RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the Saline Infusion Sonography (SIS) in postmenopausal women
Completed
- Conditions
- Postmenopausal bleeding and a thickened endometrium
- Registration Number
- NL-OMON22688
- Lead Sponsor
- Máxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 232
Inclusion Criteria
Women with postmenopausal bleeding and an endometrial thickness of 4mm or more.
Exclusion Criteria
Women receiving Hormone Replacement Therapy.
Women receiving Tamoxifen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint is to investigate the quality of the endometrial samples obtained before or after SIS to determine whether the order of investigations is of any influence to the percentages of sufficient endometrial samples (assessable).<br>
- Secondary Outcome Measures
Name Time Method Secondary outcomes are to determine whether the order of investigations is of any influence to the reliability of the SIS images and to determine which investigation is experienced as the most painful. Furthermore we will evaluate the failed procedures and specific pathological analysis will be performed by a pathologist specialized in gynaeco-pathology. <br>