Retained Product of PregnancyWHINCT02927730
The Correlation Between Clinical Diagnosis of Retained Placenta And Histology
An observational study of Retained Product of Pregnancy, run by Bait Balev Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Retained Product of Pregnancy
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Women who diagnosed clinically with RPOC
- women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC
Who cannot join
- 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.
About this study
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
Read the 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.
- Conditions
- Retained Product of Pregnancy
- Being tested
- no interventions
- Keywords
- Retained placenta, surgical hysteroscopy, residua
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no interventions
| Study group | Role | What they receive |
|---|---|---|
| positive retainted placenta histology | base on chorionic villi in the pathalogic sample Receives: Other: no interventions | |
| negative retainted placenta histology | Not described Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.
Measured: sep-oct 2016
Secondary outcomes (1)
No clinical symptoms increase the accuracy of this diagnosis. There no advantage in the use of diagnostic hysteroscopy in case of suspected retainted placenta.
Measured: sep-oct 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Product of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bait Balev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927730
- Sponsor's protocol ID
- BaitBHresiduaCTIL
- Acronym
- WHI
- Status last verified
- Sep 2016
- First submitted
- 6 Oct 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Clinical Diagnosis of Retained Placenta And Histology
- ClinicalTrials.gov ID
- NCT02927730
- Acronym / sponsor ID
- WHI / BaitBHresiduaCTIL
- Conditions
- Retained Product of Pregnancy
- Keywords
- Retained placenta, surgical hysteroscopy, residua
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Bait Balev HospitalUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive retainted placenta histology | – | Other: no interventionsbase on chorionic villi in the pathalogic sample |
| negative retainted placenta histology | – | Other: no interventions |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women who diagnosed clinically with RPOC
- women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionsno interventions | Other | negative retainted placenta histology, positive retainted placenta histology |
Primary outcome
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.
Time frame: sep-oct 2016
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Retained Product of Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Recruiting
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Product of Pregnancy, run by Bait Balev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %. (time frame: sep-oct 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.