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).

Completed

• Conditions: Abnormal uterine bleeding; Postmenopausal uterine bleeding; 10038594; 10013326

• Registration Number: NL-OMON41729
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

- TED <=4mm
- Suspected uterine infection
- Suspected intrauterine abnormalities seen on first ultrasound
- Pregnancy
- Pathologic evidence of malignancy
- Being incapacitated

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Also the patients* experience (pain, number of visits, economic effects,<br /><br>efficiency etc) will be recorded using a questionnaire.</p><br>