Intrauterine Fetal DeathNCT06825481
Uterine Doppler As StillbirthPredictor
An observational study of Intrauterine Fetal Death, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to define the predictive value of intrauterine fetal death for different longitudinal patterns of uterine artery Doppler indices (UtA-PI, UtA-RI and notch) from the second and third trimester of pregnancy in patients admitted with a diagnosis of intrauterine foetal death in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Fetal Death
- How many people
- 4,863 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 1 Mar 2026
- 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
- No healthy volunteers
- Adult
Study population: Assuming a standard deviation of 0.5 in the Doppler values of both cases and controls and a difference in the intercepts of 30% of the two regression lines, it is estimated that 72 cases and 4791 controls are needed to obtain a power of 80% at a type I error of 5%. The controls will be represented by the Doppler values reported in the literature for pregnancies not complicated by MEF.
Who may be able to join
- Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks
- Obtaining informed consent form
Who cannot join
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Antonio Farina, MD, +390512143110, antonio.farina@unibo.it
About this study
The goal of this observational study is to define the predictive value of intrauterine fetal death for different longitudinal patterns of uterine artery Doppler indices (UtA-PI, UtA-RI and notch) from the second and third trimester of pregnancy in patients admitted with a diagnosis of intrauterine foetal death in the period January 2010-April 2020.
Read the detailed description
No changes in the obstetrical conduct of patients with MEFs are expected, since the data will be analysed retrospectively in patients in whom the event of intrauterine foetal death has already occurred. Patients will be treated according to normal clinical protocols.
The following information will be recorded for each patient
- Age
- Body mass index (BMI)
- Ethnicity
- Parity
- Method of pregnancy onset (spontaneous vs. medically assisted procreation)
- Maternal pathologies (if any)
- Any foetal pathologies
- Ultrasound parameters in the second and third trimester of pregnancy
- Estimation of fetal weight
- Umbilical artery Doppler (UA-PI)
- Uterine artery Doppler (UtA-PI, UtA-RI and notch)
- Gestational age of fetal endouterine death
- Type of delivery
- Newborn and placental weight
- Histopathological findings of newborn and annexes (placenta and umbilical cord)
- Conditions
- Intrauterine Fetal Death
- Keywords
- Uterine Doppler
- Medical subject headings
- Stillbirth
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF
Data will be analyzed by routine univariate descriptive analysis. Doppler values, which represent the main predictive parameter of study in order to find a possible association with the outcome of interest, will be analyzed longitudinally by means of a mixed linear model, a multivariate model capable of evaluating at the same time both the values of the exploratory variable of interest (Doppler) and possible covariates.
In addition, the mixed model is also capable of evaluating the "individual-specific" or random effect, the purpose of which is to isolate as precisely as possible the effect due to the variable hypothesized to be predictive toward the outcome of interest. In order to evaluate the hypothetically aberrant Doppler value compared to the expected normal value, a physiological control population will be recruited for both outcome and Doppler values.
Measured: From the 13th to the 24th weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Fetal DeathStudies 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
- Retrospective
- Enrolment
- 4,863 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Farina, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825481
- Sponsor's protocol ID
- StUtDop1.0
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2024
- Last updated
- 13 Feb 2025
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Doppler As StillbirthPredictor
- ClinicalTrials.gov ID
- NCT06825481
- Acronym / sponsor ID
- StUtDop1.0
- Conditions
- Intrauterine Fetal Death
- Keywords
- Uterine Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,863 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Feb 2025 (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 define the predictive value of intrauterine fetal death for different longitudinal patterns of uterine artery Doppler indices (UtA-PI, UtA-RI and notch) from the second and third trimester of pregnancy in patients admitted with a diagnosis of intrauterine foetal death in the period January 2010-April 2020.
Detailed description
No changes in the obstetrical conduct of patients with MEFs are expected, since the data will be analysed retrospectively in patients in whom the event of intrauterine foetal death has already occurred. Patients will be treated according to normal clinical protocols.
The following information will be recorded for each patient
- Age
- Body mass index (BMI)
- Ethnicity
- Parity
- Method of pregnancy onset (spontaneous vs. medically assisted procreation)
- Maternal pathologies (if any)
- Any foetal pathologies
- Ultrasound parameters in the second and third trimester of pregnancy
- Estimation of fetal weight
- Umbilical artery Doppler (UA-PI)
- Uterine artery Doppler (UtA-PI, UtA-RI and notch)
- Gestational age of fetal endouterine death
- Type of delivery
- Newborn and placental weight
- Histopathological findings of newborn and annexes (placenta and umbilical cord)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Assuming a standard deviation of 0.5 in the Doppler values of both cases and controls and a difference in the intercepts of 30% of the two regression lines, it is estimated that 72 cases and 4791 controls are needed to obtain a power of 80% at a type I error of 5%. The controls will be represented by the Doppler values reported in the literature for pregnancies not complicated by MEF.
Key inclusion criteria (2 listed)
- Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks
- Obtaining informed consent form
Key exclusion criteria (1 listed)
- Multiple pregnancies
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
Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF
Time frame: From the 13th to the 24th weeks of pregnancy
Data will be analyzed by routine univariate descriptive analysis. Doppler values, which represent the main predictive parameter of study in order to find a possible association with the outcome of interest, will be analyzed longitudinally by means of a mixed linear model, a multivariate model capable of evaluating at the same time both the values of the exploratory variable of interest (Doppler) and possible covariates. In addition, the mixed model is also capable of evaluating the "individual-specific" or random effect, the purpose of which is to isolate as precisely as possible the effect due to the variable hypothesized to be predictive toward the outcome of interest. In order to evaluate the hypothetically aberrant Doppler value compared to the expected normal value, a physiological control population will be recruited for both outcome and Doppler values.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
Antonio Farina, 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 Intrauterine Fetal Death, 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 2 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: status not confirmed, as of the sponsor's last update on 13 Feb 2025. 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 Farina, MD (+390512143110, antonio.farina@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF (time frame: From the 13th to the 24th weeks 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 13 Feb 2025.