Clinical trial NCT02229630: Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.
Official title: Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
Keywords: intra-uterine growth restriction
MRI
apparent diffusion coefficient
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-09-01
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Poor neonatal status
timeFrame: At birth
Secondary outcomes:
measure: Poor neonatal status
timeFrame: until 30 days of life
measure: Neonatal status at neonatology unit discharge
timeFrame: up to 20 weeks
measure: Neurological development
timeFrame: At 2 years of age (adjusted age)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Armand Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marie Jouannic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.