Diastolic Deceleration Area in Early-onset FGR

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-19

Study Completion Date

2024-04-01

Brief Summary

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DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Early-onset SGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an important role in the detection of hypoxia, anemia, and brain-sparing.

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Detailed Description

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Conditions

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Hypoxia Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Standard care:

* Doppler velocimetry: UA \& MCA PI, DV PIV, CPR;
* Indirect cardiotocography (CTG)
* Biophysical profile (BPP)

No interventions assigned to this group

DDA Doppler group

Standard care plus DDA Doppler monitoring

DDA Doppler

Intervention Type DIAGNOSTIC_TEST

A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.

Interventions

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DDA Doppler

A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* absence of fetal abnormalities and/or genetic conditions;
* single pregnancy;
* fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms, appearing before 32nd week of gestation

Exclusion Criteria

* documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;
* multiple pregnancy;
* absence of fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms before 32nd week of gestation

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No