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CTRI Number  CTRI/2024/02/062843 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison of PGE2 Gel with Foleys catheter to induce labour in term pregnancy. 
Scientific Title of Study   Comparison of PGE2 gel and trans cervical Foley’s single balloon catheter for induction of labor in term pregnancy: An Open labelled 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  SUPRIYA 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  AIIMS PATNA, Obstetrics and Gynecology department, Room no 242, Patna 801507, Bihar

Patna
BIHAR
801507
India 
Phone  7903362610  
Fax    
Email  supriya10298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sangam Jha 
Designation  Associate Professor 
Affiliation  AIIMS PATNA 
Address  AIIMS PATNA, Obstetrics and Gynecology Department, Room No. 242

Patna
BIHAR
801507
India 
Phone  9827388001  
Fax    
Email  sangam.jha78@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUPRIYA 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Room No 107, Hostel No 4 , AIIMS PATNA, Patna 801507, Bihar

Patna
BIHAR
801507
India 
Phone  7903362610  
Fax    
Email  supriya10298@gmail.com  
 
Source of Monetary or Material Support  
Aiims patna 
 
Primary Sponsor  
Name  all india institute of medical sciences patna 
Address  Phulwarisharif Patna Bihar 
Type of Sponsor  Research institution and hospital 
 
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 Supriya  AIIMS PATNA  All India Institute of Medical Sciences Patna, Obstetrics and gynecology, Room no 242 ,801507
Patna
BIHAR 		 7903362610

supriya10298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA, institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Foleys catheter   Foleys catheter as an induction agent for induction of labour within 18 hours. 
Comparator Agent  PGE2 Gel  PGE2 gel as an induction agent for total duration of 18 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Antenatal female with ≥ 37 weeks of gestation
2. Singleton pregnancy
3. Cephalic presentation
4. Bishop’s score ≤ 3
5. Intact membranes
6. Cases where conditions were fulfilled for vaginal delivery. 
 
ExclusionCriteria 
Details  1. Multiple pregnancy
2. Bishop’s score less than equal to 3.
3. Malpresentation
4. Absent membranes
5. Antepartum haemorrhage
6. Previous uterine scar
7. Acute vaginal infection at time
8. Any Contraindication to vaginal delivery
9. Contraindication to drug (PGE2 gel) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement of Bishops score more than equal to 6   after 18 hours of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
time interval from induction to active labour  10 hours 
time interval from induction to delivery  24 hours 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 3/ Phase 4 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/02/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Foley’s transcervical balloon catheter is yet to be explored for its full potential as a sole
agent for induction of labour at term (≥37 weeks of gestation), specially in a non-scarred
uterus. If foley’s efficacy comes out as non-inferior in comparison to pharmacological agent
like PGE2 gel for induction of labour, it can be very useful in a low resource setting.
PGE2 gels have been reported to cause various side effects, most common of them being,
uterine hyperstimulation (2.5%), abdominal discomfort (2.0%), Gastrointestinal side effects
like diarrhea, nausea and vomiting (1%), headache (0.5%) and fetal heart rate changes
(5.7%) .On the contrary, no incidence of aberrant fetal heart rate patterns occurred during
preinduction cervical ripening using foley’s single balloon transcervical catheter. In addition
to this, Foley’s is relatively an inexpensive means for induction. 

Foley’s balloon catheter has been proven to be a successful agent of induction in a scarred
uterus by various studies, 
However, very few studies have evaluated the role of Foley’s catheter as an inducing agent
in non-scarred uterus. We aim to compare the efficacy of foley’s catheter with intracervical
Prostaglandin gel as an inducing agent in women at term pregnancy with non-scarred uterus.
 
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