Fetal Growth Restriction (FGR)ARDEFNCT06717555
Observational Study on Fetal Growth Restriction Complicated by Early Flowmetric Alterations
An observational study of Fetal Growth Restriction (FGR), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to to understand whether the presence of flowmetric alterations in association with early growth retardation (i.e., before 22 weeks gestational age) is associated with worse neonatal and maternal outcomes than intrauterine growth retardation arising later in life. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Fetal Growth Restriction (FGR)
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 31 Dec 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 44 years
- Women only
- Adult
Study population: The study group will consist of patients with single pregnancies complicated by intrauterine growth restriction, who access the Pregnancy at Risk Outpatient Clinic, of the Division of Obstetrics and Prenatal Medicine of Policlinico Sant'Orsola to perform the specific diagnostic-care pathway.
Who may be able to join
- Age > 18 years
- Single pregnancy
- Ultrasound monitoring and delivery at Policlinico S. Orsola in Bologna, Italy
- Acquisition of informed consent form
Who cannot join
- Desire to perform Voluntary Interruption of Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Fetal Growth Restriction Complicated by Early Flowmetric Alterations. ARDEF Adverse or Reverse End Diastolic Flow
The goal of this observational study is to to understand whether the presence of flowmetric alterations in association with early growth retardation (i.e., before 22 weeks gestational age) is associated with worse neonatal and maternal outcomes than intrauterine growth retardation arising later in life.
Read the detailed description
The study is prospective and retrospective. As far as concerns the retrospective part, patients for whom pregnancy was monitored at the outpatient clinics of the division of Obstetrics and Prenatal Age Medicine will be enrolled. This is necessary to obtain specific information about the complication rate and progression of pregnancies complicated by fetal growth restriction over the past 15 years (2005 to present) followed at our hospital.
In association with this retrospective part, a prospective part of the study will be conducted: all patients will undergo the ultrasound evaluations required by the normal care protocols for pregnancies complicated by growth restriction (controls 2 times a week or three times a week).
In addition to standard ultrasound monitoring, an instrumental assessment will then be performed using the USCOM 1A ® technique, an ultrasound instrument that, by entering the patient's height and weight, is able to calculate, by means of internal algorithms, the diameter of the aortic valve and blood flow through the valve. In addition, the peak pulsatility of the maternal ophthalmic artery, using Doppler ultrasound technique, which appears to be predictive of the risk of developing preeclampsia, will be evaluated.
An echocardiographic acquisition of the fetal heart using STRAIN technique will then be performed in the context of normal ultrasound. Two-dimensional strain is based on the acquisition of a typical myocardial pattern (called finger print), which can be followed during the cardiac cycle. In other words, the software recognizes a small piece of tissue, evaluating its strain. Because of its angle-independence, two-dimensional strain allows global and segmental assessment of myocardial contractility, both longitudinal and radial. In these patients, strain would have the ability to detect a contractility deficit evidenced by a reduction in peak systolic strain and strain rate that, as already demonstrated in the adult, distinguishes areas of increased fibrosis, myocyte loss, and myocardial fiber reorganization (as in the case of disarray). Strain may also be useful in prognostic stratification of heart failure by distinguishing fetuses with particularly impaired contractile capacity. These two additional instrumental assessments, will require no more than 4 minutes more for the complete examination.
Patients will be adequately informed about the purpose and modalities of the study, and informed consent form will be acquired. Patients will be managed according to company protocols.
- Conditions
- Fetal Growth Restriction (FGR)
- Keywords
- flowmetric alterations, FGR
- Medical subject headings
- Fetal Growth Retardation
What is being measured
The primary outcome is the main question the study is designed to answer.
Collecting outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations
To collect the outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations, at prenatal ultrasound, to obtain information useful for counseling these patients (for patients in the retrospective part, from 2005 to the present).
To analyze the presence of any correlations between different outcomes in this subpopulation of patients with hemodynamic changes (in terms of central and peripheral resistances) of patients and fetuses in pregnancies complicated by placental insufficiency and fetal growth restriction (for patients in the prospective part up to December 2026).
