| CTRI Number |
CTRI/2022/09/045721 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A trial comparing the duration of second trimester abortion using two different doses of the same drug.†|
|
Scientific Title of Study
|
"A randomized control trial in second trimester termination of pregnancy with two different regimes" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVaishnavi Rajaraman |
| Designation |
3rd year Resident |
| Affiliation |
Amrita Institute of Medical sciences, Cochin |
| Address |
A-Block, Tower 4-0
Department of obstetrics & gynecology
Amrita institute of medical sciences Edapally, Cochin
Ernakulam
KERALA
682041
India |
| Phone |
9790884198 |
| Fax |
|
| Email |
rr.vaishnavir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudha S |
| Designation |
Professor & Unit chief, dept of OBG |
| Affiliation |
Amrita Institute of Medical sciences, Cochin |
| Address |
Tower 4-0, A Block,
Department of obstetrics and gynaecology, AIMS, Cochin
Ernakulam
KERALA
682041
India |
| Phone |
9388467844 |
| Fax |
|
| Email |
drsudhakishore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVaishnavi Rajaraman |
| Designation |
3rd year Resident |
| Affiliation |
Amrita Institute of Medical sciences, Cochin |
| Address |
A-BLOCK, Tower 4-0
Department of obstetrics & Gynecology
Amrita Institute of medical sciences
Edappally, Cochin
Ernakulam
KERALA
682041
India |
| Phone |
9790884198 |
| Fax |
|
| Email |
rr.vaishnavir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences, cochin |
|
|
Primary Sponsor
|
| Name |
Amrita Vishwa Vidyapeetham |
| Address |
AIMS, PONEKKARA
682041 |
| 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 |
| VAISHNAVI R |
Amrita Institue of medical sciences |
A-Block, Tower 4-0
Department of obstetrics and gynaecology
Amrita institute of medical sciences
Edappally, Cochin
682024
Ernakulam
KERALA |
9790884198
rr.vaishnavir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Amrita institute of medical sciences |
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 |
MIFEPRISTONE |
Mifepristone as a single dose 200mcg per oral STAT |
| Intervention |
Mifepristone |
Mifepristone as two doses 200mcg once daily for two days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients who will be admitted and treated for second -trimester abortions, induced abortions between 12 weeks to 20 weeks of gestation
|
|
| ExclusionCriteria |
| Details |
Patients having miscarriages before 12 weeks of gestation. 
Patient who delivered or terminated after 20 weeks 1 day. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Induction to expulsion interval in second trimester based on induction regimes. |
From the time of drug administration to expulsion ( Within 24-72 hours ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
En-Sac expulsion of products
Need for evacuation
Duration of hospital stay
Pain scale assessment
Patient satisfaction |
patient admission to discharge |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
21/09/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Second trimester abortion defines the miscarriages that are happening between 13 weeks and 20 weeks of gestation. It is an important component of the comprehensive women’s health care.
- The data regarding second trimester MTP is still under reported. Also not all centres offer services more than 20 weeks of gestation.
- We intend prospectively to recruit about 48 patients presenting to our department for second trimester termination, try mifegest as single dose and mifegest as two doses and analyse the induction to expulsion interval.
|