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Completed

NCT Number: NCT02927730

The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No interventions

Other

no interventions

Primary outcomes

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

    Time frame: sep-oct 2016

Secondary outcomes

  1. No clinical symptoms increase the accuracy of this diagnosis. There no advantage in the use of diagnostic hysteroscopy in case of suspected retainted placenta.

    Time frame: sep-oct 2016

Sponsors and collaborators

Lead sponsor

Bait Balev Hospital

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Acronym: WHI

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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