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

Endometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22688

Enrollment

232

Registered

2016-02-16

Start date

2016-04-11

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Postmenopausal bleeding and a thickened endometrium

Interventions

We will perform a randomised controlled trial comparing two diagnostic work-ups. One group will first receive SIS and subsequent office endometrial sampling, and the other group will first receive off

Eligibility

Inclusion criteria

Inclusion criteria: Women with postmenopausal bleeding and an endometrial thickness of 4mm or more.

Exclusion criteria

Exclusion criteria: Women receiving Hormone Replacement Therapy. Women receiving Tamoxifen Women with cervical cancer.

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactAlbertine Vroom

Máxima Medisch Centrum

a.vroom@student.maastrichtuniversity.nl+31612339503

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)