Fetal DopplerNCT05389553
Fetal Doppler and Uterine Artery Blood Volume Correlation.
An observational study of Fetal Doppler and Uterine Blood Flow, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Doppler, Uterine Blood Flow
- What is being tested?
- Ultrasound exam
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2022to 31 Oct 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Full-term pregnancies (37-42 weeks) comprised all pregnant women who would give birth at our hospital.
Who may be able to join
- full-term pregnancies (37-42 weeks)
Who cannot join
- antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
Naples, Italia, 80138
About this study
Official title: The Association Between Fetal Doppler and Uterine Artery Blood Volume at Term of Pregnancy: A Prospective Observational Study.
To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.
Read the detailed description
Introduction: To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.
Materials and Methods: This was a prospective cohort study of 50 nulliparous women booking antenatal care at the University of Campania "Luigi Vanvitelli" between May 2022 and September 2022. All full-term pregnancies accepted for delivery will include. Pregnant women with antepartum haemorrhage, stillbirths, multiple gestations, or congenital abnormalities were excluded. Women underwent a transabdominal ultrasound examination of uterine arteries for measurement of Uterine artery blood volume. Pregnancy outcomes were recorded, and linear regression was used to study the relationship between uterine artery blood volume and fetal Doppler indices. SPSS version 25 (Chicago, IL, USA) was used to code, tabulate, and analyze the data. Quantitative data were analyzed using the student's t-test. Qualitative data were analyzed using the Mann-Whitney test. A statistically significant difference was defined as a p-value of 0.05.
- Conditions
- Fetal Doppler, Uterine Blood Flow
- Being tested
- Ultrasound exam
- Keywords
- Doppler, Pregnancy, ultrasound, uterine blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examOther
We included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth
| Study group | Role | What they receive |
|---|---|---|
| Patients at term of pregnancy | We included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth.
Pregnant women with antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities were excluded. Receives: Other: Ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
We estimate the uterine volume and its correlation with the fetal doppler indices
The volume of the uterine arteries will be measured using a doppler ultrasound. We shall also estimate the fetal doppler indices.
Linear regression will be used to test for a possible relationship between uterus volume blood flow and fetal doppler parameters. Before the delivery, all of these variables will be estimated using an ultrasound exam.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start30 May 2022
- Primary completion30 Jun 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DopplerStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco La Verde, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389553
- Sponsor's protocol ID
- 0010010/i
- Status last verified
- Nov 2023
- First submitted
- 20 May 2022
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Fetal Doppler and Uterine Artery Blood Volume at Term of Pregnancy: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05389553
- Acronym / sponsor ID
- 0010010/i
- Conditions
- Fetal Doppler, Uterine Blood Flow
- Keywords
- Doppler, Pregnancy, ultrasound, uterine blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 25 May 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.
To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.
Detailed description
Introduction: To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.
Materials and Methods: This was a prospective cohort study of 50 nulliparous women booking antenatal care at the University of Campania "Luigi Vanvitelli" between May 2022 and September 2022. All full-term pregnancies accepted for delivery will include. Pregnant women with antepartum haemorrhage, stillbirths, multiple gestations, or congenital abnormalities were excluded. Women underwent a transabdominal ultrasound examination of uterine arteries for measurement of Uterine artery blood volume. Pregnancy outcomes were recorded, and linear regression was used to study the relationship between uterine artery blood volume and fetal Doppler indices. SPSS version 25 (Chicago, IL, USA) was used to code, tabulate, and analyze the data. Quantitative data were analyzed using the student's t-test. Qualitative data were analyzed using the Mann-Whitney test. A statistically significant difference was defined as a p-value of 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at term of pregnancy | – | Other: Ultrasound examWe included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth. Pregnant women with antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities were excluded. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Full-term pregnancies (37-42 weeks) comprised all pregnant women who would give birth at our hospital.
Key inclusion criteria (1 listed)
- full-term pregnancies (37-42 weeks)
Key exclusion criteria (1 listed)
- antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examWe included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth | Other | Patients at term of pregnancy |
Primary outcome
We estimate the uterine volume and its correlation with the fetal doppler indices
Time frame: 1 day
The volume of the uterine arteries will be measured using a doppler ultrasound. We shall also estimate the fetal doppler indices. Linear regression will be used to test for a possible relationship between uterus volume blood flow and fetal doppler parameters. Before the delivery, all of these variables will be estimated using an ultrasound exam.
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 27 Nov 2023.
- 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 Fetal Doppler and Uterine Blood Flow, 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 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: finished, as of the sponsor's last update on 27 Nov 2023. 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?
We estimate the uterine volume and its correlation with the fetal doppler indices (time frame: 1 day). 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 Nov 2023.