To study the effect of progesterone hormone containing intra uterine system in women with bleeding diorders
Not Applicable
- Conditions
- Health Condition 1: D680- Von Willebrands disease
- Registration Number
- CTRI/2022/11/047538
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Haematological disorders like coagulation defects and severe anaemia
2. Women on anti coagulant drugs
3. Age more than 18 years
4. Willing to use intrauterine device as a treatment option
5. Willing to participate in study.
Exclusion Criteria
Uterine pathology of abnormal menstrual bleeding
Mullerian anomalies
Wants to conceive
Vaginal or cervical infection
Undiagnosed irregular vaginal bleeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of LNG IUS in reducing menstrual blood flow in women with haematological disorders <br/ ><br>Measure- PBAC scoreTimepoint: At 3 months ,6 months post LNG IUS insertion
- Secondary Outcome Measures
Name Time Method 1.Evaluate improvement in hemoglobin levels after LNG IUS insertion <br/ ><br>2.To evaluate reduction in requirement of anti hemostatic drugs <br/ ><br>3.To evaluate reduction ( if any) in frequency of transfusion of blood products <br/ ><br>4.To evaluate blood flow changes if any, in uterine artery post insertion of LNG IUS <br/ ><br>5.To evaluate improvement in quality of life of women with help of a validated questionnaire.Timepoint: 1,3,6 months post insertion