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CTRI Number  CTRI/2019/12/022565 [Registered on: 30/12/2019] Trial Registered Prospectively
Last Modified On: 26/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “A COMPARATIVE STUDY OF EFFECTIVENESS AND SAFETY OF DRUG ABC AND XYZ FOR ARTIFICIAL ONSET OF LABOUR”  
Scientific Title of Study   “A COMPARATIVE STUDY OF EFFECTIVENESS AND SAFETY OF INTRAVAGINAL MISOPROSTOL(PGE1) WITH INTRACERVICAL DINOPROSTONE (PGE2)GEL FOR INDUCTION OF LABOUR”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shital  
Designation  1st year resident,government medical college bhavanagar. 
Affiliation  Sir T general hospital and government medical college bhavnagar 
Address  804,PG2 HOSTEL,sir T hospital and government medical college bhavangar, Department of obstetrics and gyneacology, Gopinath maternity home.
103/A,block no. 5,Mayur flat,street no. 6,nirmalnagar,bhavnagar. Pin code no. 364001
Bhavnagar
GUJARAT
364001
India 
Phone  9898094744  
Fax    
Email  akshaychalaliya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipti C Parmar 
Designation  Associate professor,Dep of Obstetrics and gynaecology,government medical college bhavanagar. 
Affiliation  Sir T general hospital and government medical college bhavnagar 
Address  Department of obstetrics and gyneacology E-304, Doctors Quarter, Opp. A Division Police Station, Jail Road, Bhavnagar-364001, Gujarat.
Department of obstetrics and gyneacology E-304, Doctors Quarter, Opp. A Division Police Station, Jail Road, Bhavnagar-364001, Gujarat.
Bhavnagar
GUJARAT
364001
India 
Phone  9925021608  
Fax    
Email  kda2308@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shital  
Designation  1st year resident,givernment medical college bhavanagar. 
Affiliation  Sir T general hospital and government medical college bhavnagar 
Address  Department of Obstetrics and gyneacology 804,PG2 HOSTEL,sir T hospital and government medical college bhavangar
Department of obstetrics and gyneacology 103/A,block no. 5,Mayur flat,street no. 6,nirmalnagar,bhavnagar. Pin code no. 364001
Bhavnagar
GUJARAT
364001
India 
Phone  9898094744  
Fax    
Email  akshaychalaliya@gmail.com  
 
Source of Monetary or Material Support  
Dr. Shital chalaliya Resident in obstetrics and gyneacology department, gopinath maternity home, Government medical college and sir t general hospital Bhavnagar 
 
Primary Sponsor  
Name  Sir T general hospital and goevrnment medical college bhavangar 
Address  Dr.hemantkumar veidya road,jain road,bhavnagar. 
Type of Sponsor  Government medical college 
 
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 
Shital chalaliya  Gopinath maternity home, sir T general hospital nadi government medical college bhavangar  Dr. Hemntkumar vidya road, jail road bhavnagar
Bhavnagar
GUJARAT 		 9898094744

akshaychalaliya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board,sir T genaral hospital and government medical college bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Misoprostol(PGE1), Dinoprostone(PGE2)   Misoprostol (15-deoxy-16-hydroxy-16 methyl-PGE1) was the first synthetic prostaglandin analogue to be made available for the treatment of peptic ulcer. Misoprostol is available as 50, 100, 200 microgram tablets. It is stable at room temperature ,comparatively cheaper and can be used via several routes(oral,vaginal,sublingual,buccal ,rectal). In primigravida 50 ug misoprostol at interval of 4 hours and in multigravida 25ug misoprostol at interval of 4 hours. Dinoprostone (PGE2) is a synthetic preparation of naturally occurring prostaglandin E2. PGE 2 gel is available in 2.5 ml syringe for an intracervical application of 0.5mg of Dinoprostone. It shoud be kept in refrigerator at 2° to 8° c temperature. Dinoprostone gel 0.5gm intracervical at interval of 6hours in both primigravida and multigravida 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women with >37weeks of gestation with indication of induction of labour 
 
ExclusionCriteria 
Details  Contracted pelvic or cephalopelvic dispropotion,multifetal dispropotion,chromic medical disease,gluoma,asthma,previous scar on uterus 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare induction delivery interval with intravaginal misoprostol and intracervical dinoprostone gel  Time of admission to postpartam 6week 
 
Secondary Outcome  
Outcome  TimePoints 
To comapre outcome of induction of labour
To comapre fetomaternal outcome 		 Admission to postpartam 6week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/01/2020 
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   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Induction of labour is artificial intiation of uterine contraction prior to theire spontaneous onset leading toprogressive effecment and dilatation of cervix and delivery of the baby.
Indction of labour indicated when benefits to mother and fetus outweighs  those of pregnancy continuation.
My study is to comapare effictiveness and safety of intravaginal misoprostol and intracervical dinoprostone gel for induction of labour 



 
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