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Diagnostic value of saline infused sonography compared to hysteroscopy in detecting retained products of conception.

Diagnostic value of saline infused sonography compared to hysteroscopy in detecting retained products of conception.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29567
Enrollment
186
Registered
2021-02-17
Start date
2021-04-01
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

Retained products of conception

Interventions

A saline infusion sonography will be performed

Sponsors

Catharina Ziekenhuis Eindhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 18 years - Ultrasound suggestive of RPOC - Willing to give informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients presenting with fever or heavy menstrual bleeding in need of immediate surgical treatment. Patients with negative findings at ambulant diagnostic hysteroscopy will not be treated with operative hysteroscopy as treatment is then no longer necessary. Data on this matter will be collected. Only patients with confirmation of RPOC by ambulant diagnostic hysteroscopy at a minimum of 5 weeks after the end of pregnancy will be treated.

Design outcomes

Primary

MeasureTime frame
The aim of this study is to compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of SIS with hysteroscopy for the diagnosis of RPOC.

Secondary

MeasureTime frame
- Comparison of the diagnostic methods (TVUS, SIS and hysteroscopy) in terms of: o VAS-score o Patient satisfaction o Complications - Characteristics of the hysteroscopic treatment of RPOC: o Method of removal o Complexity of removal, determined by the operator as: low, medium, high o Operating time o Peri- and postoperative complications (e.g. excessive fluid deficit, perforation, hemorrhage, postoperative infection) o Availability of tissue for pathological analysis and pathology results o Completeness of removal and presence of intrauterine adhesions at second look hysteroscopy o Persistence of symptoms o Necessity for additional treatment o Relationship between these characteristics and the Gutenberg classification - Interobserver variability of the diagnostic procedures

Contacts

Public ContactLaura D'hoore

Catharina ziekenhuis Eindhoven

laura.dhoore@ugent.be040 - 239 93 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)