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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB: 2014-A00640-47 |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Experimental | Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregnant women with intra-uterine growth restricted Foetuses | Radiation | Diffusion-weighted cerebral MRI before 32 weeks of gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Poor neonatal status | Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10 | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | until 30 days of life |
| Neonatal status at neonatology unit discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marie Jouannic, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Armand Trousseau | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15302194 | Background | 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. | |
| 21177352 | Background |
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Neurological status: normal / abnormal; need in O2: Yes/No |
| up to 20 weeks |
| Neurological development | Age and stages questionnaire (ASQ) | At 2 years of age (adjusted age) |
| 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. |
| 22744761 | Background | 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. |
| 38735121 | Result | Xu E, Jouannic JM, Alison M, Ancel PY, Friszer S, Rousseau J, Guilbaud L, Adamsbaum C, Goffinet F, Blondiaux E. Analysis of MRI brain biometrics in fetuses monitored for intra uterine growth restriction and their prognostic value: Results of a prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2024 Jul;298:91-97. doi: 10.1016/j.ejogrb.2024.04.043. Epub 2024 Apr 30. |
| 31765031 | Result | 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. |