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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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