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Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality (f-ISI-RCIU)

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ClinicalTrials.gov Identifier: NCT02813525
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Bordeaux.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.

Condition or disease Intervention/treatment
IUGR Other: ISI index on Doppler systolic flow in the aortic isthmus

Detailed Description:

Today evaluating the hemodynamic tolerance of the fetus with IUGR, is based on clinical evidence of fetal well-being and ultrasound arguments, since we know in fact that there is a correlation between Doppler indices of cardiovascular function and perinatal mortality.

The flow to the systolic aortic isthmus may be a marker of systolic performance balance of both ventricles. An index of systolic flow velocities (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia.

The strategy evaluates the feasibility of measuring the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus with IUGR due to placental insufficiency.

The ISI is obtained from this flow by calculating the ratio of the minimum systolic velocity (called Nadir) on the peak systolic velocity (called Peak) or Nadir / Peak. The fetal extraction decision (birth) will be taken, blinded the outcome of the ISI, following the protocol of national recommendations for the management of fetuses with IUGR.

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
IUGR group
estimated fetal weight <10th percentile associated with an abnormal umbilical artery Doppler with IP>95th percentile or a confirmation of placental vascular disease by histological examination
Other: ISI index on Doppler systolic flow in the aortic isthmus
Measure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus

CONTROL group
non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)
Other: ISI index on Doppler systolic flow in the aortic isthmus
Measure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus




Primary Outcome Measures :
  1. Compare the evolution of the values of the ISI in the fetus with IUGR relative to those of fetuses without IUGR fetuses for the same gestational age [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Assess the feasibility of the Doppler and the measure of the parameter [ Time Frame: Up to 3 months ]
    • Obtaining of the sagittal cup or the cross-functional cup of the aortic arch (conformity : yes/no, obtaining: very easy, easy, little easy, difficult, very difficult, impossible).
    • Positioning of the shooting doppler: very easy, easy, little easy, difficult, very difficult, impossible.
    • Doppler flow for the isthmus: conformity yes/no.
    • ISI Measure : very easy, easy, little easy, difficult, very difficult, impossible·
    • Time necessary to obtain the measure (including obtaining of the cup of the aortic arch in sagittal or cross-functional and the measure of the velocities on the Doppler flow).

  2. Compare the reproducibility of the measurement between sonographers with different levels of expertise [ Time Frame: Up to 3 months ]
  3. Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality [ Time Frame: Up to 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with vascular IURG fetuses and patients with non-IUGR fetuses.
Criteria

Inclusion Criteria:

  • Gestational age determined by ultrasound dating of the first quarter
  • IUGR group: estimated fetal weight <10th percentile associated with

    • An abnormal umbilical artery Doppler with pulsatility index >95th percentile
    • OR a confirmation of placental vascular disease by histological examination
  • CONTROL group: non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)

Exclusion Criteria:

  • Twin or multiple pregnancy,
  • Fetal weight> 10th percentile
  • Presence of fetal infection
  • Structural fetal anomaly or fetal chromosomal abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813525


Contacts
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Contact: Julie THOMAS, MD (0)557656109 ext +33 julie.thomas@chu-bordeaux.fr
Contact: Lorena SANCHEZ BLANCO (0)557656110 ext +33 lorena.sanchez-blanco@chu-bordeaux.fr

Locations
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France
Service de gynécologie-obstétrique et de médecine fœtale
Bordeaux, France
Contact: Julie THOMAS, MD    (0)5 57 65 61 09 ext +33    julie.thomas@chu-bordeaux.fr   
Contact: Lorena SANCHEZ BLANCO    (0)557656110 ext +33    lorena.sanchez-blanco@chu-bordeaux.fr   
Principal Investigator: Julie THOMAS, MD         
Sub-Investigator: Frédéric COATLEVEN, MD         
Sub-Investigator: Marie-Anne COUSTEL, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Paul PEREZ, MD University Hospital Bordeaux, France
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02813525    
Other Study ID Numbers: CHUBX 2014/16
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Bordeaux:
Aortic Isthmus
Isthmic Systolic Index
feasibility
reproducibility
mortality
delivery
Additional relevant MeSH terms:
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Perinatal Death
Fetal Growth Retardation
Pregnancy Complications
Death
Pathologic Processes
Fetal Diseases
Growth Disorders