FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081230 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 23/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [foleys with extra amniotic saline infusion/ foleys]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two (foleys and foley with extra amniotic saline infusion) methods for induction of labour pains in pregnant women who are admitted for delivery  
Scientific Title of Study   Induction of labor in women with unfavorable cervix: A randomised controlled study to assess the effectiveness of intracervical foley’s catheter with extra amniotic saline infusion vs only foley’s catheter  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amrusha Mangavilli 
Designation  Post graduate resident 
Affiliation  AIIMS Mangalagiri 
Address  Department of OBG AIIMS Mangalagiri Guntur-522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  9398872511  
Fax    
Email  mangavilliamrusha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vandana Kamatham 
Designation  Assistant Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of OBG AIIMS Mangalagiri Guntur-522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  9787424158  
Fax    
Email  dr.vandanakamatham@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amrusha Mangavilli 
Designation  Post graduate resident 
Affiliation  AIIMS Mangalagiri 
Address  Department of OBG AIIMS Mangalagiri Guntur-522503


ANDHRA PRADESH
522503
India 
Phone  9398872511  
Fax    
Email  mangavilliamrusha@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri 
 
Primary Sponsor  
Name  Amrusha Mangavilli 
Address  Department of OBG AIIMS Mangalagiri 
Type of Sponsor  Other [CENTRAL GOVERNMENT INSTITUTE] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amrusha Mangavilli  AIIMS Mangalagiri  Department of OBG AIIMS Mangalagiri
Guntur
ANDHRA PRADESH 
9398872511

mangavilliamrusha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  extra amniotic saline infusion  extra amniotic saline infusion will be given along with intracervical foleys catheter insertion in intervention group and foleys catheter alone in the control group 
Comparator Agent  foleys induction  Under strict aseptic precautions 22F foleys catheter will be inserted into cervix under direct visualization by holding the tip of the catheter with an artery forceps , bulb of the foleys catheter will be inflated with 20cc normal saline and the catheter will be gently pulled back so as to assure the tip of the catheter is beyond internal os and bulb is exactly at the level of internal os. Once the position of the catheter is confirmed the bulb will be further inflated with 40 cc of normal saline, a total of 60 cc of normal saline will be used for foley bulb inflation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women planned for induction of labor
Singleton gestation
Intact membrane.
Cephalic presentation.
Unfavourable cervix  
 
ExclusionCriteria 
Details  Women who are already in labour.
Previous c section
Previous history of any uterine surgeries (myomectomy, hysterotomy etc)
Non-reactive NST.
5. Low lying placenta / placenta previa/ vasa previa
Placental abruption.
Active genital herpes.
Malpresentation.
Contracted pelvis
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Post foley expulsion- improvement in bishops score
2. Requirement for further inducing agents post foley expulsion {misoprostol/pge2 gel/oxytocin}
3. Induction to entry into active phase of labor
4. Induction to delivery interval
 
BISHOP score more than 6 
 
Secondary Outcome  
Outcome  TimePoints 
1. Caesarean delivery rate
2. Incidence of chorioamnionitis
3. APGAR score at 1 & 5 mins
4. NICU admission rate
 
bishops score more than 6 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   06/03/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mangavilliamrusha@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

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

All the pregnant woman including both primigravida and multigravida who have been admitted for induction of labor with  no other contraindication for vaginal delivery will be assessed by their pre induction BISHOPS score

Women with score < 6 will be taken into study after satisfying all the inclusion and exclusion criteria and after taking a detailed history and written informed consent. (10)

Under strict aseptic precautions 22F foleys catheter will be inserted into cervix under direct visualization by holding the tip of the catheter with an artery forceps , bulb of  the foleys catheter will be inflated with 20cc normal saline and the catheter will be gently pulled back so as to assure the tip of the catheter is beyond internal os and bulb is exactly at the level of internal os.

Once the position of the catheter is confirmed the bulb will be further inflated with 40 cc of normal saline, a total of 60 cc of normal saline will be used for foley bulb inflation.

 

Once the foley bulb is inflated,500cc warm normal saline(0.9% isotonic normal saline at room temperature) will be infused at the rate of 60cc/hr into the extra amniotic space through the catheter port via an infusion pump and back flow of the saline will be prevented by knotting the catheter at the rear end at the end of infusion.

Then the catheter will be tied to the medial side of the thigh after creating the necessary traction.

After spontaneous expulsion of foley’s catheter or after removal of foleys catheter after 24 hours of insertion, Post induction BISHOP’S score will be assessed and further methods of induction like PGE2 gel/ misoprostol/oxytocin will be decided based on the score.

Only the guide/ co guide will do the pre and post induction BISHOPS scoring

Patient blinding cannot be done. But the assessor ( guide/co-guide) will be blinded. Pre and post induction BISHOP will be assessed by the same person.

Pharmacological agents will be used if post foleys bishops score still indicates an unfavorable cervix i.e., if the score is still ≤6, prostaglandins will be considered. If the score is ≥7 , oxytocin will be given for further induction(11)

Induction - delivery interval, mode of delivery (normal vaginal delivery/ instrumental delivery/ c section), maternal and neonatal complications will be noted.

 
Close