CompletedNot Applicable

Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women

France101 participantsStarted 2015-02-18

Plain-language summary

The purpose of this study is to evaluate the use of functional MRI in pregnant women as a non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus when the mother is breathing pure oxygen. This study aims hence to demonstrate the difference in the BOLD effect between normal feto-placental units and growth restricted ones.

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 singleton pregnancy * Patient between 18 and 37 gestational weeks * Informed consent signed by the patient * Patient affiliated to a social security scheme (beneficiary or assignee) Specific criteria for patients with a eutrophic fetus * Patient with fetal eutrophic on sonographic fetal weight estimation Specific criteria for patients with an IUGR-fetus Patient with a fetus presenting intra-uterine growth restriction diagnosed by ultrasound (\<5th percentile). Exclusion Criteria: * Patient with the usual contra-indications for MRI * Patient with an abdominal circumference\> 125 cm * Patient with a multiple pregnancy * Patient with placenta accreta or percreta * Patient with a pregnancy after long history of infertility and medically assisted procreation

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

Highlight a placental BOLD effect

Timeframe: at inclusion

Trial details

NCT IDNCT02238301

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-26

View on ClinicalTrials.gov More Intrauterine Growth Restriction trials