Ultrasonographic Fetal Soft Markers and Aneuploidy

Soft Markers Clinical Trial

Official title:

Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861520
• Other study ID #: 12019
• Status: Completed
• Start date: March 14, 2019
• Est. completion date: April 5, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Soft Markers

Intervention

Device:
• Midtrimester anomaly scan
A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy

Genetic:
• Fetal Karyotyping
Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the association between soft markers identified at second trimester ultrasound and aneuploidy.	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