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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Bait Balev Hospital
ClinicalTrials.gov Identifier:
NCT02927730
First received: October 6, 2016
Last updated: NA
Last verified: September 2016
History: No changes posted
  Purpose
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

Condition Intervention
Retained Product of Pregnancy
Other: no interventions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Correlation Between Clinical Diagnosis of Retained Placenta And Histology

Resource links provided by NLM:


Further study details as provided by Bait Balev Hospital:

Primary Outcome Measures:
  • the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %. [ Time Frame: sep-oct 2016 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: September 2016
Estimated Study Completion Date: November 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Bait Balev Hospital
ClinicalTrials.gov Identifier: NCT02927730     History of Changes
Other Study ID Numbers: BaitBHresiduaCTIL 
Study First Received: October 6, 2016
Last Updated: October 6, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Bait Balev Hospital:
Retained placenta, surgical hysteroscopy, residua

Additional relevant MeSH terms:
Placenta, Retained
Placenta Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on December 02, 2016