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Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.

Effectiveness of saline-infused sonography and hysteroscopy in the work-up for postmenopausal bleeding.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24422
Enrollment
200
Registered
2009-12-03
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Endometrial polyps, Postmenopausal bleeding. In Dutch: Endometrium Poliepen, Postmenopauzaal bloedverlies.

Interventions

Eligible patients will be randomly allocated to undergo saline infused sonography (SIS) and outpatient hysteroscopy. All patients will undergo SIS and hysteroscopy independent of the findings during S

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with postmenopausal bleeding and an endometrial thickness of more than 4 mm in whom a malignancy is ruled out by office endometrial sampling.

Exclusion criteria

Exclusion criteria: 1. Women with postmenopausal bleeding during tamoxifen or arimidex treatment; 2. Women with an endometrial sample containing insufficient material for a reliable diagnosis; 3. Women with suspected malignancy after endometrial sampling or cervical cytology.

Design outcomes

Primary

MeasureTime frame
The recurrence of postmenopausal bleeding.

Secondary

MeasureTime frame
Secondary outcomes are: 1. What is the added informativeness of SIS in the diagnosis of endometrial polyps using hysteroscopy as a reference standard? 2. What are the costs of transvaginal sonography, SIS and hysteroscopy as well as the costs of recurrent postmenopausal bleeding?

Contacts

Public ContactM.C. Breijer

Meibergdreef 9

m.c.breijer@amc.uva.nl+31 (0)6 41269280

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)