Validation study of a novel clinical algorithm in evaluating abnormal uterine bleeding using a Combination of Saline Infusion Sonohysterography (SIS) and endometrial brush biopsy (EMB).

Validation study of a novel clinical algorithm in evaluating abnormal uterine bleeding using a Combination of Saline Infusion Sonohysterography (SIS) and endometrial brush biopsy (EMB). - SIS+EMB algorithm validation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41729

Enrollment

200

Registered

2015-03-23

Start date

2016-01-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Abnormal uterine bleeding Postmenopausal uterine bleeding

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Abnormal postmenopausal bleeding with a TED of >4mm. - All women with abnormal postmenopausal bleeding will be informed about the study and asked to agree on participation, in case they do meet the 4mm TED criteria, before sonography is performed.

Exclusion criteria

Exclusion criteria: - TED

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint The main outcome of the research will be the sensitivity, specificity, PPV, NPV of the new algorithm combining SIS & EMB in women with a TED >4mm, compared to hysteroscopy in determining uterine malignancies	—

Secondary

Measure	Time frame
Also the patients* experience (pain, number of visits, economic effects, efficiency etc) will be recorded using a questionnaire.	—

Countries

Netherlands

Outcome results