Ultrasound Satisfaction in Pregnant Women1/2024NCT06441929
Pregnancy Ultrasound Satisfaction Scoring System
An observational study of Ultrasound Satisfaction in Pregnant Women, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Satisfaction in Pregnant Women
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 28 Mar 2024
- 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: A cohort of pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation
Who may be able to join
- Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.
Who cannot join
- No limiting factors described above
- No pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System
Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.
Read the detailed description
This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.
The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator ultrasound satisfaction
Operator ultrasound satisfaction, rating as "low", "good", or "very good"
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Satisfaction in Pregnant WomenStudies 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
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Zupo, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441929
- Sponsor's protocol ID
- 1/2024
- Acronym
- 1/2024
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System
- ClinicalTrials.gov ID
- NCT06441929
- Acronym / sponsor ID
- 1/2024 / 1/2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 4 Jun 2024 (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.
Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.
Detailed description
This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.
The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation
Key inclusion criteria (1 listed)
- Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.
Key exclusion criteria (2 listed)
- No limiting factors described above
- No pregnant women
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
Operator ultrasound satisfaction
Time frame: baseline
Operator ultrasound satisfaction, rating as "low", "good", or "very good"
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 4 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound Satisfaction in Pregnant Women, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 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 4 Jun 2024. 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?
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?
Operator ultrasound satisfaction (time frame: baseline). 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 4 Jun 2024.