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)

University Hospital of Bordeaux

Status: Unknown

Conditions: IUGR

Treatments: Other: ISI index on Doppler systolic flow in the aortic isthmus

Study type: Observational

Funder types: Other

Identifiers

NCT02813525

CHUBX 2014/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 2 patient groups

IUGR group

Description:

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

Treatment:

Other: ISI index on Doppler systolic flow in the aortic isthmus

CONTROL group

Description:

non IUGR fetuses for gestational age (normal for weight, Doppler, and structural analyse)

Treatment:

Other: ISI index on Doppler systolic flow in the aortic isthmus