraceptives after counselling in different profile of women (post abortion, post-partum and general group [without post-partum and post-partum]) |