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CTRI Number  CTRI/2025/08/093028 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of 2 methods for dilation of cervix four hours before operative hysteroscopy - Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S). 
Scientific Title of Study   Comparison of Efficacy of Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S) for Cervical Preparation four hours before Operative Hysteroscopy: A Double Blinded Randomized Controlled Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shyma Madniya 
Designation  Junior Resident MS Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  Old blackwell hostel JIPMER Campus Gorimedu Dhanvantari Nagar Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9912515013  
Fax    
Email  gethamidnow@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Murali Subbaiah 
Designation  Additional Professor Department of Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  2ND FLOOR Department of Obstetrics and Gynecology WOMEN AND CHILDREN HOSPITAL JIPMER Gorimedu Dhanvantari Nagar Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8940760837  
Fax    
Email  muralidraiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Murali Subbaiah 
Designation  Additional Professor Department of Obstetrics and Gynecology 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education And Research 
Address  2ND FLOOR Department of Obstetrics and Gynecology WOMEN AND CHILDREN HOSPITAL JIPMER Gorimedu Dhanvantari Nagar Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8940760837  
Fax    
Email  muralidraiims@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 
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 S MURALI  WOMEN AND CHILDREN HOSPITAL JIPMER  401 GYNECOLOGY WARD 3RD FLOOR WOMEN AND CHILDREN HOSPITAL JIPMER Gorimedu Dhanvantari Nagar Puducherry 605006
Pondicherry
PONDICHERRY 		 8940760837

muralidraiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE- INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  use of synthetic osmotic dilator ( dilapan-s ) 4 hours prior to operative hysteroscopy for cervical dilation.  Synthetic osmotic dilators may be more effective in achieving optimal cervical dilatation before operative hysteroscopy as compared to prostaglandin analogues like misoprostol1.Usually osmotic dilators are instilled for 12hours. Instillation of cervical dilators for 12 hours is not convenient as these procedures are usually done as day care procedures. Instillation of osmotic dilators for shorter duration (4h) may also be effective. Dilapan-S, a synthetic osmotic cervical dilator, has been reported to have advantages like faster onset of action and greater cervical dilation over Laminaria in several in vitro studies8 and studies done in pregnant women for cervical ripening9-12. Despite this, there is limited data on its use in non-gravid women undergoing operative hysteroscopy. 
Comparator Agent  vaginal Misoprostol 400 mcg 4 hours prior to operative hysteroscopy   Synthetic osmotic dilators may be more effective in achieving optimal cervical dilatation before operative hysteroscopy as compared to prostaglandin analogues like misoprostol1.Usually osmotic dilators are instilled for 12hours. Instillation of cervical dilators for 12 hours is not convenient as these procedures are usually done as day care procedures. Instillation of osmotic dilators for shorter duration (4h) may also be effective. Dilapan-S, a synthetic osmotic cervical dilator, has been reported to have advantages like faster onset of action and greater cervical dilation over Laminaria in several in vitro studies8 and studies done in pregnant women for cervical ripening9-12. Despite this, there is limited data on its use in non-gravid women undergoing operative hysteroscopy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details 
Women of age 18 years or more, scheduled for operative hysteroscopic procedures with 26F resectoscope.
 
 
ExclusionCriteria 
Details 
i. Known Cervical incompetence

ii. Contraindication to Misoprostol use like history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure

iii. Significant uterovaginal prolapse precluding the administration of vaginal tablets.

iv. Active vaginal infection or active pelvic inflammatory disease
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation 4hrs prior to operative hysteroscopy.  During the insertion of 26 F resectoscope-operative hysteroscope

AT 4 HOURS - following vaginal misoprostol or synthetic osmotic dilator dilapan S

 
 
Secondary Outcome  
Outcome  TimePoints 
To study the side effects & complications of Misoprostol & short term use of synthetic osmotic dilator (Dilapan).  during 4 HOURS The time period after inserting the drug or medical device to before shifting the patient to the operation theatre
 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/10/2025 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  on request mail to guide (muralidraiims@gmail.com)

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 30-09-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Comparison of efficacy of vaginal Misoprostol vs synthetic osmotic dilator Dilapan for cervical preparation four hours prior to operative hysteroscopy A Double blinded randomized controlled study.

 Primary outcome is to compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation4hrs prior to operative hysteroscopy 

Synthetic osmotic dilators may be more effective in achieving optimal cervical dilatation before operative hysteroscopy as compared to prostaglandin analogues like misoprostol. Usually osmotic dilators are instilled for 12hours. Instillation of cervical dilators for 12 hours is not convenient as these procedures are usually done as day care procedures. Instillation of osmotic dilators for shorter duration 4h may also be effective. 

There are only few studies, which have compared a synthetic osmotic dilator with Misoprostol for cervical dilatation 12 hours before operative hysteroscopy. However, there is no published study comparing the efficacy of Misoprostol and 4 mm Dilapan for 4 hours in cervical preparation in a non-gravid uterus. This study addresses this gap.


If proven superior to Misoprostol short term Dilapan S could be used routinely for cervical preparation.

 
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