Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?

February 15, 2016 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage

Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded.

Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome

Study Type

Observational

Enrollment (Anticipated)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients visiting The Obstetrics department in Ain Shams University Hospital complaining of early second trimesteric abortion

Description

Inclusion Criteria:

  • Pregnancy duration: early mid-trimester from 14 to 20 weeks
  • Endometrial mass upon ultrasound examination after second trimesteric miscarriage

Exclusion Criteria:

  • Uterine congenital anomaly
  • Patients with signs of sepsis.
  • Negative scan after second trimesteric miscarriage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage
Time Frame: 60 minutes after delivery
All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage
60 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USDIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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