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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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