Ultrasonographic Fetal Soft Markers and Aneuploidy

April 5, 2020 updated by: Yasmin Ahmed Bassiouny, Cairo University

Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy

The purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. Secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

  • Egypt
      • Cairo, Egypt
        • Cairo University

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more

Description

Inclusion Criteria:

  1. pregnant woman between (16-24) weeks of gestation.
  2. singelton pregnancy.

Exclusion Criteria:

  1. Multiple pregnancies.
  2. Mental condition rendering the patients unable to understand the nature and scope of the study.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
16-24 weeks Pregnant womes
Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more.
Device: Midtrimester anomaly scan
A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy
Other Names:
  • 2nd trimester anomaly scan
Genetic: Fetal Karyotyping
Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study the association between soft markers identified at second trimester ultrasound and aneuploidy.
Time Frame: 1 year

fetal soft markers detection which include the following:

  • choroid plexus cyst.
  • Mild ventriculomegaly.
  • Enlarged cistern magna.
  • Nasal bone hypoplasia.
  • Increased nuchal fold.
  • Echogenic cardiac focus.
  • Single umbilical artery.
  • Pyelectasis.
  • Echogenic bowl.
  • Short femur.
  • Short humerus.

All data will be collected and statistics will be done for the correlation between one or more soft markers with structural anomalies and its relation with aneuploidy.
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Maha M Mossad, MD, Cairo 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 (Actual)

March 14, 2019

Primary Completion (Actual)

April 5, 2020

Study Completion (Actual)

April 5, 2020

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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