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

Primary Purpose

Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pregnant women with intra-uterine growth restricted Foetuses
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction focused on measuring intra-uterine growth restriction, MRI, apparent diffusion coefficient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Armand Trousseau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregnant women

Arm Description

Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Poor neonatal status
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
Neurological status: normal / abnormal; need in O2: Yes/No
Neurological development
Age and stages questionnaire (ASQ)

Full Information

First Posted
July 17, 2014
Last Updated
April 2, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02229630
Brief Title
Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.
Acronym
REDIFF
Official Title
Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
October 29, 2017 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
Keywords
intra-uterine growth restriction, MRI, apparent diffusion coefficient

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant women
Arm Type
Experimental
Arm Description
Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator)
Intervention Type
Radiation
Intervention Name(s)
Pregnant women with intra-uterine growth restricted Foetuses
Other Intervention Name(s)
cerebral MRI
Intervention Description
Diffusion-weighted cerebral MRI before 32 weeks of gestation
Primary Outcome Measure Information:
Title
Poor neonatal status
Description
Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10
Time Frame
At birth
Secondary Outcome Measure Information:
Title
Poor neonatal status
Description
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
Time Frame
until 30 days of life
Title
Neonatal status at neonatology unit discharge
Description
Neurological status: normal / abnormal; need in O2: Yes/No
Time Frame
up to 20 weeks
Title
Neurological development
Description
Age and stages questionnaire (ASQ)
Time Frame
At 2 years of age (adjusted age)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Jouannic, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15302194
Citation
Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.
Results Reference
background
PubMed Identifier
21177352
Citation
Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.
Results Reference
background
PubMed Identifier
22744761
Citation
Boyer AC, Goncalves LF, Lee W, Shetty A, Holman A, Yeo L, Romero R. Magnetic resonance diffusion-weighted imaging: reproducibility of regional apparent diffusion coefficients for the normal fetal brain. Ultrasound Obstet Gynecol. 2013 Feb;41(2):190-7. doi: 10.1002/uog.11219. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
31765031
Citation
Jouannic JM, Blondiaux E, Senat MV, Friszer S, Adamsbaum C, Rousseau J, Hornoy P, Letourneau A, de Laveaucoupet J, Lecarpentier E, Rosenblatt J, Quibel T, Mollot M, Ancel PY, Alison M, Goffinet F. Prognostic value of diffusion-weighted magnetic resonance imaging of brain in fetal growth restriction: results of prospective multicenter study. Ultrasound Obstet Gynecol. 2020 Dec;56(6):893-900. doi: 10.1002/uog.21926.
Results Reference
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Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

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