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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.
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
Gestational age of fetal endouterine death
Type of delivery
Newborn and placental weight
Histopathological findings of newborn and annexes (placenta and umbilical cord)
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the association between uterine artery Doppler indexes (UtA-PI, UtA-RI and notch) and MEF | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Farina, MD | Contact | +390512143110 | antonio.farina@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Farina, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D050497 | Stillbirth |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |