Ultrasound Evaluation of Fetal Hemodynamics and Perinatal Complications

NCT03865628 | Unknown

• 1 other identifier: API/2017/89
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Doppler; Ombilical artery; Middel cerebral artery; Ductus venous; Aortic isthmus; Amniotic fluid; Intrauterine Growth Restriction; Small-for-gestational Age; Prognosis

Outcome Measures

Primary Outcomes (1)

• Global perinatal morbidity and mortality

  Defined by the occurrence of at least one of the following events (composite outcome of the french national epidemiological study "EPIPAGE"): * perinatal death * stage 3 or 4 intraventricular haemorrhage * cystic periventricular leukomalacia * hyperoxic retinopathy treated using laser * ulcerative necrotizing enterocolitis * bronchopulmonary dysplasia

  1 month after birth

Secondary Outcomes (2)

• Specific perinatal morbidity and mortality

  1 month after birth

• Early neonatal morbidity

  1 week after birth

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population correspond to the patients follow up in one of the materno-fetal medicine unit, multidisciplinary reference unit for the diagnosis, the investigation and management of materno-fetal diseases.

You may qualify if:

• Singleton pregnancy
• Estimation of the fetal weight less than estimation the 10th percentile

You may not qualify if:

• Refusal of parents
• Fetal and vascular malformations
• Fetal anemia

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Centre Hospitalier Universitaire Dijon: collaborator
• University Hospital, Strasbourg, France: collaborator
• Centre Hospitalier Auxerre: collaborator
• Hopital Nord Franche-Comte: collaborator

Related Publications (5)

• Meher S, Hernandez-Andrade E, Basheer SN, Lees C. Impact of cerebral redistribution on neurodevelopmental outcome in small-for-gestational-age or growth-restricted babies: a systematic review. Ultrasound Obstet Gynecol. 2015 Oct;46(4):398-404. doi: 10.1002/uog.14818.

  PMID: 25683973 BACKGROUND

• Benavides-Serralde A, Scheier M, Cruz-Martinez R, Crispi F, Figueras F, Gratacos E, Hernandez-Andrade E. Changes in central and peripheral circulation in intrauterine growth-restricted fetuses at different stages of umbilical artery flow deterioration: new fetal cardiac and brain parameters. Gynecol Obstet Invest. 2011;71(4):274-80. doi: 10.1159/000323548. Epub 2011 Feb 24.

  PMID: 21346314 BACKGROUND

• Figueras F, Benavides A, Del Rio M, Crispi F, Eixarch E, Martinez JM, Hernandez-Andrade E, Gratacos E. Monitoring of fetuses with intrauterine growth restriction: longitudinal changes in ductus venosus and aortic isthmus flow. Ultrasound Obstet Gynecol. 2009 Jan;33(1):39-43. doi: 10.1002/uog.6278.

  PMID: 19115231 BACKGROUND

• Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Oros D, Gratacos E. Changes in myocardial performance index and aortic isthmus and ductus venosus Doppler in term, small-for-gestational age fetuses with normal umbilical artery pulsatility index. Ultrasound Obstet Gynecol. 2011 Oct;38(4):400-5. doi: 10.1002/uog.8976. Epub 2011 Jul 26.

  PMID: 21567514 BACKGROUND

• Baschat AA. Planning management and delivery of the growth-restricted fetus. Best Pract Res Clin Obstet Gynaecol. 2018 May;49:53-65. doi: 10.1016/j.bpobgyn.2018.02.009. Epub 2018 Mar 1.

  PMID: 29606482 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas MOTTET, MD

CONTACT

03 81 21 88 95; ncmottet@gmail.com

Louis BENAZET

CONTACT

03 81 21 91 47; lbenazet@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: March 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share