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To study the effect of progesterone hormone containing intra uterine system in women with bleeding diorders

Efficacy of levonorgestrel intrauterine system in reducing menstrual blood loss in women with haematological disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047538
Enrollment
35
Registered
2022-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D680- Von Willebrands disease

Interventions

Intervention1: LNG IUS: Patient will be councelled and explained the procedure. Risk banefit of LNG IUS will be told.Patient asked to lie down in lithotomy position and a bimanualexamination will be d

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Uterine pathology of abnormal menstrual bleeding Mullerian anomalies Wants to conceive Vaginal or cervical infection Undiagnosed irregular vaginal bleeding

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of LNG IUS in reducing menstrual blood flow in women with haematological disorders Measure- PBAC scoreTimepoint: At 3 months ,6 months post LNG IUS insertion

Secondary

MeasureTime frame
1.Evaluate improvement in hemoglobin levels after LNG IUS insertion 2.To evaluate reduction in requirement of anti hemostatic drugs 3.To evaluate reduction ( if any) in frequency of transfusion of blood products 4.To evaluate blood flow changes if any, in uterine artery post insertion of LNG IUS 5.To evaluate improvement in quality of life of women with help of a validated questionnaire.Timepoint: 1,3,6 months post insertion

Countries

India

Contacts

Public ContactJai Shree

AIIMS New Delhi

garimakachhawa2012@gmail.com9868246702

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026