Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction. (REDIFF)

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

Treatments: Radiation: Pregnant women with intra-uterine growth restricted Foetuses

Study type: Interventional

Funder types: Other

Identifiers

NCT02229630

P130915

IDRCB: 2014-A00640-47

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Pregnant women

Experimental group

Description:

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

Treatment:

Radiation: Pregnant women with intra-uterine growth restricted Foetuses