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NCT Number: NCT06825481

Uterine Doppler As StillbirthPredictor

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.

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Key information

Conditions

Intrauterine Fetal Death Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Stillbirth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks
  • Obtaining informed consent form

Exclusion criteria

  • Multiple pregnancies

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Farina, MD

CONTACT

[email protected]

+390512143110

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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