Using MRI to evaluate fetal health during pregnancy
LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI
This study is testing if using advanced MRI along with regular ultrasounds can help doctors find and diagnose problems in unborn babies better for pregnant women between 16 and 36 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04142606 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the detection and diagnosis of congenital anomalies in fetuses by utilizing advanced Magnetic Resonance Imaging (MRI) techniques alongside traditional ultrasound methods. The study will include pregnant patients between 16 and 36 weeks of gestation, collecting clinical, biological, and ultrasound data to analyze in conjunction with MRI findings. The goal is to enhance the anatomical and functional evaluation of fetal organs, ultimately improving perinatal outcomes. The study will ensure minimal loss to follow-up by maintaining standard perinatal surveillance practices.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with single or twin pregnancies between 16 and 36 weeks of gestation.
Not a fit: Patients with contraindications to MRI or those with multiple pregnancies greater than two will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better detection and management of congenital anomalies in fetuses, improving outcomes for affected infants.
How similar studies have performed: Other studies utilizing MRI for fetal evaluation have shown promising results, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient ≥ 18 years * Single or twin pregnancy * gestational age≥ 16 WG and ≤ 36 WG based on cranio-caudal length (LCC) dating * Collection of the patient's consent Exclusion Criteria: contraindication to MRI * multiple pregnancies \> 2 * subsequent follow-up impossible * maternal condition contraindicates continuation of pregnancy * patient having to have an MRI examination as part of the normal clinical follow-up of her pregnancy (identified or strongly suspected echocardiographic abnormality on ultrasound, diaphragmatic dome hernia, CMV fetal infection, antecedent brain abnormality in siblings, STT operated)
Where this trial is running
Paris
- Necker - Enfants Malades Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Laurent Salomon, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: David Grevent, MD PHD
- Email: david.grevent@gmail.com
- Phone: + 33144841734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.