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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

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE September 1, 2014
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE March 11, 2015
Actual Primary Completion Date October 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
Poor neonatal status [ Time Frame: At birth ]
Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
Intervention  ICMJE Radiation: Pregnant women with intra-uterine growth restricted Foetuses
Diffusion-weighted cerebral MRI before 32 weeks of gestation
Other Name: cerebral MRI
Study Arms  ICMJE 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)
Intervention: Radiation: Pregnant women with intra-uterine growth restricted Foetuses
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 4, 2018)
82
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2014)
56
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date October 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229630
Other Study ID Numbers  ICMJE P130915
IDRCB: 2014-A00640-47
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Jean-Marie Jouannic, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP