Clinical Trial: Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Poor neonatal status [ Time Frame: At birth ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Neonatal status at neonatology unit discharge [ Time Frame: up to 20 weeks ]
    Neurological status: normal / abnormal; need in O2: Yes/No
  • Neurological development [ Time Frame: At 2 years of age (adjusted age) ]
    Age and stages questionnaire (ASQ)


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 17, 2014
Date Started: March 2015
Date Completion: January 2020
Last Updated: July 31, 2016
Last Verified: July 2016