Soft MarkersNCT03861520
Ultrasonographic Fetal Soft Markers and Aneuploidy
An observational study of Soft Markers, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Soft Markers
- What is being tested?
- Midtrimester anomaly scan and Fetal Karyotyping
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2019to 5 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more
Who may be able to join
- pregnant woman between (16-24) weeks of gestation.
- singelton pregnancy.
Who cannot join
- Multiple pregnancies.
- Mental condition rendering the patients unable to understand the nature and scope of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Soft Markers
- Being tested
- Midtrimester anomaly scan, Fetal Karyotyping
- Keywords
- Anomaly scan, Anuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midtrimester anomaly scanDevice
Also called 2nd trimester anomaly scan
A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy
Fetal KaryotypingGenetic
Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Midtrimester anomaly scan; Genetic: Fetal Karyotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start14 Mar 2019
- Primary completion5 Apr 2020
- Study completion5 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft MarkersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ahmed Bassiouny, Cairo University
- Investigators
- Maha M Mossad, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861520
- Sponsor's protocol ID
- 12019
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy
- ClinicalTrials.gov ID
- NCT03861520
- Acronym / sponsor ID
- 12019
- Conditions
- Soft Markers
- Keywords
- Anomaly scan, Anuploidy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16-24 weeks Pregnant womes | – | Device: Midtrimester anomaly scan, Genetic: Fetal KaryotypingPregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more
Key inclusion criteria (2 listed)
- pregnant woman between (16-24) weeks of gestation.
- singelton pregnancy.
Key exclusion criteria (2 listed)
- Multiple pregnancies.
- Mental condition rendering the patients unable to understand the nature and scope of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midtrimester anomaly scanAlso: 2nd trimester anomaly scanA detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy | Device | 16-24 weeks Pregnant womes |
| Fetal KaryotypingFetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically | Genetic | 16-24 weeks Pregnant womes |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha M Mossad, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Markers, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the association between soft markers identified at second trimester ultrasound and aneuploidy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.