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

NCT02813525 | Unknown

• 1 other identifier: CHUBX 2014/16
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

IUGR

Keywords

Aortic Isthmus; Isthmic Systolic Index; feasibility; reproducibility; mortality; delivery

Outcome Measures

Primary Outcomes (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

  Up to 3 months

Secondary Outcomes (3)

• Assess the feasibility of the Doppler and the measure of the parameter

  Up to 3 months

• Compare the reproducibility of the measurement between sonographers with different levels of expertise

  Up to 3 months

• Estimate the association between ISI index and perinatal mortality and the performance of the ISI in predicting perinatal mortality

  Up to 3 months

Study Arms (2)

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

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

Interventions

ISI index on Doppler systolic flow in the aortic isthmus 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; IUGR group

Eligibility Criteria

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

Study Population

Patients with vascular IURG fetuses and patients with non-IUGR fetuses.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service de gynécologie-obstétrique et de médecine fœtale

Bordeaux, France

Location

Study Officials

• Paul PEREZ, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Central Study Contacts

Julie THOMAS, MD

CONTACT

(0)557656109; julie.thomas@chu-bordeaux.fr

Lorena SANCHEZ BLANCO

CONTACT

(0)557656110; lorena.sanchez-blanco@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 27, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 27, 2016

Record last verified: 2016-06

Locations

FR (1)