Uterine Doppler As StillbirthPredictor

Not yet recruiting

• Conditions: Intrauterine Fetal Death

• Registration Number: NCT06825481
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4863

Inclusion Criteria

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

Exclusion Criteria

• Multiple pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF	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.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy