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OpenTrials
Completed

NCT Number: NCT02229630

Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Armand Trousseau

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregnant women with intra-uterine growth restricted Foetuses

Radiation

Diffusion-weighted cerebral MRI before 32 weeks of gestation

Other names: cerebral MRI

Primary outcomes

  1. Poor neonatal status

    Time frame: At birth

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

Secondary outcomes

  1. Poor neonatal status

    Time frame: until 30 days of life

    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

  2. Neonatal status at neonatology unit discharge

    Time frame: up to 20 weeks

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

  3. Neurological development

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

    Age and stages questionnaire (ASQ)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: REDIFF

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Sep 1, 2014
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.