Clinical trial NCT02813525: 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
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IUGR
Keywords: Aortic Isthmus
Isthmic Systolic Index
feasibility
reproducibility
mortality
delivery
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vascular IURG fetuses and patients with non-IUGR fetuses.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 3 months
Secondary outcomes:
measure: Assess the feasibility of the Doppler and the measure of the parameter
timeFrame: Up to 3 months
measure: Compare the reproducibility of the measurement between sonographers with different levels of expertise
timeFrame: Up to 3 months
measure: Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de gynécologie-obstétrique et de médecine fœtale
Study officials:
affiliation: University Hospital Bordeaux, France
name: Paul PEREZ, MD
role: STUDY_CHAIR
References: