Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

Not Applicable

Completed

• Conditions: Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
• Interventions: Radiation: Pregnant women with intra-uterine growth restricted Foetuses

• Registration Number: NCT02229630
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-01
• Study Start: 2015-03-11
• Primary Completion: 2017-10-29
• Study Completion: 2019-10-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Pregnant women with intra-uterine growth restricted Foetuses	Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight \< 5th percentile (Hadlock calculator)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Neonatal status at neonatology unit discharge	up to 20 weeks	Neurological status: normal / abnormal; need in O2: Yes/No
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
Neurological development	At 2 years of age (adjusted age)	Age and stages questionnaire (ASQ)

Trial Locations

Locations (1)

Hôpital Armand Trousseau; 🇫🇷 Paris, France