Measured: During prenatal ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start15 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth Restriction (FGR)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuliana Simonazzi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717555
- Sponsor's protocol ID
- ARDEF
- Acronym
- ARDEF
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Fetal Growth Restriction Complicated by Early Flowmetric Alterations. ARDEF Adverse or Reverse End Diastolic Flow
- ClinicalTrials.gov ID
- NCT06717555
- Acronym / sponsor ID
- ARDEF / ARDEF
- Conditions
- Fetal Growth Restriction (FGR)
- Keywords
- flowmetric alterations, FGR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Dec 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.
The goal of this observational study is to to understand whether the presence of flowmetric alterations in association with early growth retardation (i.e., before 22 weeks gestational age) is associated with worse neonatal and maternal outcomes than intrauterine growth retardation arising later in life.
Detailed description
The study is prospective and retrospective. As far as concerns the retrospective part, patients for whom pregnancy was monitored at the outpatient clinics of the division of Obstetrics and Prenatal Age Medicine will be enrolled. This is necessary to obtain specific information about the complication rate and progression of pregnancies complicated by fetal growth restriction over the past 15 years (2005 to present) followed at our hospital.
In association with this retrospective part, a prospective part of the study will be conducted: all patients will undergo the ultrasound evaluations required by the normal care protocols for pregnancies complicated by growth restriction (controls 2 times a week or three times a week).
In addition to standard ultrasound monitoring, an instrumental assessment will then be performed using the USCOM 1A ® technique, an ultrasound instrument that, by entering the patient's height and weight, is able to calculate, by means of internal algorithms, the diameter of the aortic valve and blood flow through the valve. In addition, the peak pulsatility of the maternal ophthalmic artery, using Doppler ultrasound technique, which appears to be predictive of the risk of developing preeclampsia, will be evaluated.
An echocardiographic acquisition of the fetal heart using STRAIN technique will then be performed in the context of normal ultrasound. Two-dimensional strain is based on the acquisition of a typical myocardial pattern (called finger print), which can be followed during the cardiac cycle. In other words, the software recognizes a small piece of tissue, evaluating its strain. Because of its angle-independence, two-dimensional strain allows global and segmental assessment of myocardial contractility, both longitudinal and radial. In these patients, strain would have the ability to detect a contractility deficit evidenced by a reduction in peak systolic strain and strain rate that, as already demonstrated in the adult, distinguishes areas of increased fibrosis, myocyte loss, and myocardial fiber reorganization (as in the case of disarray). Strain may also be useful in prognostic stratification of heart failure by distinguishing fetuses with particularly impaired contractile capacity. These two additional instrumental assessments, will require no more than 4 minutes more for the complete examination.
Patients will be adequately informed about the purpose and modalities of the study, and informed consent form will be acquired. Patients will be managed according to company protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study group will consist of patients with single pregnancies complicated by intrauterine growth restriction, who access the Pregnancy at Risk Outpatient Clinic, of the Division of Obstetrics and Prenatal Medicine of Policlinico Sant'Orsola to perform the specific diagnostic-care pathway.
Key inclusion criteria (4 listed)
- Age > 18 years
- Single pregnancy
- Ultrasound monitoring and delivery at Policlinico S. Orsola in Bologna, Italy
- Acquisition of informed consent form
Key exclusion criteria (1 listed)
- Desire to perform Voluntary Interruption of Pregnancy
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
Collecting outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations
Time frame: During prenatal ultrasound
To collect the outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations, at prenatal ultrasound, to obtain information useful for counseling these patients (for patients in the retrospective part, from 2005 to the present). To analyze the presence of any correlations between different outcomes in this subpopulation of patients with hemodynamic changes (in terms of central and peripheral resistances) of patients and fetuses in pregnancies complicated by placental insufficiency and fetal growth restriction (for patients in the prospective part up to December 2026).
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 5 Dec 2024.
Related trials for Fetal Growth Restriction (FGR)
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingObservational study
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
GDM, Preterm Preeclampsia
RecruitingObservational study
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Fetal Growth Restriction (FGR), Preterm Birth
RecruitingObservational study
DIFFUSION WEIGHTED MRI FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION
Fetal Growth Restriction (FGR)
RecruitingObservational study
Placental Biology in Health and Disease
Pre-eclampsia, Gestational Diabetes Mellitus (GDM)
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.
Giuliana Simonazzi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Growth Restriction (FGR), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 4 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 5 Dec 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?
Collecting outcomes of pregnancies complicated by growth restriction and early-onset flowmetric alterations (time frame: During prenatal ultrasound). 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 5 Dec 2024.