| CTRI Number |
CTRI/2022/04/042164 [Registered on: 26/04/2022] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Different methods for trying vaginal delivery |
|
Scientific Title of Study
|
Comparision of Misoprostol versus sequential administration of Mifepristone and Misoprostol in Medical Termination of Pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hanumant V Nipanal |
| Designation |
Associate professor |
| Affiliation |
Gadag Institute of Medical Sciences,Gadag |
| Address |
dept. Of OBG
GIMS Gadag
District hospital premises Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
9448001054 |
| Fax |
|
| Email |
hanumantvn.1210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hanumant V Nipanal |
| Designation |
Associate professor |
| Affiliation |
Gadag Institute of Medical Sciences,Gadag |
| Address |
dept. Of OBG
GIMS Gadag
District hospital premises Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
9448001054 |
| Fax |
|
| Email |
hanumantvn.1210@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetha D |
| Designation |
Junior resident |
| Affiliation |
Gadag Institute of Medical Sciences,Gadag |
| Address |
dept. Of OBG
GIMS Gadag
District hospital premises Mallasamudra Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
9448001054 |
| Fax |
|
| Email |
shwethad3003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gadag Institute of Medical Sciences ,Gadag karnataka |
| GIMS govt hospital and department of medical education karnataka |
|
|
Primary Sponsor
|
| Name |
GIMS Gadag |
| Address |
GIMS Gadag |
| 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 Hanumant V Nipanal |
Gadag Institute of Medical Sciences, Gadag |
room number 37
dept. of OBG
Gadag
KARNATAKA |
9448001054
hanumantvn.1210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethical Committee Gadag Institute Of Medical Sciences, Gadag |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O046||Delayed or excessive hemorrhage following (induced) termination of pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All cases those will fulfil indication of Medical Termination of Pregnancy, as per guidelines of MTP Act of 1971. |
|
| ExclusionCriteria |
| Details |
Scarred uterus
Ectopic pregnancy
Grand multipara
Contraindications to misoprostol and mifepristone
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| complete expulsion of product of conception within 24hrs of the first dose of misoprostol |
complete expulsion of product of conception within 24hrs of the first dose of misoprostol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| induction abortion interval will be measured from the time of administration of first dose of misoprostol to the time of complete abortion. The need of analgesics and volume of blood loss will be estimated clinically. |
after 24 hours induction |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
abortion is defined as termination of pregnancy before fetus is viable. There are medical as well as surgical methods. medical methods include misoprostol , mifepristone, gemeprost etc. Surgical methods include menstrual regulation, vaccum aspiration, dilation and curratage and hysterotomy or hysterectomy. But surgical methods have complications like hemorrhage, perforation and infection. Medical abortion has potential advantage over the surgical complications. sequential administration of mifepristone followed by misoprostol has shown superior to the misoprostol alone. Hence present study is undertaken to evaluate the efficacy of mifepristone followed by misoprostol versus misoprostol alone. |