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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927730
Other study ID # BaitBHresiduaCTIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date October 2017

Study information

Verified date September 2016
Source Bait Balev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date October 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 42 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
no interventions
no interventions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Bait Balev Hospital Maccabi Healthcare Services, Israel

Outcome

Type Measure Description Time frame Safety issue
Primary the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %. sep-oct 2016
Secondary 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