| CTRI Number |
CTRI/2022/02/040199 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
16/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of hormonal releasing device put in uterus on its blood flow to know how it reduces menstrual bleeding |
|
Scientific Title of Study
|
The effect of levonorgestrel-releasing intrauterine system on uterine blood flow in patients with heavy menstrual bleeding |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avantika Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of Obstetrics & Gynecology All India Institute of Medical Sciences Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
|
| Fax |
|
| Email |
dravantikagupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avantika Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of Obstetrics & Gynecology All India Institute of Medical Sciences Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
|
| Fax |
|
| Email |
dravantikagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avantika Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of Obstetrics & Gynecology All India Institute of Medical Sciences Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
|
| Fax |
|
| Email |
dravantikagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical College, Nagpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Nagpur |
| Address |
All India Institute of Medical Sciences, Mihan, Nagpur |
| 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 Avantika Gupta |
AIIMS Nagpur |
Room no 316
Obstetrics and Gynaecology OPD
Third floor
MIHAN, Nagpur
Maharashtra 441108
Nagpur
MAHARASHTRA |
8903650441
dravantikagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Nagpur instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levonorgestrel intra uterine system insertion |
LNG-IUS will be inserted in the eligible subjects
Baseline PBAC score, uterine artery PI and Ri and endometrial thickness will be noted
This device works for five years. Patients have to follow up for the study at 3 months and 6 months postinsertion |
| Comparator Agent |
Levonorgestrel intrauterine system |
Its a study with comparison of PBAC score, uterine artery blood flow in form PI and RI and endometrial thickness of same subjects at 3rd and 6th months after insertion. this device works for five years |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Any female patient presenting with heavy menstrual bleeding and is not willing for pregnancy for next 2 years will be recruited if PBAC score is >100 and there is no contraindication for putting intrauterine system. |
|
| ExclusionCriteria |
| Details |
Patients with genital infection, hormonal pills in preceding 3 months, coagulopathy, uterine myoma, vascular malformation of uterine artery, genital malignancy will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a) The primary outcome of the study will be measured as uterine artery doppler indices (RI and PI) and endometrial thickness before LNG-IUS insertion and at 3month and 6 month post-insertion |
1) baseline 2) 3 months 3) 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in hemoglobin, complications of LNG-IUS |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an interventional study including women diagnosed with heavy menstrual bleeding (HMB) aged between 20-45 years of age. Total 25 cases will be enrolled for levonorgestrel intrauterine system (LNG-IUS) from outpatients attending the Obstetrics& Gynaecology department, AIIMS Nagpur after fulfilling eligibility criterion from January 2022 to June 2022 after approval from ethics committee. Women will be provided with a printed copy of pictoral blood assessment chart to record the number of days and amount of bleeding postinsertion at 3rd and 6th month follow up. Ultrasound doppler will be done to assess uterine artery impedance in form of pulsatility index (PI) and Resistance index (RI) and endometrial thickness before LNG-IUS insertion, after 3 month of insertion and after 6 months of insertion. LNG-IUS will be provided free of cost to the patients under the study. The women will be provided with a pack of same sized sanitary pads of a particular brand for uniform measurement of blood loss. The primary outcome measures are :-Endometrial thickness, Uterine artery PI and RI and PBAC score Secondary outcomes :- continuation rate, complications and improvement of Hemoglobin |