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Clinical Trials in Italy / NCT06825481
Starting soon Observational

Uterine Doppler As StillbirthPredictor

NCT06825481 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2025-03-01
Last updated
2025-02-13

Condition(s) studied

Intrauterine Fetal Death

Study 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 period January 2010-April 2020.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks * Obtaining informed consent form Exclusion Criteria: * Multiple pregnancies

Primary outcome measure(s)

  • Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06825481 on ClinicalTrials.gov ↗ ← All trials in Italy