| CTRI Number |
CTRI/2013/03/003488 [Registered on: 15/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Mifepristone along with Misoprostol for medical abortion in second trimester of pregnancy. |
|
Scientific Title of Study
|
To study the safety and efficacy of use of Mifepristone along with Misoprostol for medical termination of pregnancy in second trimester (12-20weeks) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpa Junghare |
| Designation |
Professor and HOD(OBGY) |
| Affiliation |
Dr Panjabrao Deshmukh Memorial Medical College and Research Institute |
| Address |
Ajinkya Near D mart University road Camp
Amravati
Amravati
MAHARASHTRA
444602
India |
| Phone |
91-9922445937 |
| Fax |
91-721-2661742 |
| Email |
pushpasj4@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayali Jahagirdar |
| Designation |
Assistant Professor |
| Affiliation |
Dr Panjabrao Desmukh Memorial Medical College and Research Institute |
| Address |
12 Vyankatesh Gulmohor colony
Camp Amravati
Amravati
MAHARASHTRA
444602
India |
| Phone |
91-9922914788 |
| Fax |
91-721-2661742 |
| Email |
rupasi2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puspa Junghare |
| Designation |
Prof and HOD (OBGY) |
| Affiliation |
|
| Address |
Ajinkya Near D-Mart University road Camp Amravati
Amravati
MAHARASHTRA
444602
India |
| Phone |
91-9922445937 |
| Fax |
91-721-2661742 |
| Email |
pushpasj4@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of OBGY DrPanjabrao Deshmukh Memorial Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Pushpa Junghare |
| Address |
Ajinkya Near D-Mart University road Camp
Amravati 444602
Maharashtra |
| Type of Sponsor |
Other [Professor and HOD(OBGY)] |
|
|
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 Sayali Jahagirdar |
Department of OBGY |
Dr Panjabrao Deshmukh Memorial Medical College and Research Institute Shivaji Nagar Amravati 444602
Amravati
MAHARASHTRA |
91-9922914788
91-721-2661742
rupasi2001@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Dr P.D.M.Medical College,Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women opting for Medical Termination of pregnancy in second trimester(12-20weeks), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mifepristone Misoprostol |
All women opting to undergo medical termination of pregnancy(12-20weeks)will receive 200mg of oral Mifepristone along with 400mcg of Misoprostol vaginally followed by 200mcg of Misoprostol vaginally every 4 hours till active uterine contractions are established |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women wanting to undergo second trimester medical termination of pregnancy (12-20weeks) |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to Mifepristone or Misoprostol
Women with medical renal disease,liver disease
Women with heart disease
Hb less than 8gm% |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of use of Mifepristone along with Misoprostol for second trimester medical termination of pregnancy(12-20weeks) |
12-20weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)addional intervention required
2)estimation of blood loss |
24 hours after last dose of misoprostol |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Combination of Mifepristone and Misoprostol has been successfully used for medical termination of pregnancy upto 12 weeks.In this study we are using single dose Mifepristone and Misoprostol for second trimester termination of pregnancy (12-20 ) weeks. Till date we have enrolled 48 cases in our study. Induction to abortion interval was approximately 12-16 hours. No major complications were seen.
|