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CTRI Number  CTRI/2022/04/042218 [Registered on: 27/04/2022] Trial Registered Prospectively
Last Modified On: 22/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Different methods for trying normal delivery  
Scientific Title of Study   “COMPARATIVE STUDY OF PERVAGINAL MISOPROSTOL, INTRACERVICAL FOLEY CATHETER, INTRACERVICAL DINOPROSTONE AS METHODS OF INDUCTION OF LABOUR AND MATERNAL AND FETAL OUTCOME” 
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  Gadag Institute of Medical Sciences Gadag
District hospital premises Mallasamudra
Gadag
KARNATAKA
582101
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  Gadag Institute of Medical sciences Gadag
District hospital premises Mallasamudra
Gadag
KARNATAKA
582101
India 
Phone  9448001054  
Fax    
Email  hanumantvn.1210@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Uppar 
Designation  Junior Resident 
Affiliation  Gadag Institute of Medical Sciences, Gadag 
Address  Gadag Institute of Medical Sciences, Gadag
District hospital premises Mallasamudra
Gadag
KARNATAKA
582101
India 
Phone  9448001054  
Fax    
Email  praveenuppar0271995@gmail.com  
 
Source of Monetary or Material Support  
GIMS Gadag Medical College 
 
Primary Sponsor  
Name  GIMS Gadag 
Address  GIMS Gadag 
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 
Hanumant v nipanal  Gadag Institute of Medical Sciences, Gadag   Department 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 GIMS Gadag  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, (2) ICD-10 Condition: O618||Other failed induction of labor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dinoprostone gel  Patient lied on supine position with legs semiflexed. Bishops score assessed.Dinoprostone 2.5ml of 0.5 mg injected into the cervical canal below the internal osunder aseptic precautions . Watch for uterine contractions and featal heart rate. Reassess the bishops score after 6 hours.Dinoprostone can be repeated 6 hourly for maximum 3 dose. 
Intervention  Foley catheter   Under aseptic precautions bishops score assessed. Foley catheter of No.18 introduced in the cervical canal. Foley catheter balloon is filled with 50 ml of normal saline. Catheter is tagged to right thigh. Will be waited for 24 hour’s to auto expell or deflate the balloon. Reassess the bishops score.  
Comparator Agent  Misoprostol tablet  Patient lied on supine position with legs semiflexed. Bishops score assessed. Tablet misoprostol 25 microgram pervaginally put in the posterior fornix. Watch for uterine contractions and featal heart rate. Reassess the bishops score after 4 hours. Dose can be repeated 4 hourly for maximum of 6 dose. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patient with
1. singleton,
2. cephalic,
3. term gestation,
4. intact membranes,
5. live fetus,
6. absence of uterine contractions,
7. Informed written consent
 
 
ExclusionCriteria 
Details  1. Pregnancy induced hypertension,
2. fetal distress,
3. previous cesarian section,
4. uterine surgery,
5. intrauterine growth reduction ,
6. malpresentation ,
7. oligohydramnios,
8. polyhydramnios
9. diabetic mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
rate of vaginal delivery  24 hours after induction
 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of cesarean section
 		 48 hours of induction 
 
Target Sample Size   Total Sample Size="273"
Sample Size from India="273" 
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)   28/04/2022 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Nil

  2. What additional supporting information will be shared?
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 21-04-2022 and end date provided 21-05-2023?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Induction of labour involves the artificial stimulation of uterine contractions with the aim to achieve safe vaginal delivery and performed approximately 15 percentage of all pregnancy. Induction of labour has two components. Cervical ripening and stimulation of uterus to achieve dilatation of cervix and delivery of fetus .

Decision   of induction of labour is taken for the benefits are more than risks of continuation of pregnancy.

Foley catheter induction. acts by exerting pressure into cervical canal and seperates decidua and stimulate the local release of prostaglandins. Foley catheter is most commonly used in current clinical practice. There is reduced risk of hyperstimulation and fetal distress with Foley catheter induction of labour.

Pharmacological methods being used are prostaglandins like Dinoprostone and Misoprostol.

Presently misoprostol gain the popularity due to the advantages like low cost stability of drug at room temperature, easy handling, storage, easy administration and good efficiency .

 

The purpose of this study is to compare the safety and success of pervaginal misoprostol, intracervical dinoprostone, intracervical Foley catheter for induction of labour.

 

 
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