The Correlation Between Clinical Diagnosis of Retained Placenta And Histology (WHI)
|ClinicalTrials.gov Identifier: NCT02927730|
Recruitment Status : Active, not recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment|
|Retained Product of Pregnancy||Other: no interventions|
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.
70% correlation between the clinical and pathological diagnosis of RPOC.
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.
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|
|Actual Enrollment :||240 participants|
|Observational Model:||Case Control|
|Official Title:||The Correlation Between Clinical Diagnosis of Retained Placenta And Histology|
|Study Start Date :||September 2016|
|Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||November 2016|
positive retainted placenta histology
base on chorionic villi in the pathalogic sample
Other: no interventions
|negative retainted placenta histology||
Other: no interventions
- the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %. [ Time Frame: sep-oct 2016 ]
- 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 ]