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Not yet recruiting NCT06825481

Uterine Doppler As StillbirthPredictor

Observational Intrauterine Fetal Death

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intrauterine Fetal Death. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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)

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06825481 · StUtDop1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