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Uterine Doppler As StillbirthPredictor

Uterine Doppler As StillbirthPredictor

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06825481
Enrollment
4863
Registered
2025-02-13
Start date
2025-03-01
Completion date
2026-03-01
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Fetal Death

Keywords

Uterine Doppler

Brief 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.

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)

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEFFrom the 13th to the 24th weeks of pregnancyData 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.

Countries

Italy

Contacts

Primary ContactAntonio Farina, MD
antonio.farina@unibo.it+390512143110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026