Uterine Doppler As StillbirthPredictor

February 11, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Not yet recruiting

Conditions

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)

Study Type

Observational

Enrollment (Estimated)

4863

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Assuming a standard deviation of 0.5 in the Doppler values of both cases and controls and a difference in the intercepts of 30% of the two regression lines, it is estimated that 72 cases and 4791 controls are needed to obtain a power of 80% at a type I error of 5%. The controls will be represented by the Doppler values reported in the literature for pregnancies not complicated by MEF.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiple pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the 13th to the 24th weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Antonio Farina, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StUtDop1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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