The effect of hormonal releasing device put in uterus on its blood flow to know how it reduces menstrual bleeding

Not yet recruiting

• Conditions: Excessive and frequent menstruation with regular cycle,

• Registration Number: CTRI/2022/02/040199
• Lead Sponsor: All India Institute of Medical Sciences Nagpur

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-03
• Last Update Posted: 2022-01-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

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.

Exclusion Criteria

Patients with genital infection, hormonal pills in preceding 3 months, coagulopathy, uterine myoma, vascular malformation of uterine artery, genital malignancy will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
improvement in hemoglobin, complications of LNG-IUS	3 and 6 months

Trial Locations

Locations (1)

AIIMS Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

AIIMS Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Avantika Gupta

Principal investigator

8903650441

dravantikagupta@gmail.com