A MotherToBaby Pregnancy Study is an observational research study that collects information from a mom-to-be during her pregnancy along with information about her baby’s health after the pregnancy is over.
Observational research means we do not ask our study participants to take any medications or change any part of their medical or daily routine. Rather, moms-to-be who tell us that they have a specific health condition or that they have been exposed to a specific medicine or vaccine are followed by our research team through the remainder of their pregnancy, and their babies are followed for a period of time after birth.
9 out of 10 women in the United States take a medication during pregnancy; that means 5.4 million pregnancies are exposed to medications each year! But pregnant women cannot currently participate in the clinical trials that occur when a drug is being developed; this means that once the medication is approved by the US Food & Drug Administration, it starts being prescribed to patients who need it, with no information whatsoever on the safety of the medication if it is used during a pregnancy.
Our MotherToBaby Pregnancy Studies aim to provide this much-needed information. Our goal is to help women and their doctors get the information they need to make more informed treatment decisions during pregnancy.
First, just let us know that you are interested in participating. We’ll arrange a time to speak with you and get some more information to see if you are eligible. If you are eligible to join, we then tell you exactly what is involved in the study so you can decide if you want to participate.
If you decide to join the study, you’ll be asked to participate in 2-4 interviews up until delivery and there may be additional interviews after delivery; these interviews will take place at different points in time during your pregnancy and after your pregnancy is over. We will also ask for your permission to obtain a copy of your and your baby’s medical records from your healthcare provider. These interviews and your medical records are critically important to our research.
Remember: You will not be asked to take any new medicines, experimental drugs or to change any part of your routine!
The MotherToBaby research team views privacy as one of our most important considerations when dealing with your personal health information. We are required by law to comply with the strict rules and regulations set forth by state and federal agencies as well as the Institutional Review Board (IRB) at the University of California, San Diego, who oversees and monitors our research protocols.
Information that we obtain from your interviews and your medical records is vital to helping us determine the effects of health conditions in pregnancy. All of your personal health information will be kept confidential.
Once you agree to participate in a study, we will need your written permission to obtain medical records for your pregnancy and your baby; we will give you detailed information about who will have access to your health information and how the information will be used in ways that will continue to protect your privacy.
We’ll ask you questions about your health history, your pregnancy and the birth of your child. You’ll be asked about exposures to medications, chemicals, illnesses and other environmental agents during your pregnancy, along with the dates when the exposures occurred and the dose and amount of exposure.
There are many benefits women receive from participating! All participants have access to friendly and knowledgeable information specialists who can answer any questions you might have about exposures during pregnancy and while breastfeeding, all at no cost to you.
You may also be eligible to receive a free in-home examination of your baby by one of our pediatric specialists. Many participants tell us that the reassurance of this assessment has brought them peace of mind that lasts a lifetime.
You may have an exciting opportunity to learn about your baby’s developmental milestones by completing one or more specially designed questionnaires.
Last, but perhaps most importantly, many of our participating moms-to-be feel pride and satisfaction knowing that they’re providing information that can help future moms and babies.
Yes! We send study participants and their health care providers the results of the study. This information might prove useful to you in a possible future pregnancy, and may be used by your healthcare provider when treating other patients like you.
You can contact MotherToBaby Pregnancy Studies toll-free at 877.311.8972 or by email at mothertobaby@ucsd.edu.
The US Food and Drug Administration (FDA) has a list of all pregnancy studies (called “pregnancy registries”) that are currently enrolling pregnant women. Our MotherToBaby Pregnancy Studies are listed there, in addition to those conducted by other organizations. To learn more, visit http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134848.htm.
MotherToBaby has information specialists who can answer your questions, even if you decide not to participate in our studies. These include questions you might have about prescription and over-the-counter medications, infections and vaccines, recreational substances, herbal products, and much more. The information we provide is evidence-based and up-to-date. Contact one of our experts for free and confidential services by visiting our Ask An Expert page.
