| CTRI Number |
CTRI/2024/10/075307 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Study of Practices of Medical Termination of Pregnancy (MTP) in the pregnant women after recent changes in the MTP Law |
|
Scientific Title of Study
|
MTP Practices after the amendment of MTP law |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Gupta |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics & Gynaecology, Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8054463433 |
| Fax |
|
| Email |
riyagupta620@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa PS |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics & Gynaecology, Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008415729 |
| Fax |
|
| Email |
roopa.ps@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa PS |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics & Gynaecology, Kasturba Medical College, Manipal
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008415729 |
| Fax |
|
| Email |
roopa.ps@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynecology
Kasturba Hospital, MAHE campus, Manipal, Karnataka, India,
576104 |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynaecology |
| Address |
Kasturba Medical College, Manipal, MAHE |
| Type of Sponsor |
Private 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 |
| Riya Gupta |
Kasturba Hospital |
Department of Obstetrics and Gynecology, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8054463433
riyagupta620@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Women undergoing MTP from 0-24 weeks of period of gestation at Kasturba Hospital, Manipal
2. Women undergoing MTP after 24 weeks of period of gestation at Kasturba hospital, Manipal after Medical board approval |
|
| ExclusionCriteria |
| Details |
1. Those with complete spontaneous abortions
2. Those with voluntary selective reduction of a pregnancy in case of multiple gestation pregnancy.
3. Those women who do not have their obstetric history available and those who are unwilling to reveal their obstetric data are excluded from the study.
4. Those unwilling to consent to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To collect comprehensive data on the demographic profile of the patients undergoing MTP involving age, period of gestation, indication of MTP, method of MTP used and whether there are any post procedure complications. |
cross sectional study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="379"
Sample Size from India="379"
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)
|
23/10/2024 |
| 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="2"
Months="0"
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
|
We shall be recruiting the women undergoing MTP up to 24 weeks as well as beyond 24 weeks of gestation at the time of decision of MTP made and they will be followed up for details such as demographic data, indication of MTP, method of MTP, any advanced investigation done and any complications arising during the process. Aim is to interpret the kind of MTP practices after the amendment of MTP law |