PregnancyNCT01404221
Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications
An observational study of Pregnancy and Fetal Aneuploidy, run by Northwell Health.
Trial summary
Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications? Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Fetal Aneuploidy
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2015
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks
Who may be able to join
- Pregnant women at approximately 20 weeks
- ages 18-50
- singleton pregnancy
- plans to deliver at North Shore University Hosp
- completed step-wise sequential screening
Who cannot join
- multifetal gestation
- minors
- patients who have undergone diagnostic genetic testing
- incarcerated patients
- intention to deliver at a hospital other than North Shore University hosp
About this study
Official title: The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications
Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?
Read the detailed description
Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.
- Conditions
- Pregnancy, Fetal Aneuploidy
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
In patients who have undergone step-wise sequential screening, how often will the evaluation of 10 midtrimester sonographic soft markers of aneuploidy such that the recommendation regarding invasive diagnostic testing be changed?
Measured: completion of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startMar 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: No safety issues. Need to rewrite protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burt Rochelson, Northwell Health
- Investigators
- Burton Rochelson, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404221
- Sponsor's protocol ID
- IRB 07-077
- Status last verified
- Apr 2015
- First submitted
- 26 Jul 2011
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications
- ClinicalTrials.gov ID
- NCT01404221
- Acronym / sponsor ID
- IRB 07-077
- Conditions
- Pregnancy, Fetal Aneuploidy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No safety issues. Need to rewrite protocol
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Jul 2011 (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.
Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?
Detailed description
Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks
Key inclusion criteria (5 listed)
- Pregnant women at approximately 20 weeks
- ages 18-50
- singleton pregnancy
- plans to deliver at North Shore University Hosp
- completed step-wise sequential screening
Key exclusion criteria (5 listed)
- multifetal gestation
- minors
- patients who have undergone diagnostic genetic testing
- incarcerated patients
- intention to deliver at a hospital other than North Shore University hosp
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
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
Time frame: completion of pregnancy
In patients who have undergone step-wise sequential screening, how often will the evaluation of 10 midtrimester sonographic soft markers of aneuploidy such that the recommendation regarding invasive diagnostic testing be changed?
Results and safety
The study was stopped early (reason given: No safety issues. Need to rewrite protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Burton Rochelson, MD principal investigator
Northwell Health
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Fetal Aneuploidy, run by Northwell Health.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Apr 2015. 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?
The study was stopped early (reason given: No safety issues. Need to rewrite protocol). 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.
What does the primary outcome measure?
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers (time frame: completion of pregnancy). 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 14 Apr 2015.