Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.

Conditions
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Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction

Intervention / Treatment
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* Radiation: Pregnant women with intra-uterine growth restricted Foetuses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator) | Radiation: Pregnant women with intra-uterine growth restricted Foetuses<br>* Diffusion-weighted cerebral MRI before 32 weeks of gestation<br>* Other names: cerebral MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor neonatal status | Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10 | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until 30 days of life | 
| Neonatal status at neonatology unit discharge | Neurological status: normal / abnormal; need in O2: Yes/No | up to 20 weeks | 
| Neurological development | Age and stages questionnaire (ASQ) | At 2 years of age (adjusted age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, intra-uterine growth restriction, apparent diffusion coefficient