Clinical Trial: The Correlation Between Clinical Diagnosis of Retained Placenta And Histology
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: The Correlation Between Clinical Diagnosis of Retained Placenta And Histology
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 Summary:
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 st
Sponsor: Bait Balev Hospital
Current Primary Outcome: the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %. [ Time Frame: sep-oct 2016 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Bait Balev Hospital
Dates:
Date Received: October 6, 2016
Date Started: September 2016
Date Completion: November 2016
Last Updated: October 6, 2016
Last Verified: September 2016
