Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
Conditions
Keywords
intra-uterine growth restriction, MRI, apparent diffusion coefficient
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.
Interventions
RADIATIONPregnant women with intra-uterine growth restricted Foetuses
Diffusion-weighted cerebral MRI before 32 weeks of gestation
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Poor neonatal status | At birth | Neonatal death; Apgar score \< 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH \< 7.10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Poor neonatal status | 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 | up to 20 weeks | Neurological status: normal / abnormal; need in O2: Yes/No |
| Neurological development | At 2 years of age (adjusted age) | Age and stages questionnaire (ASQ) |
Countries
France
Outcome results
None listed