Ultrasonographic Fetal Soft Markers and Aneuploidy

Completed

• Conditions: Soft Markers
• Interventions: Device: Midtrimester anomaly scan; Genetic: Fetal Karyotyping

• Registration Number: NCT03861520
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-03-14
• Status Verified: 2020-04
• Primary Completion: 2020-04-05
• Study Completion: 2020-04-05
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
16-24 weeks Pregnant womes	Midtrimester anomaly scan	Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more.
16-24 weeks Pregnant womes	Fetal Karyotyping	Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more.

Primary Outcome Measures

Name	Time	Method
To study the association between soft markers identified at second trimester ultrasound and aneuploidy.	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt