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CTRI Number  CTRI/2013/11/004151 [Registered on: 19/11/2013] Trial Registered Prospectively
Last Modified On: 14/11/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A STUDY FOR COMPARING THE EFFECT OF MIFEPRISTONE WITH MISOPROSTOL FOR INDUCTION OF LABOR  
Scientific Title of Study   A PROSPECTIVE DOUBLE BLIND RANDOMIZED CONTROL TRIAL COMPARING THE EFFECT OF MIFEPRISTONE WITH MISOPROSTOL FOR INDUCTION OF LABOR  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chanderdeep Sharma 
Designation  Senior Resident 
Affiliation  Dr RPGMC Kangra at Tanda (HP) 
Address  Department of Obstetrics & Gynecology, Dr RPGMC Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9218925471  
Fax    
Email  cdsharma2006@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Verma 
Designation  Proffessor & Head 
Affiliation  Dr RPGMC Kangra at Tanda (HP) 
Address  Deptt. of Obstetrics & Gynecology, Dr RPGMC Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418080404  
Fax    
Email  sureshsverma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chanderdeep Sharma 
Designation  Senior Resident 
Affiliation  Dr RPGMC Kangra at Tanda (HP) 
Address  Set No. 112, Vivekanand Hostel, Dr RPGMC Tanda


HIMACHAL PRADESH
176001
India 
Phone  9218925471  
Fax    
Email  cdsharma2006@gmail.com  
 
Source of Monetary or Material Support  
Government of H.P. 
 
Primary Sponsor  
Name  Govt of HP 
Address  Dr RPGMC Kangra at Tanda (HP) 
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 
Dr Chanderdeep Sharma  Dr RPGMC Kangra at Tanda (HP)  Labor ward, Deptt. of OBG, Dr Rajendra Prasad Government Medical college, Kangra at Tanda (HP)
Kangra
HIMACHAL PRADESH 		 9218925471

cdsharma2006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Committee, Dr RPGMC Kangra at Tanda (HP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  pregnant women for induction of labor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mifepristone 400 mg  Women randomized to this group will receive 400 mg of mifepristone and will be assessed after 24 and 48 hours for Bishop Score or spontaneous onset of labor. If at any time (24 hours or 48 hours) Bishop Score is ≥6, artificial rupture of membranes followed by oxytocin augmentation (if required) will be done, else after 48 hours else 25 µg of misoprostol every four hourly for a maximum of five doses will be given and if women do not go in to active labor, artificial rupture of membranes followed by oxytocin infusion will be done. 
Comparator Agent  placebo (2 tablets of common salt/ NaCl)  Women in group 2 will receive placebo (2 tablets of NaCl/ common salt) and will be assessed after 24 hours and 48 hours for Bishop score or spontaneous onset of labor. If at any time bishop score is ≥ 6, artificial rupture of membranes followed by oxytocin augmentation (if required ) will be done, else 25 µg of misoprostol every four hourly for a maximum of five doses will be given and if women do not go in to active labor, artificial rupture of membranes followed by oxytocin infusion will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women admitted with indications for induction of labor from gestation 37 to 42 weeks.
2. Induction can be postponed for 48 hours.
3. Bishop score ≤ 6.
4. Singleton pregnancy.
5. Vertex presentation.
6. Maternal age > 18 years.
 
 
ExclusionCriteria 
Details  Bishop score > 6.
2. Contraindications to vaginal delivery.
3. Oligohydramnios, IUGR.
4. Any previous cesarean section or uterine surgery.
5. Gravida ≥ 4.
6. Multiple pregnancies.
7. Severe pre eclampsia.
9. Renal failure, adrenal insufficiency, liver failure.
10. Patient on corticosteroid treatment.
11. Blood clotting disease or on anticoagulant therapy.
12. Intrauterine fetal death.
13. Any history suggestive of drug allergy.
14. Abruptio placentae
15. Non-reassuring fetal heart rate status.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Proportion of women entering labor after use of mifepristone alone after 24 & 48 hours   time from induction of labor to delivery 
 
Secondary Outcome  
Outcome  TimePoints 
• Proportion of women vaginally delivered in each group
• Proportion of women with cesarean section in each group
• Proportion of women with failed induction in either group
• Duration of labor in women in each group
• Need and amount of oxytocin required in each group
• Neonatal outcomes including ;
 Apgar score (1 min & 5 min)
 Need of phototherapy (if required; duration)
 Intensive care admission (if required)
 
 		 time from induction of labor to delivery 
 
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)   01/12/2013 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   100 pregnant women between 37-42 weeks gestation will be recruited after taking their informed consent and fulfilling inclusion and exclusion criteria. 50 women will receive mifepristone 400 mg ( 2tablets, 200 mg each) and will be assessed after 24 & 48 hours, if at any time bishop score is >/= 6 artificial rupture of membranes followed by oxytocin infusion (if required ) will be done, else after 48 hours induction of labor will be started with 25 micrograms of misoprostol each to be repeated four hourly to a maximum of 5 doses in 24 hours, to be followed by artificial rupture of membranes and oxytocin infusion ( if required). Other 50 women will receive placebo tablets (2 tablets of common salt/ NaCl each) and rest all will be done similar as in mifepristone group. These two groups will then be compared for proportion of women in labor after giving mifepristone/placebo, women with normal vaginal delivery, women with cesarean section, women with failed induction, duration of labor, need and amount of oxytocin and neonatal outcomes. 
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