Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

Assistance Publique - Hôpitaux de Paris82 enrolled

Overview

The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome.

Intra-uterine growth restriction is associated with an increased risk of perinatal morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal well-being and to evaluate ability to adapt to chronic hypoxia. The primary objective in antenatal care is to ischemic cerebral lesions. However, there is currently no relevant prenatal exam predictive for the risk of such lesions. Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some frontal cerebral territories in foetuses with intra-uterine growth restriction and poor neonatal outcome. These changes could be associated with a transient cerebral ischemia. The study of ADC could be a useful tool in the prognostic evaluation of these foetuses.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction

Interventions

Pregnant women with intra-uterine growth restricted FoetusesRADIATION

Diffusion-weighted cerebral MRI before 32 weeks of gestation

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * single pregnancy * estimated foetal weight ≤ 5th percentile * agreeing to participate * women age ≥ 18 years of age, speaking and understanding French language * covered by the French social security system Exclusion Criteria: * foetal malformation or foetal karyotype abnormal * infectious foetopathy * multiple pregnancy * refusal to participate * pregnant women aged \< 18 years old * pregnant women not understanding or speaking French language * not covered by French social security * contraindication to MRI

Locations (1)

Hôpital Armand Trousseau

Paris, France

Outcomes

Primary Outcomes

Poor neonatal status

Neonatal death; Apgar score \< 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH \< 7.10

Time frame: At birth

Secondary Outcomes

Poor neonatal status

Necrositing enterocolitis with need for surgical intervention; convulsions; intraventricular haemorrhage (type I to IV); periventricular leukomalacia (diagnosed by MRI); transfer to neonatal intensive care unit

Time frame: until 30 days of life

Neonatal status at neonatology unit discharge

Neurological status: normal / abnormal; need in O2: Yes/No

Time frame: up to 20 weeks

Neurological development

Age and stages questionnaire (ASQ)

Time frame: At 2 years of age (adjusted age)

Data from ClinicalTrials.gov

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