Ultrasonographic Fetal Soft Markers and Aneuploidy

NCT ID: NCT03861520

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-14

Study Completion Date

2020-04-05

Brief Summary

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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

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Conditions

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Soft Markers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Midtrimester anomaly scan

Intervention Type DEVICE

A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy

Fetal Karyotyping

Intervention Type GENETIC

Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically

Interventions

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Midtrimester anomaly scan

A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy

Intervention Type DEVICE

Fetal Karyotyping

Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically

Intervention Type GENETIC

Other Intervention Names

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2nd trimester anomaly scan

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Ahmed Bassiouny

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha M Mossad, MD

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12019

Identifier Type: -

Identifier Source: org_study_id

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