WithdrawnNot Applicable

Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations

Stopped: Study manager's decision

France0Started 2020-05

Plain-language summary

The objective is to evaluate the quality of the response to the Blood Oxygen Level Dependent effect in fetuses with diaphragmatic hernias and abdominal wall malformations and to correlate with postnatal respiratory outcome. Pulmonary involvement is a constant in diaphragmatic hernias, it is classic in omphaloceles and especially hepatomphaloceles, and exceptional in laparoschisis. As this is an original exploratory study, no preliminary data are available. If a correlation is found, the Blood Oxygen Level Dependent effect of the fetal lung may be considered as an early functional marker of postnatal lung function. It can be used in addition to lung-to-head-ratio during prenatal counseling. The final goal is to be able to detect early in the fetus pulmonary insufficiency to help prenatal counseling and perinatal care.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Major patient, * patient with a simple pregnancy, * patient between 28 and 33 weeks of amenorrhea, * patient undergoing fetal MRI as part of their usual care, for fetal / placental indications : diaphragmatic hernia, omphalocele and laparoschisis, * informed consent signed by the patient and the investigator, * patient affiliated to a social security scheme (beneficiary or beneficiary). Exclusion Criteria: * Patient with one of the usual contraindications for MRI, * claustrophobic patient, * patient with an abdominal perimeter\> 125 cm, * patient with multiple-birth pregnancy, * patient with a pregnancy at the end of a long course of medical assisted procreation, * patient with chronic respiratory disease.

What they're measuring

Value of the Blood Oxygenation Level Dependent of the fetal lung

Timeframe: 30 months

Postnatal respiratory evolution

Timeframe: 30 months

Trial details

NCT IDNCT04186039

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05