Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-11

Study Completion Date

2019-10-17

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.

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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.

Conditions

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Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pregnant women

Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight \< 5th percentile (Hadlock calculator)

Group Type EXPERIMENTAL

Pregnant women with intra-uterine growth restricted Foetuses

Intervention Type RADIATION

Diffusion-weighted cerebral MRI before 32 weeks of gestation

Interventions

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Pregnant women with intra-uterine growth restricted Foetuses

Diffusion-weighted cerebral MRI before 32 weeks of gestation

Intervention Type RADIATION

Other Intervention Names

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cerebral MRI

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No