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CTRI Number  CTRI/2025/03/082243 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 16/02/2025
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 Randomized controlled Trial of PGE2 gel versus Transcervical Foley Catheter for Induction of Labor in Women with Previous Cesarean Section  
Scientific Title of Study   A Randomized controlled Trial of PGE2 gel vs Transcervical Foleys Catheter for Induction of Labor in Women with Previous Cesarean Section  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya  
Designation  Junior resident  
Affiliation  AIIMS JODHPUR  
Address  3rd floor , Medical college Department of Obstetrics & Gynaecology AIIMS Jodhpur
Ward no 17 old tehsil road , near water works , arya nagar , jhajjar , Haryana Pincode - 124103
Jodhpur
RAJASTHAN
342005
India 
Phone  8930902843  
Fax    
Email  priyagujjar11111@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Manu Goyal  
Designation  Additional Professor  
Affiliation  AIIMS JODHPUR  
Address  3rd floor Medical college , Department of Obstetrics & Gynaecology AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9971833603  
Fax    
Email  drmanu_8@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Priya  
Designation  Junior resident  
Affiliation  AIIMS JODHPUR  
Address  3rd floor Department of Obstetrics & gynaecology Medical college , AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8930902843  
Fax    
Email  priyagujjar11111@gmail.com   
 
Source of Monetary or Material Support  
AIIMS JODHPUR  
 
Primary Sponsor  
Name  AIIMS Jodhpur  
Address  Department of Obstetrics and Gynaecology , 3rd floor , medical college , AIIMS JODHPUR , Rajasththan Pin code - 342005 
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 PRIYA  AIIMS JODHPUR   DEPARTMENT OF OBSTETRICS & GYNAECOLOGY , 3RD FLOOR , MEDICAL COLLEGE , AIIMS JODHPUR
Jodhpur
RAJASTHAN 
8930902843

priyagujjar11111@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS JODHPUR INSTITUTIONAL ETHICAL COMMITTEE  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: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Induction by PGE2 gel   Induction of labor by Foleys catherter compared to Induction of labour by PGE 2 gel in Women with prevous 1 LSCS  
Intervention  Induction OF LABOUR by Foleys catheter   Induction of labor by Foleys catherter compared to Induction of labour by PGE 2 gel in Women with prevous 1 LSCS  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women with history of previous one Lower segment cesarean section with
Singleton pregnancy
Gestational age more than 34 weeks
Cephalic presentation
Bishop score of less than or equal to 6
Reactive Non stress test
Patients willing for Vaginal delivery after previous one LSCS
 
 
ExclusionCriteria 
Details  Contraindication to use of prostaglandins like history of bronchial asthma
Previous uterine surgery other than Lower segment cesarean section
Placenta Previa
Active genital tract infection
Abnormal fetal heart rate pattern
Allergy to latex
Patient refusal for consent of induction or vaginal delivery
Any other contraindication for TOLAC
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the change in Bishop score after 12 hours of induction with PGE 2 gel and transcervical Foley catheter in women with previous one LSCS.
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare mode of delivery between PGE2 gel versus Foleys catheter used for induction of labor

 
2 years  
To compare the rate of fetal distress between PGE2 gel versus transcervical Foley catheter for induction of labor in women with previous one LSCS  2 years  
To compare induction to delivery interval between PGE 2 gel versus transcervical Foley catheter  2 years  
To compare maternal complications like uterine tachysystole uterine rupture between PGE2 gel & Foley catheter useof labor in used for induction of labor in women with previous 1 LSCS  2 years  
To compare APGAR score between PGE2 & Foley catheter used for induction of labor in women with previous 1 LSCS   2 years 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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/ Phase 3 
Date of First Enrollment (India)   20/03/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Repeat cesarean section exposes women to multiple risks like blood loss, injury to the urinary tract, infections, adherent placenta, and cesarean hysterectomy. Vaginal birth after cesarean section is a procedure that can be offered to women who have had a prior cesarean section.

Induction of labor is often taken up in the interest of the mother and the fetus. Labor induction in the presence of an unfavorable cervix is associated with labor dystocia and a higher incidence of repeat cesarean section. Hence, the use of cervical ripening agents is beneficial. Induction with Foley catheter is a safe, inexpensive, and reliable method of cervical ripening, with a low risk of uterine tachysystole and fetal distress but poses a potential danger of accidental rupture of membranes, cord prolapse, chorioamnionitis, and pyrexia because of infection.5 While PGE 2 gel  has also been proven to be effective for cervical ripening agents with a gradual onset of labor with the advantage of single application. Many studies that have evaluated cervical ripening with prostaglandin E2 (PGE2) insert have shown conflicting results and in the absence of conclusive studies, many countries continue to use PGE2 for induction of labor.

Intracervical Foley catheter has been proven efficient in achieving cervical ripening and successful labor with reduction in latent phase of labor and total delivery time without increasing the rate of cesarean section, uterine tachysystole, and uterine rupture. Considering the good performance of maternal and neonatal outcomes, the intracervical Foley catheter has been suggested  as a better choice for preinduction cervical ripening and induction of labor in women with previous cesarean sections in resource-limited settings.

 

 

 

Therefore, we decided to conduct a Randomized controlled trial   at the setting of AIIMS Jodhpur to compare the effectiveness and safety profile of PGE2 gel  with intracervical Foley’s catheter for ripening of cervix and induction of labor in women with previous 1 lower segment cesarean section

 Sample size has been calculated to be62 patients (with31 patients in each group) considering alpha of 0.05 ,90% power and 20% attrition rate. Patients will be selected as per inclusion and exclusion criteria and preinduction  workup will done followed by enrollment and consent .  Group 1 and Group 2 will continue to be compared even after achieving  of primary objective of study (difference in change of Bishop score between PGE2 gel and Foleys catheter ).   Various parameters like Bishop score , presence of fetal distress , induction to delivery interval , mode of delivery , Apgar score will be noted and compared between the two methods of induction of labor .    All the results will be evaluated statistically and whether any significant difference present or not will be noted. The entire study will be performed   as per  the ethical guidelines and monitoring and treatment will be  done as per standard hospital policy .


 
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