Orbital VolumeNCT01594944
Fetal Orbital Measurements by 3D Ultrasound
An observational study of Orbital Volume, run by Meir Medical Center.
Trial summary
The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Orbital Volume
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2012to not given
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women 13-37w
Who may be able to join
- well dated singleton pregnancies
Who cannot join
- multiple pregnancy
- pregnancies with known malformations,
- chromosomal abnormalities or
- intrauterine infections
About this study
The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. The investigators will examine 5-10 women in each gestational age in order to create a normal values curve throughout pregnancy.
- Conditions
- Orbital Volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital VolumeStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594944
- Sponsor's protocol ID
- MMC110046CTIL
- Status last verified
- May 2012
- First submitted
- 7 May 2012
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Orbital Measurements by 3D Ultrasound
- ClinicalTrials.gov ID
- NCT01594944
- Acronym / sponsor ID
- MMC110046CTIL
- Conditions
- Orbital Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2012
- First posted
- 9 May 2012 (estimated)
- 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 investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. The investigators will examine 5-10 women in each gestational age in order to create a normal values curve throughout pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women 13-37w
Key inclusion criteria (1 listed)
- well dated singleton pregnancies
Key exclusion criteria (4 listed)
- multiple pregnancy
- pregnancies with known malformations,
- chromosomal abnormalities or
- intrauterine infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Volume, run by Meir Medical Center.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 9 May 2012.