| CTRI Number |
CTRI/2025/08/093310 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative Study Between Antiadhesion Barriers To Prevent Intrauterine Adhesions After Hysteroscopy |
|
Scientific Title of Study
|
A Comparative Study Of Hyaluronic Acid Gel Vs Intrauterine Device For Prevention Of Intrauterine Adhesions Following Operative Hysteroscopy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaikh Muneeba |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Obsetrics and Gynecology Department, Jawaharlal Nehru Medical college, Sawangi Meghe Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9359529843 |
| Fax |
|
| Email |
skmuneeba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neema S Acharya |
| Designation |
Professor And Head of the department |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Obsetrics and Gynecology Department, Jawaharlal Nehru Medical college, Sawangi Meghe Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9326692511 |
| Fax |
|
| Email |
neemasacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaikh Muneeba |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Obsetrics and Gynecology Department, Jawaharlal Nehru Medical college, Sawangi Meghe Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9359529843 |
| Fax |
|
| Email |
skmuneeba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, Sawangi Meghe Wardha 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Muneeba Shaikh |
Acharya Vinoba Bhave Rural Hospital |
Obstetrics and Gynecology Department, Datta Meghe Institute Of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
9359529843
skmuneeba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N856||Intrauterine synechiae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic Acid Gel |
It is believed to create a protective barrier in the uterus, reducing trauma and preventing the formation of adhesions during the healing process after hysteroscopic surgery. |
| Comparator Agent |
Intrauterine Device (IUD)
|
An IUD inserted into the uterus after surgery may physically prevent the uterine walls from adhering to each other, thus reducing the risk of adhesion formation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
Scheduled for operative hysteroscopy (e.g., myomectomy, polypectomy, or endometrial resection) due to intrauterine pathology.
Informed consent obtained.
|
|
| ExclusionCriteria |
| Details |
Women with active pelvic infections, uterine cancer, or other contraindications to hysteroscopic surgery or IUD placement.
Women with a history of severe uterine malformations or previous major uterine surgery.
Pregnant or breastfeeding women.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of intrauterine adhesions (IUAs), with sub-outcomes including the recurrence of adhesions, fertility outcomes, patient discomfort, and satisfaction |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
24/08/2025 |
| 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="0"
Months="6"
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
|
Intrauterine adhesion (IUA) or Asherman’s
syndrome, are defined as the replacement of stroma with fibrous tissue, and of
the glands with inactive cub-columnar endometrial epithelium. IUAs often occur after damage to the
endometrium and its prevalence varies widely by the type intrauterine procedure
that causes the damage. IUA is associated with impaired
reproductive outcomes following both natural conception and assisted
reproduction technology. An ideal treatment for IUAs involves
dissecting the adhesions to restore the shape and volume of the uterine cavity,
and to prevent adhesion reformations. Hysteroscopic adhesiolysis has
become the standard treatment choice for IUAs management. However, potential
damage caused by this surgery may lead to an adhesion-prone condition of the
endometrium. |