The main objective is to compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of SIS with hysteroscopy for the diagnosis of RPOC. Secondary objectives are the complications related to the diagnostic…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity, positive and negative predictive value of SIS
compared to diagnostic hysteroscopy for the diagnosis of RPOC.
Secondary outcome
- Comparison of the diagnostic methods (TVUS, SIS and hysteroscopy) in terms of
VAS-score; patient satisfaction, complications
- Characteristics of the hysteroscopic treatment of RPOC
- Interobserver variability of the diagnostic tests
Background summary
Retained products of conception (RPOC) can occur following miscarriage,
termination of pregnancy (TOP) or delivery with a prevalence of 1%. Symptoms
are vaginal bleeding, uterine tenderness, pelvic pain and fever. Treatment
consists of curettage or hysteroscopic removal. The gold standard for the
diagnosis of RPOC is hysteroscopy. A less invasive method is transvaginal
ultrasound (TVUS), however, the sensitivity and specificity of this diagnostic
test are lower and vary among studies (respectively 44-93% and 74-92%). Data
suggest that the test characteristics of saline infused sonography (SIS) might
be higher. SIS is often used to diagnose polyps and myomas. Studies have
demonstrated that this method is less painful than hysteroscopy. For the
diagnosis of polyps and myomas, SIS also provides better test characteristics
compared to TVUS. For these reasons, we want to compare the test
characteristics of TVUS, SIS and hysteroscopy for diagnosing RPOC.
Study objective
The main objective is to compare the test characteristics (sensitivity,
specificity, positive and negative predictive value) of SIS with hysteroscopy
for the diagnosis of RPOC. Secondary objectives are the complications related
to the diagnostic methods, the characteristics of hysteroscopic removal of RPOC
and the interobserver variability of the diagnostic tests.
Study design
Prospective diagnostic study
Study burden and risks
TVUS is currently the most widely performed diagnostic test for RPOC but has
poor test characteristics. Data suggest that the test characteristics of SIS
might be higher. SIS is often performed at a gynaecological unit, e.g. in
diagnosing polyps and myomas.
One of the benefits is definitive diagnosis of RPOC by diagnostic hysteroscopy,
which can help to avoid unnecessary treatment.
Risks for patients are considered low and include complications related to SIS
(postprocedural fever 0.78% bleeding) and related to diagnostic hysteroscopy
(perforation 0,13%, infection 0,06%, bleeding).
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Ultrasound suggestive of RPOC
Exclusion criteria
Patients presenting with fever or heavy menstrual bleeding in need of immediate
surgical treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76577.100.21 |
| Other | NL9297 |