The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

Retained Product of Pregnancy Clinical Trial

— WHI  

Official title:

The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927730
• Other study ID #: BaitBHresiduaCTIL
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Placenta, Retained
• Retained Product of Pregnancy

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