FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045885 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 23/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of two drugs(Dinoprostone gel and mifepristone)for labour pain stimulation 
Scientific Title of Study   SAFETY AND EFFICACY OF ORAL MIFEPRISTONE VERSUS INTRACERVICAL DINOPROSTONE GEL AS A CERVICAL RIPENING AGENT AMONG PREGNANT WOMEN REQUIRING LABOUR INDUCTION – A RANDOMIZED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPSRIROHINI 
Designation  1st year post graduate in M.S.obstetrics and gynaecology ESIC MC AND PGIMSR kknagar chennai 
Affiliation  ESIC MC PGIMSR, Chennai 
Address  B block 1st floor Department of obstetrics and gynaecology ESIC MC and PGIMSR Ashok pillar road K K Nagar Chennai 600078

Chennai
TAMIL NADU
600078
India 
Phone  7904041564  
Fax    
Email  rohinisri18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAnitha A M 
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESIC MC PGIMSR KKNAGAR CHENNAI  
Affiliation  ESIC MC PGIMSR, Chennai 
Address  B block 1st floor Department of obstetrics and gynaecology ESIC MC PGIMSR Ashok pillar road K K Nagar Chennai 600078

Chennai
TAMIL NADU
600078
India 
Phone  7299027672  
Fax    
Email  anithaam1982@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anitha A M 
Designation  ASSOCIATE PROFESSOR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ESIC MC PGIMSR KKNAGAR CHENNAI  
Affiliation  ESIC MC PGIMSR, Chennai 
Address  B block 1st floor Department of obstetrics and gynaecology ESIC MC PGIMSR Ashok pillar road K K Nagar Chennai 600078

Chennai
TAMIL NADU
600078
India 
Phone  7299027672  
Fax    
Email  anithaam1982@gmail.com  
 
Source of Monetary or Material Support  
B block 1st floor Department of obstetrics and gynaecology ESIC MC PGIMSR Ashok pillar road K K Nagar Chennai 600078  
 
Primary Sponsor  
Name  Dr P Srirohini 
Address  ESIC MC and PGIMSR K KNagar Chennai 600078  
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 P srirohini  ESIC MC and PGIMSR  B block 1st floor Department of obstetrics and gynaecology ESIC MC PGIMSR K KNagar Chennai 600078
Chennai
TAMIL NADU 		 7904041564

rohinisri18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O630||Prolonged first stage (of labor),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dinoprostone gel  Dinoprostone gel vaginally 0.5mg every 8 hours maximum 3 doses/till induction of labour 
Intervention  Mifepristone   Oral mifepristone tablet 200mg for induction of labour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Willing to participate
2. Primigravida
3. Singleton pregnancy,Cephalic presentation.
4. Gestational age 40+ weeks.
5. Maternal age>19years
6. No contraindications for prostaglandins or mifepristone.
7. No contraindication for vaginal delivery
8. Modified Bishop’s Score < 6
9. Intact membranes.
10.Women with history of 1 or 2 previous abortions. 
 
ExclusionCriteria 
Details  Breech presentation
Cephalopelvic disproportion
History of 3 or more abortions
Estimated fetal weight > 4.5 kg or < 2kg
Multigravida,Twin pregnancy
Obstetric complications like Diabetes ,Abruptio placenta or Placenta previa.
Abnormal fetal heart rate patterns.
Premature rupture of membranes.
Active genital infection.
Contraindication for mifepristone
Chorioamnionitis
Myoma or uterine anomalies
IUD’S
IVF Conception 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in bishop score   at 8, 16 and 24 hours after administration of the drug 
 
Secondary Outcome  
Outcome  TimePoints 
Induction to delivery interval,mode of delivery,,cesarean for failed induction ,any adverse events,maternal and fetal outcome  24 -48 hours 
 
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   Phase 2 
Date of First Enrollment (India)   30/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
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 stimulation of uterine contractions before the spontaneous onset of labour with or without ruptured membranes. Labour induction is usually carried out for maternal and fetal conditions. 

PGE2, PGE1 and Oxytocin are the most common pharmacological agents used for labour induction.

Prostaglandin E2(PGE2) is effective in achieving cervical ripening and also in activating myometrial contractility.

Mifepristone is a potent antiprogesterone and antiglucocorticoid Compound.It also increases uterine activity and causes cervical effacement and dilation and termination of pregnancy.

Mifepristone has an established role in termination of pregnancy during the early first and the second trimesters.
Recent researches done in India have shown mifepristone is effective as a cervical ripening agent in labour induction with higher rate of vaginal delivery with insignificant maternal and perinatal complications.4,5

Dinoprostone (PGE2) gel is also a effective cervical agent but it needs strict aseptic precautions,skill for intracervical insertion and requires refrigerator for storage whereas Oral Mifepristone is easy to administer,stable at room temperature and patient can remain ambulatory which is more convenient for the patients

Present study is being performed to determine the safety and efficacy of oral mifepristone and compare it with intracervical Dinoprostone gel as a cervical ripening agent in low risk singleton pregnant women who have completed 40weeks of pregnancy. 
 
Close