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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229630
Recruitment Status : Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Hôpital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Jean-Marie Jouannic, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02229630    
Other Study ID Numbers: P130915
IDRCB: 2014-A00640-47
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
intra-uterine growth restriction
MRI
apparent diffusion coefficient
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes