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Clinical Trials/NCT02927730
NCT02927730
Completed
Not Applicable

The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

Bait Balev Hospital0 sites240 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retained Product of Pregnancy
Sponsor
Bait Balev Hospital
Enrollment
240
Primary Endpoint
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. Secondly, to assess different clinical parameters that are likely related to accuracy of the diagnosis of RPOC

Detailed Description

Background: Retained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The reported incidence in the literature is around 1% of all pregnancies. Most often, diagnoses are made on clinical basis and there is only scarce information available related to the correlation between the clinical and pathological diagnosis of RPOC. The gold standard for diagnosis of RPOC is based on histopathological confirmation of chorionic villi in tissue derived from the uterus. Once RPOC is diagnosed on a clinical basis, several treatment options are available, including expectant management, pharmacological treatment, and surgical interventions. Given the risks associated with surgical interventions, accurate diagnosis is vital. Guidelines at Maccabi Health Care Organization mandate that hysteroscopic removal of suspected RPOC should be performed only after approval by a Gynecological Surgical Preauthorization committee. Based on the activity of this committee and starting 2011, Maccabi has developed a database on certain gynecologic-surgical procedures including hysteroscopic removal of suspected RPOC. Purpose of the study: The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. Expected results: 70% correlation between the clinical and pathological diagnosis of RPOC. Methods: Establishing a dedicated database which includes demographic, clinical and histological data of women who have undergone hysteroscopic removal of suspected RPOC and statistical assessment of correlations. Significance: Determination of the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding clinical parameters that may increase the accuracy of this diagnosis and will help to prevent unnecessary procedures.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
October 2017
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bait Balev Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women who diagnosed clinically with RPOC
  • women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC

Exclusion Criteria

  • Women who underwent hysteroscopy presumptive diagnosis of RPOC without documentation of pathological results were excluded.
  • Women who have not performed / recorded sonography test before the hysterocpy.

Outcomes

Primary Outcomes

the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.

Time Frame: sep-oct 2016

Secondary Outcomes

  • No clinical symptoms increase the accuracy of this diagnosis. There no advantage in the use of diagnostic hysteroscopy in case of suspected retainted placenta.(sep-oct 2016)

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