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Ultrasound Evaluation of Fetal Hemodynamics and Perinatal Complications

NCT03865628 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2019-03-07

No results posted yet for this study

Summary

In case of fetal weight below the 10th centile for gestational age, it is important to distinguish SGA and IUGR. SGA is defined as a fetal weight below the 10th centile. IUGR correspond to a pathologic reduction of growth velocity and it is a major determinant of perinatal mortality and morbidity. Even if SGA have long time been considered to be constitutionally small without adverse outcomes, recent evidence has demonstrated that a proportion of SGA, with normal UA Doppler, could be associated with neonatal adverse outcomes, probably related to a late-onset IUGR. Therefore, it seems essential to differentiate several categories of fetuses presenting abnormal fetal weight or intrauterine growth: fetuses SGA without any Doppler abnormalities, fetuses affected by early or late-IUGR. In case of late-IUGR, an important part of these fetuses is initially considered as PAG with a normal umbilical Doppler.

In case of fetal weight below the 10th centile for gestational age, longitudinal assessment of the fetal weight and umbilical artery (UA) Doppler is recommended. In case of abnormal UA Doppler, Middle Cerebral Artery (MCA) Doppler is recommended to research a "brain-sparing" effect. If UA and MCA Doppler findings seem to become abnormal in the early stages of IUGR, Ductus Venosus (DV) flow abnormalities have been described as a late marker of fetal decompensation related to an acute myocardial impaired relaxation and acidemia which is a major contributor to adverse perinatal outcome and neurological. The aortic isthmus (AoI) Doppler is an indicator of the progression of fetal hemodynamic deterioration in IUGR and recent data confirm that AoI and DV abnormalities are correlated but AoI Doppler abnormalities would occur earlier than DV Doppler. AoI Doppler could identify abnormalities suggestive of right ventricular dysfunction before DV Doppler and anticipate obstetrical management. In conclusion, Doppler examination could not be reduced to UA Doppler in case of SGA and IUGR and require a global examination including MCA and probably DV and AoI Doppler.

That's why fetal growth assessment should not be limited to fetal biometry and umbilical artery Doppler. Thanks to a systematic protocol for Doppler examination based on UA, MCA, DV and Aortic Isthmus (AoI) Doppler, we hope identify these hemodynamic variations in a large cohort of fetuses \<10 to improve prenatal assessment of these foetus to and perinatal outcomes, reducing perinatal morbi-mortality.

Conditions

  • Intrauterine Growth Restriction
  • Small-for-gestational Age

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • Centre Hospitalier Auxerre

    collaborator UNKNOWN

  • Hopital Nord Franche-Comte

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-08-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865628 on ClinicalTrials.gov