Diagnostic value of saline infused sonography compared to hysteroscopy in detecting retained products of conception.
- Conditions
- Retained products of conception
- Registration Number
- NL-OMON29567
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 186
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
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Comparison of the diagnostic methods (TVUS, SIS and hysteroscopy) in terms of:<br>o VAS-score<br>o Patient satisfaction<br>o Complications<br><br>- Characteristics of the hysteroscopic treatment of RPOC:<br>o Method of removal<br>o Complexity of removal, determined by the operator as: low, medium, high<br>o Operating time<br>o Peri- and postoperative complications (e.g. excessive fluid deficit, perforation, hemorrhage, postoperative infection)<br>o Availability of tissue for pathological analysis and pathology results<br>o Completeness of removal and presence of intrauterine adhesions at second look hysteroscopy<br>o Persistence of symptoms<br>o Necessity for additional treatment<br>o Relationship between these characteristics and the Gutenberg classification<br><br>- Interobserver variability of the diagnostic procedures