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Evaluation of the use of Mirena IUD in patients with increased uterine bleeding with blood clotting disorders.

Evaluation of the use of the Levonorgestrel-releasing Intrauterine Device to control Abnormal Uterine Bleeding in patients with hereditary coagulopathy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5vyd2x
Enrollment
Unknown
Registered
2020-02-03
Start date
2017-03-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Von Willebrand's disease

Interventions

20 participants diagnosed with IHD and AUB were enrolled in a prospective clinical study to compare volume of menstrual bleeding and quality of life before and after LNG-IUD placement. We used a picto
Device

Sponsors

Faculdade de Medicina-Universidade Federal de Minas Gerais
Lead Sponsor
Faculdade de Medicina-Universidade Federal de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Participants were women previously diagnosed with inherited coagulopathies presenting excessive menstrual bleeding

Exclusion criteria

Exclusion criteria: Myomatosis; use of anticoagulants; uterine malformations; contraindications to the use of levonorgestrel device

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: To evaluate the efficiency of LNG-IUD use in controlling increased menstrual bleeding in patients with DHH verified by pictogram, amenorrhea rate, serum iron and ferritin levels, improvement of quality of life. ;Outcome found 1: We found that LNG-IUD proved to be a safe and effective method for use in patients with DHH, with satisfactory results in reducing bleeding and improving quality of life.;Expected outcome 2: To evaluate the reduction in uterine bleeding volume using the pictogram, comparing the bleeding volume of these patients before and 3 and 6 months after device insertion.;Outcome found 2: After 6 months, there was a significant reduction in menstrual bleeding volume, with a reduction in the average pictogram score from 407.0 to 8.3 (p menor que 0.001).;Expected outcome 3: To evaluate the proportion of these patients who progressed to amenorrhea through medical interview and physical examination at 3 and 6 months after the intervention.;Outcome found 3: After 6 months, there was a significant reduction in menstrual bleeding volume, with a reduction in the average pictogram score from 407.0 to 8.3 (p menor que 0.001) with amenorrhea in 75% of cases.;Expected outcome 4: To assess whether reduction in uterine bleeding altered serum hemoglobin, serum iron and serum ferritin levels before and 6 months after insertion of the LNG-IUD. This outcome was assessed by serum hemoglobin, iron and ferritin levels before the intervention and at 3 months and 6 months after the intervention.;Outcome found 4: There was no statistical difference in serum hemoglobin and ferritin values, but there was a significant increase in serum iron values (mean 73.7 pretreatment and 101.3 after 6 months; p igual a 0.003).;Expected outcome 5: Evaluate the improvement of patients' quality of life after device insertion by applying the SF-36 questionnaire, which was applied before insertion and 6 months after.;Outcome found 5: Regarding the assessment of qualit

Secondary

MeasureTime frame
No Secondary Outcomes Expected

Countries

Brazil

Contacts

Public ContactAna Lunardi

Faculdade de Medicina-Universidade Federal de Minas Gerais

ana_lunardi@yahoo.com.br553133094697

Outcome results

None listed

Source: REBEC (via WHO ICTRP)