Uterine Doppler As StillbirthPredictor

NCT ID: NCT06825481

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4863 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Intrauterine Fetal Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Multiple pregnancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Farina, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status

Countries

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Italy

Central Contacts

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Antonio Farina, MD

Role: CONTACT

+390512143110

Facility Contacts

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Antonio Farina, MD

Role: primary

+390512143110

Other Identifiers

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StUtDop1.0

Identifier Type: -

Identifier Source: org_study_id

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