The Correlation Between Clinical Diagnosis of Retained Placenta And Histology (WHI)

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

Study Overview

• Status: Completed
• Conditions: Retained Product of Pregnancy
• Intervention / Treatment: Other: no interventions

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.

• Study Type: Observational
• Enrollment (Actual): 240

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Study population consists of women who were diagnosed clinically with the rest of the placenta after birth or termination of pregnancy (miscarriage or artificial). The women passed the approval of the Commission and undergo therapeutic hysteroscopy. The information is taken from a database of relevant actions Maccabi Healthcare Services, and includes data from 2012 to 2015.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
positive retainted placenta histology; base on chorionic villi in the pathalogic sample	Other: no interventions; no interventions
negative retainted placenta histology	Other: no interventions; no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.	sep-oct 2016

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bait Balev Hospital
• Collaborators: Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Retained placenta, surgical hysteroscopy, residua
• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases; Placenta, Retained
• Other Study ID Numbers: BaitBHresiduaCTIL