The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

NCT ID: NCT02927730

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-31

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.

Conditions

Retained Product of Pregnancy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

positive retainted placenta histology

base on chorionic villi in the pathalogic sample

no interventions

Intervention Type: OTHER

no interventions

negative retainted placenta histology

no interventions

Intervention Type: OTHER

no interventions

Interventions

no interventions

no interventions

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Bait Balev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BaitBHresiduaCTIL

Identifier Type: -

Identifier Source: org_study_id