CTRI Number |
CTRI/2022/09/046065 [Registered on: 30/09/2022] Trial Registered Prospectively |
Last Modified On: |
24/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Methods of abortion in second trimester |
Scientific Title of Study
|
comparison of efficacy of misoprostol versus Foley and misoprostol combination in second trimester medical termination of pregnancy |
Trial Acronym |
MTP |
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 |
R.No. 22
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 |
R.No. 22
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 Aamani K |
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 |
8762171027 |
Fax |
|
Email |
aamanikuruba@gmail.com |
|
Source of Monetary or Material Support
|
Gadag Institute Of Medical Sciences
District hospital premises Mallasamudra Gadag
Karnataka 582103 |
|
Primary Sponsor
|
Name |
Dr Hanumant V Nipanal |
Address |
R.No. 22
dept. of OBG GIMS
Gadag |
Type of Sponsor |
Other [self] |
|
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 |
Dept of obstetrics and gynecology
Room no 23 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: 1||Obstetrics, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
All cases those who will fulfil indication of Medical Termination of Pregnancy
for second trimester up 24 weeks, as per guidelines of MTP Act of 1971 and amended in 2021.
|
|
ExclusionCriteria |
Details |
1. Scarred uterus
2. Ectopic pregnancy
3. Grand multipara
4. Contraindications to misoprostol and Foleys catheter
|
|
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 products of conception |
24hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
complications (if any) |
48 hours |
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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 4 |
Date of First Enrollment (India)
|
15/09/2023 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not applicable |
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 by any means before the fetus is viable. Abortions
will be done up to 24 weeks pregnancy Medical Termination of Pregnancy [MTP]
Act, enacted by the Indian parliament came into effect from 1 April 1972 and
new amendment of 2021. Presently MTP can be performed on Medical,
Eugenic, Humanitarian and Social grounds, Terminating
a pregnancy in 2nd trimester is a bigger danger to both
the mother and foetus as compared to a first trimester pregnancy. A majority of
the abortions in second trimester are carried out because of foetal
abnormalities and sometimes maternal complications. Out of the different
methods of termination, medical methods are believed to be safer and more
effective as compared to the surgical approaches. Intravaginal misoprostol and
intracervical Foley catheter are the most preferred methods. Few researchers
claim intravaginal misoprostol whereas others believe intracervical Foley
catheter to be more effective and few researches have speculated that if the
both methods are combined will give best results.
Hence,
our study is aimed to compare the efficacy of misoprostol versus combination of
Foley catheter and misoprostol in second trimester medical termination of
pregnancy. OBJECTIVES: To Compare
the efficacy of misoprostol versus Foley and misoprostol combination in second
trimester medical termination of pregnancy.
Data
collection method: Pregnant women attending the
OPD of GIMS for second trimester MTP that is 12+1 weeks to 24 weeks of
gestation and who will fulfil inclusion and exclusion criteria were selected
for the study. Ultrasound examination was used for the date confirmation and
their eligibility to enter into the study. Selected patients were admitted to
obstetrics ward and procedure will be planned. Complete evaluation of each patient
was done at admission. Detailed history as well as clinical findings of medical
and obstetric examination was recorded.
|