| CTRI Number |
CTRI/2020/10/028198 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
14/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of various types of sonography tests for heavy menstrual bleeding |
|
Scientific Title of Study
|
Comparative study of saline hysterosonography and vaginal ultrasonography in evaluation of Menorrhagia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonal tahaliyani |
| Designation |
Post graduate |
| Affiliation |
Vinayaka missions medical college karaikal |
| Address |
Department of obgy
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8275244155 |
| Fax |
|
| Email |
sonaltahaliyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B Chakravorty |
| Designation |
Professor |
| Affiliation |
Vinayaka missions medical college and hospital karaikal |
| Address |
Department of obgy
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443338459 |
| Fax |
|
| Email |
Drakshay.dhaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B Chakravorty |
| Designation |
Professor |
| Affiliation |
Vinayaka missions medical college and hospital karaikal |
| Address |
Department of obgy
Vinayaka missions medical college and hospital
Keezhakasakudimedu
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443338459 |
| Fax |
|
| Email |
Drakshay.dhaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions medical college karaikal |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions medical college karaikal |
| Address |
Department of obgy
Vinayaka missions medical college karaikal |
| Type of Sponsor |
Private medical college |
|
|
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 Sonal tahaliyani |
Department of OBGY |
Vinayaka missions medical college and hospital karaikal 609609
Karaikal
PONDICHERRY |
8275244155
Sonaltahaliyani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VINAYAKA MISSION RESEARCH FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
51.00 Year(s) |
| Gender |
Female |
| Details |
Patients with abnormal uterine bleeding in reproductive and perimenopausal age group |
|
| ExclusionCriteria |
| Details |
1.Patients suspected to have endometrial carcinoma
2.Patients with pelvic inflammatory disease
3.Patients with possibility of pregnancy
4.Puberty menorrhagia
5.Patients with severe cervical stenosis due to previous history of surgeries on the cervix
6.Unmarried women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To acertain the accuracy and detective ability of intrauterine pathology by saline infusion sono hysterography and vaginal ultrasonography in cases of menorhhagia |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate if saline infusion sonohysterography can be used as an adjuvant to TVS to improve the accuracy of diagnosis of intracavitary pathologies like submucous fibroid ,endometrial polyps ,endometrial hyperplasia & congenital uterine anomalies. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2020 |
| Date of Study Completion (India) |
01/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim:To assess the efficacy of saline hysterography in the evaluation of menorrhagia.2)To evaluate the information derived from vaginal ultrasonography.3)To compare both the modalities to assess which is a more informative procedure. Primary objective : To acertain the accuracy and detective ability of intrauterine pathology by saline infusion sono hysterography and vaginal ultrasonography in cases of menorrhagia . Secondary objective : To evaluate if saline infusion sonohysterography (SIS) can be used as an adjuvant to TVS to improve the accuracy of diagnosis of intracavitatory pathologies like submucous fibroid ,endometrial polyp. |