Clinical Trials for Pregnant Women: What to Expect

The Developing Brain Institute is looking for women both with high-risk and normal pregnancies for our clinical trials. Our research studies are safe, painless and noninvasive.

Learn more about the clinical trials for pregnant women that we are currently recruiting for.

Before Your Baby is Born

You will meet with us on two occasions at Children's National where we will:

• Take special "pictures" (scans) of your baby's brain using MRI (magnetic resonance imaging). MRI is a technique that uses a magnetic field and radio waves to create detailed images of organs and tissues.
• Take pictures of your baby's heart using an echocardiogram (tests heart function using ultrasound waves that produce an image).
• Measure your baby's heartbeat using stickers placed on your belly.

A Guide To Your Fetal MRI

• The fetal MRI appointment takes about 1.5 hours, depending on how much your baby is moving. Please avoid caffeine for two hours prior to your appointment, because this helps to limit fetal motion and can help the scan run more smoothly and provide better images.
• When you arrive at the hospital, please check in at the nearest security desk and get an ID badge.
• The research coordinator will meet you at your appointment time in the Costco Wholesale Atrium/main lobby of the hospital, located on the first floor. This is the area where the gift shop is located and where the hot air balloons are hanging.
• If you are running late for your appointment or need to change it for any reason, please let the research coordinator know as soon as possible. MRI appointments are shared with clinical patients, so it is important that we are aware of any schedule changes.
• All patients will have a metal screening before entering the MRI room. If you wear jewelry or piercings to your appointment, we will ask you to remove them before your MRI. We will provide you with a locker to secure your belongings during the exam. The key is MRI safe, and you can take it with you into the room.
• One person may accompany you into the MRI room during your scan. This person will also have to be screened for metal before entering the MRI room.
• After the MRI, the research coordinator will show you some images of your baby taken during the scan. She will send some of these images to you via email soon after your appointment. You will also receive printed copies of these images in the mail shortly thereafter.
• A member of our study staff will call you within a week to discuss the results of your fetal MRI.

After Your Baby is Born

You and your baby will meet with us on two occasions. During the first weeks of your baby's life, we will:

• Take special "pictures" (scans) of your baby's brain during natural sleep using MRI.
• Conduct a brief physical exam of your baby.
• Take pictures of your baby's heart using an echocardiogram.
• Ask you questions about you and your baby's medical history.

A Guide To Your Newborn's MRI

• The newborn MRI appointment can take two to three hours because of the time it takes to feed and prepare the baby for the MRI and make sure he or she is comfortably asleep during the scan. The actual MRI scan time is less than an hour.
• Please adjust your baby's feeding schedule so that the baby is ready to eat shortly after you arrive for your appointment. If possible, feed the baby one hour before your arrival time, so that he or she will be ready to eat again before the MRI. You will have access to a private room for feeding. The baby will be more likely to fall asleep if he or she feeds right before the MRI scan.
• If you are running late for your appointment or need to change it for any reason, please let the research coordinator know as soon as possible. MRI appointments are shared with clinical patients, so it is important that we are aware of any schedule changes.
• When you arrive at the hospital, please check in at the nearest security desk and get an ID badge.
• The research coordinator will meet you at your appointment time in the Costco Atrium/main lobby of the hospital, located on the first floor. This is the area where the gift shop is located and where the hot air balloons are hanging.
• We will perform the neurobehavioral assessment either before or after the MRI scan, depending on when your baby is most alert. You can be present for this assessment.
• One person may accompany your baby into the MRI room during your scan. This person will have to be screened for metal before entering the MRI room.
• A member of our study staff will call you within a week to discuss the results of your baby's MRI.

Developmental Follow-up Exam

Your second visit with us will occur when your baby is 18 months old. During this visit, we will examine your baby to assess his or her development. Neither an MRI nor an echocardiogram will be necessary.

During the developmental follow-up exam, your second visit involves a play session between you and your child with our psychologist. During the play session, the psychologist will assess how your child is developing in relation to his or her peers.

The three areas that will be examined include:

• Motor skills
• Language development
• Cognitive skills

You will receive a report and feedback on your child's progress.

Joining Our Studies

Joining our studies will not: 

• Harm your baby in any way
• Change the way your doctors manage your pregnancy or your baby
• Expose you or your baby to any experimental medicines or procedures
• Involve needle sticks to you or your baby
• Require any blood samples taken from you or your baby
• Cost you or your insurance anything
• Expose you or your baby's identity to anyone outside the study