Fetal AnomaliesNCT00943189
Fetal Anomalies Scan at the Time of Nuchal Translucency Study
An observational study of Fetal Anomalies, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Anomalies
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All pregnant women at 12-14 weeks of gestation that are coming for nuchal translucency examination and willing to participate in the study.
Who may be able to join
- pregnant women at 12-14 weeks
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Liat Gindes, MD contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Liat Gindes, MD, gindesl@smile.net.il
About this study
Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.
Read the detailed description
Prospective study of patients at 12-14 weeks gestation that are coming for NT examination is conducted. Meticulous ultrasound examination will be done to the fetuses using trans vaginal and transabdominal techniques. The patients will receive only the NT information. Only in cases of detection of severe fetal anomalies the patient will get the information of the examination and counseling according to the findings. All patients will be asked to provide information of the 15 weeks early comprehensive ultrasound examination. The NT examination will be compared to the 15 weeks ultrasound. All patients will be asked to give information after delivery of the baby's health condition.
- Conditions
- Fetal Anomalies
- Keywords
- Fetal anomalies scan at the time of NT study
- Medical subject headings
- Congenital Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnomaliesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943189
- Sponsor's protocol ID
- SHEBA-08-4934-LG-CTIL
- Status last verified
- Nov 2009
- First submitted
- 21 Jul 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Anomalies Scan at the Time of Nuchal Translucency Study
- ClinicalTrials.gov ID
- NCT00943189
- Acronym / sponsor ID
- SHEBA-08-4934-LG-CTIL
- Conditions
- Fetal Anomalies
- Keywords
- Fetal anomalies scan at the time of NT study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2008
- First posted
- 22 Jul 2009 (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.
Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.
Detailed description
Prospective study of patients at 12-14 weeks gestation that are coming for NT examination is conducted. Meticulous ultrasound examination will be done to the fetuses using trans vaginal and transabdominal techniques. The patients will receive only the NT information. Only in cases of detection of severe fetal anomalies the patient will get the information of the examination and counseling according to the findings. All patients will be asked to provide information of the 15 weeks early comprehensive ultrasound examination. The NT examination will be compared to the 15 weeks ultrasound. All patients will be asked to give information after delivery of the baby's health condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women at 12-14 weeks of gestation that are coming for nuchal translucency examination and willing to participate in the study.
Key inclusion criteria (1 listed)
- pregnant women at 12-14 weeks
Key exclusion criteria (1 listed)
- -
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 20 Nov 2009.
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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.
Liat Gindes, MD contact
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 Fetal Anomalies, run by Sheba Medical Center at 1 site in Israel.
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 1 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 20 Nov 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liat Gindes, MD (gindesl@smile.net.il), or a site near the patient. 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 20 Nov 2009.