Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction. (REDIFF)
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|ClinicalTrials.gov Identifier: NCT02229630|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction||Radiation: Pregnant women with intra-uterine growth restricted Foetuses||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.|
|Actual Study Start Date :||March 11, 2015|
|Actual Primary Completion Date :||October 29, 2017|
|Estimated Study Completion Date :||December 2019|
Experimental: Pregnant women
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
Diffusion-weighted cerebral MRI before 32 weeks of gestation
Other Name: cerebral MRI
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229630
|Hôpital Armand Trousseau|
|Paris, France, 75012|
|Principal Investigator:||Jean-Marie Jouannic, MD, PhD||Assistance Publique - Hôpitaux de Paris|