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

NCT ID: NCT02813525

Last Updated: 2016-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

IUGR

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

ISI index on Doppler systolic flow in the aortic isthmus

Intervention Type: OTHER

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)

ISI index on Doppler systolic flow in the aortic isthmus

Intervention Type: OTHER

Measure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul PEREZ, MD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Locations

Service de gynécologie-obstétrique et de médecine fœtale

Bordeaux, , France

Countries

France

Central Contacts

Julie THOMAS, MD

Role: CONTACT

julie.thomas@chu-bordeaux.fr

(0)557656109 ext. +33

Lorena SANCHEZ BLANCO

Role: CONTACT

lorena.sanchez-blanco@chu-bordeaux.fr

(0)557656110 ext. +33

Facility Contacts

Julie THOMAS, MD

Role: primary

julie.thomas@chu-bordeaux.fr

(0)5 57 65 61 09 ext. +33

Lorena SANCHEZ BLANCO

Role: backup

lorena.sanchez-blanco@chu-bordeaux.fr

(0)557656110 ext. +33

Other Identifiers

CHUBX 2014/16

Identifier Type: -

Identifier Source: org_study_id