NCT02927730

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 5, 2020

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

October 6, 2016

Last Update Submit

February 2, 2020

Conditions

Retained Product of Pregnancy

Keywords

Retained placenta, surgical hysteroscopy, residua

Outcome Measures

Primary Outcomes (1)

  • the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding is 67.5 %.

    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.

    sep-oct 2016

Study Arms (2)

positive retainted placenta histology

base on chorionic villi in the pathalogic sample

Other: no interventions

negative retainted placenta histology

Other: no interventions

Interventions

no interventionsOTHER

no interventions

negative retainted placenta histologypositive retainted placenta histology

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Women who diagnosed clinically with RPOC
  • women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta, Retained

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

February 5, 2020

Record last verified: 2016-09