| CTRI Number |
CTRI/2014/07/004750 [Registered on: 22/07/2014] Trial Registered Prospectively |
| Last Modified On: |
15/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPLICATIONS OF ABORTION PILLS MISUSE.
|
|
Scientific Title of Study
|
EVALUATION OF AWARENESS OF ABORTION PILLS AND COMPLICATIONS OF ITS MISUSE.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita Agarwal |
| Designation |
Senior Resident |
| Affiliation |
Deptt. obs. & gynae Safdarjung Hospital, CGHS |
| Address |
Deptt. Obs. & Gynae, Safdarjung Hospital New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9990167888 |
| Fax |
|
| Email |
drku93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Malik |
| Designation |
Consultant |
| Affiliation |
Deptt. obs. & gynae Safdarjung Hospital, CGHS |
| Address |
Deptt. Obs. & Gynae Safdarjung Hospital New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818914579 |
| Fax |
|
| Email |
svmalik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KAVITA AGARWAL |
| Designation |
Senior Resident |
| Affiliation |
Deptt. obs. & gynae Safdarjung Hospital, CGHS |
| Address |
Deptt. Obs. & Gynae Safdarjung Hospital New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9990167888 |
| Fax |
|
| Email |
drku93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAFDARJUNG HOSPITAL |
| Address |
SAFDARJUNG HOSPITAL, NEW DELHI -110029 |
| 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 |
| Dr KAVITA AGARWAL |
Safdarjung Hospital |
Deptt Obs. & Gynae
New Delhi
DELHI |
9990167888
drku93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ABORTION , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women willing to participate in the study.
2. Women with history of abortion pill intake.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Source of knowledge about abortion pill,
• Patients awareness about the drug, its side effects and complications, need for medical supervision
• Patients considering it as emergency contraceptive measure.
|
august 2014 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• MTP pill taken by patients not eligible for medical abortion,
• Complications arising out of abortion pill misuse like grade of anaemia, patients with incomplete abortions, inevitable abortion, missed abortion.
|
august 2014 |
|
|
Target Sample Size
|
Total Sample Size="1300"
Sample Size from India="1300"
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)
|
31/07/2014 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
would be a cross-sectional study to be conducted in Department of Obstetrics
and Gynaecology at Safdarjung Hospital, Delhi, after getting clearance from the
ethical committee of the institute. A sample of 1300 women is required to be recruited
in the study. Women
willing to participate in the study and with history of abortion pill intake will be included in the study. They will be interviewed by the casualty doctor
and their reply will be recorded in a pre structured proforma as per annexure III.
The proforma will
include questions to
decide the eligibility of women to take the abortion pill. The proforma will also include awareness if any, about the drug,
its side effects and their management and source of information. Patient condition at the time of admission and treatment given during hospital stay will also be included in the proforma. Data
will be analysed with simple parametric tests and the value of P<0.05 will
be considered significant.
|