PregnancyNCT05666297
Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition
An observational study of Pregnancy and Ultrasound, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive. For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Ultrasound, Fetal Conditions
- How many people
- 302 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2022to 15 May 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study in question will be conducted prospectively at the structures involved. Participation in the study will be offered to all patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation, foreseen in normal clinical practice.
Who may be able to join
- Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation
Who cannot join
- Less than 18 years old
- Multiple gestations
- Women with an altered state of consciousness, seriously ill, with mental handicaps;
Trial locations and contacts
1 site in 1 country.
Maddalena Morlando, MD,PhD contact
Italy1 site
University of Campania "Luigi Vanvitelli"
Naples, 80138
Maddalena Morlando, MD, +39 333 426 3110, madmorlando@gmail.com
Fabiana Savoia, MD, dott.fabianasavoia@gmail.com
About this study
Official title: Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study
Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive.
For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks).
Read more
Screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. However, the development of three-dimensional (3D) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2D scans. This method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age.
The possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.
- Conditions
- Pregnancy, Ultrasound, Fetal Conditions, Cardiac Abnormalities
- Keywords
- pregnancy, ultrasound, fetal abnormalities, Cardiac Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac abnormalities found in the first trimester of pregnancy
Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan
Measured: Between 11+0 and 13+6 days of pregnancy
Secondary outcomes (3)
Gestational age at delivery
Weeks of gestation at the moment of delivery
Measured: delivery
Preterm birth rates
Measured: Less than 24, 28, 34 weeks gestation
Birth weight
Weight of the baby at the time of delivery
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion15 Feb 2023 (estimated)
- Study completion15 May 2023 (estimated)
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.
- 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
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Schiattarella, University of Campania Luigi Vanvitelli
- Investigators
- Fabiana Savoia, MD, Study chair, University of Campania Luigi VanvitelliAntonio Schiattarella, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666297
- Sponsor's protocol ID
- 37885
- Status last verified
- Dec 2022
- First submitted
- 18 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Cardiac Abnormalities in the First Trimester of Pregnancy by Volumetric Acquisition: an International Multicenter Study
- ClinicalTrials.gov ID
- NCT05666297
- Acronym / sponsor ID
- 37885
- Conditions
- Pregnancy, Ultrasound, Fetal Conditions, Cardiac Abnormalities
- Keywords
- pregnancy, ultrasound, fetal abnormalities, Cardiac Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 27 Dec 2022 (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.
Ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive.
For physiological pregnancy, the Italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks).
Screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. However, the development of three-dimensional (3D) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2D scans. This method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age.
The possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study in question will be conducted prospectively at the structures involved. Participation in the study will be offered to all patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation, foreseen in normal clinical practice.
Key inclusion criteria (1 listed)
- Patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation
Key exclusion criteria (3 listed)
- Less than 18 years old
- Multiple gestations
- Women with an altered state of consciousness, seriously ill, with mental handicaps;
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
Incidence of cardiac abnormalities found in the first trimester of pregnancy
Time frame: Between 11+0 and 13+6 days of pregnancy
Incidence of cardiac abnormalities found in the first trimester of pregnancy by 3D scan
3 secondary outcomes
Gestational age at delivery
Time frame: delivery
Preterm birth rates
Time frame: Less than 24, 28, 34 weeks gestation
Birth weight
Time frame: delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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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.
Maddalena Morlando, MD,PhD contact
Fabiana Savoia, MD study chair
University of Campania Luigi Vanvitelli
Antonio Schiattarella, MD principal investigator
University of Campania Luigi Vanvitelli
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 Pregnancy and Ultrasound, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 3 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 27 Dec 2022. 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 Italy. 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 Antonio Schiattarella, MD (+39 3921653275, antonio.schiattarella@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac abnormalities found in the first trimester of pregnancy (time frame: Between 11+0 and 13+6 days 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 27 Dec 2022.