Retained products of conception
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Catharina ziekenhuis Eindhoven