Clinical Trials for Pregnant Women: FAQs

There are some risks with MRI that are easy to avoid and very rarely cause harm when MRI is performed within established guidelines by trained professionals. MRI uses a powerful magnet, so anyone with metal implants, such as certain types of surgical clips or pacemakers, should not have an MRI.

Other metal objects, such as keys, pocket knives, or certain types of jewelry, must be removed prior to entering the magnet room. You and your newborn will be screened for these kinds of objects before your MRI.

The MRI scanner also uses radio frequency waves that can, on rare occasions, cause a mild warming sensation similar to what you feel on a warm day at the beach. The MRI scanner may be noisy, so we will provide you or your newborn with earplugs to reduce the noise.

Some people simply find it uncomfortable and/or claustrophobic to lie in the close space of the MRI scanner. If you get nervous or upset during the MRI, the procedure will be stopped. If your baby becomes upset during the MRI, we will stop the exam until the baby goes back to sleep.

MRI (magnetic resonance imaging) is a technique that uses a magnetic field and radio waves to take detailed images of the inside of the body. MRI is considered harmless because it does not involve exposure to radiation, which can be a concern with X-rays.

Fetal MRI is used to take pictures of the developing baby during pregnancy. Presently, there is no evidence that there is any harm from MRI procedures to unborn babies.

Our radiology team is very experienced and has performed fetal MRIs for more than seven years. Children's National is also one of the few centers nationally that provides combined fetal MRI imaging and ultrasound.

Neither you nor your baby will receive any sedation or any other medicine during the procedure. At worst, you may experience discomfort from lying on your back or feelings of claustrophobia (fear of being in a closed space) during the exam.

You will be given a buzzer that you can push to alert the technologist to your discomfort, and the scan can be temporarily stopped until you feel ready to continue. You also will be given earplugs to protect your ears from the loud noises made by the machine.

Approximately 140 mother/baby pairs have already participated at outside institutions without any adverse events. We hope to enroll a total of 200 babies in our studies.

No. The fetal MRI is paid for by funds from our research grant. For babies with heart problems, the preoperative MRI is billed to you or your health insurance company through routine billing channels because it is part of the routine care your baby receives at Children's National.

The 12- to 18-month developmental follow-up visit also is covered by our research grant. For healthy volunteers, both the fetal MRI and newborn MRI studies are covered by the research grant.

We will provide you with a parking sticker to cover your parking cost for each of your study visits.

Although our focus population is babies with heart problems, we also enroll mothers of babies with healthy hearts in our studies. It is important for us to understand brain growth and development in babies with healthy hearts so that we can evaluate whether any changes in brain development occur in babies with congenital heart disease.

It is our long-term goal to be able to identify babies with impaired brain growth as soon as possible, so that the proper interventions and clinical planning can take place.

You are eligible to participate in our fetal MRI studies if you are:

• Between 18 and 40 weeks pregnant with a single baby
• Have had normal ultrasound studies of your baby
• Are not on any medications that may interfere with your pregnancy
• Do not have any health conditions that may complicate your pregnancy, such as diabetes or chronic hypertension

We will make the results of the MRI studies available to you and your baby's doctors. We also will send you a photo of your baby from your fetal MRI study.

If any problems are identified on either MRI scan, we will discuss the findings with you and make the appropriate recommendations and referrals. We will also provide you with electronic and paper copies of some of the images taken of your baby during the fetal MRI.

By participating in our studies, you and your baby will help advance medical knowledge about brain development in infants diagnosed with a heart problem. We believe that this knowledge will ultimately allow us to make decisions about the treatment of these infants that will improve the quality of their lives.

Children with heart problems could benefit from the comprehensive series of developmental evaluations performed between 12 and 18 months of life. We will mail you a report summarizing the findings of the neurological and developmental testing, which you may choose to share with your pediatrician.

If any problems are identified in the developmental tests, we will discuss the findings with you. We will also make recommendations and referrals for appropriate early intervention services to minimize any developmental difficulties your child may be experiencing.