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Last year I was pregnant with my first child. At the same time, I was going through the immigration process to apply for permanent residency in the United States. I wasn’t aware of the many things that you must do to get your health records cleared by immigration and how that process can be a great source of anxiety during pregnancy. If you are an immigrant, you may not have health insurance or cannot understand the language, which can be another challenge. In order to have sound and scientifically true advice during that critical period, I always consulted with my doctor and then MotherToBaby.

First, I was told that I needed to get revaccinated for certain diseases, even though I may have had them or may have been previously vaccinated in the past. Those vaccinations included measles, mumps and rubella (MMR), varicella, polio, tetanus diphtheria pertussis (Tdap), hepatitis B, and COVID-19. As soon as I heard this long list, I went online and checked the MotherToBaby facts sheets about those vaccines one by one to see what was known about their use in pregnancy. It turns out the Hepatitis B and COVID-19 vaccines are not associated with risk during pregnancy. Even more, it is recommended to get a Tdap vaccine during pregnancy to provide protective antibodies to your baby against pertussis (whopping cough). Live vaccines like MMR and varicella (chickenpox) are not recommended during pregnancy. Thankfully I was able to get bloodwork done to check antibody levels (protective proteins) showing prior protection. If you can show full protection, you no longer need to get vaccinated for these diseases after pregnancy. 

One other thing I had to find out was my tuberculosis (TB) status. This is done by blood work, but if the results don’t rule out the disease, you would need a lung x-ray. In general, X-rays are not recommended during pregnancy. However, if needed, studies show that a single chest x-ray is not associated with an increased risk for birth defects or pregnancy complications for the developing baby. It is important to know your tuberculosis status before pregnancy since active infection can be associated with preterm labor (early birth before 37 weeks), low birth weight of the baby, or even maternal death. Getting TB treated as soon as possible, even when you are pregnant, is so important. Tuberculosis is a slow-growing, pesky disease that is common in certain countries, including my home country, Turkey, but not common in the United States. That is why it is important to get it checked during the immigration process to prevent spread.

In addition to making sure I was getting my immigration to-do list sorted out, I also had to contend with new feelings brought on by pregnancy, both happy and stressful ones. This included all day nausea, aka the morning sickness, I had lots and lots of morning sickness. My first instinct was to call my mom and ask for help. She gave me a recipe for a concoction that included turmeric, sage, ginger, and mistletoe. I made it and drank it a couple of times without thinking whether that might be safe during pregnancy since it was all natural and herbal. A few days later, I was talking with one of my best friends, who was pregnant as well, complaining about morning sickness and asking for suggestions that have helped her. She said she would not drink any herbal tea without checking with her doctor. Ding ding, after talking with her, I was terrified to research the topic, and when I did, it confirmed my worst fears. The mistletoe in my nausea drink might cause miscarriage if consumed in large amounts. Many of the other herbs hadn’t been studied in pregnancy at all. I didn’t consume any more of the morning sickness drink and am fortunate that I had a healthy term baby. Lesson learned!

As immigrants, we bring our full heritage with us and try to combine the best of both worlds. Those herbal remedies and recipes are our culture; however, pregnancy is a special and very vulnerable time period. Everybody should be cautious about what we put into our bodies, especially herbal remedies since they are mostly not well studied during pregnancy to show whether they are associated with risks to the baby or not. Even if they are studied, the production and harvesting are not regulated or controlled by the Food and Drug Administration (FDA), or other governmental agencies, and contaminations might happen. Better safe than sorry, right?

Carrying my baby through the immigration process and following my dreams along the way was challenging, but I learned on that road that it is important to question my customs and traditional medications when pregnant. Not everything my mother or grandmother did is safe and effective. Also, I was glad that MotherToBaby was there for me when I was going through the immigration process while pregnant to ask my burning questions about vaccinations and x-rays.

Anyone with questions about herbals, vaccines, TB testing, or any other exposure in pregnancy should know that MotherToBaby is a great resource. Call or chat today to get your individual questions answered by a teratogen information specialist so you can rest assured that you and your baby can have a healthy and well-informed entry into America.


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Download Important Resources Today

The educational tools below offer more information about important exposure topics during pregnancy and breastfeeding. Developed in collaboration with partners who are topic experts, these free resources are available for download and sharing. To view or download infographics in your preferred language, click the corresponding button. For additional details about specific exposures, explore our resource hubs, fact sheets, Baby Blog, and the MotherToBaby Podcast.


Measles Protection Decision Tree

Please see the Measles Protection decision tree that helps determine if you are protected against measles and suggests next steps for getting vaccinated if needed. This information is provided by MotherToBaby in collaboration with the Society for Maternal-Fetal Medicine.

Visit our additional resources on measles and the MMR vaccine. 


Radiation in Pregnancy and Breastfeeding Infographics

Please see the radiation infographics, developed in collaboration with the Health Physics Society, that describe common sources of radiation exposure. The infographics provide a simple, effective way to communicate a complex topic, and offer clarity about whether or not different sources of radiation might be a concern during pregnancy or while breastfeeding.

Visit our additional resources on radiation during pregnancy and breastfeeding.


Vaccines In Pregnancy Infographic

Please see the Vaccines in Pregnancy infographic that describes vaccines that are recommended during pregnancy to protect you and your baby from serious illnesses. The infographic provides information in plain language about the risks of respiratory viruses like flu and COVID-19, the benefits of vaccination, and specific timing for when to get the flu shot, COVID-19 vaccine, RSV vaccine, and Tdap vaccine during pregnancy.

Visit our additional resources on vaccines during pregnancy and breastfeeding.


Medication Safety Tips Sheet

Please see the Medication Safety Tips sheet that provides suggestions to help prevent medication mistakes and what to consider before using supplements during pregnancy and while breastfeeding. This information is provided by MotherToBaby in collaboration with the Arizona Poison and Drug Information Center.


Pesticide Use Safety Tips Sheet

Please see the Pesticide Use Safety Tips sheet that provides suggestions for reducing your exposure to pesticides used indoors and outdoors and tips for safer use of pesticides on the body. This information is provided by MotherToBaby in collaboration with the Arizona Poison and Drug Information Center.



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Working with Pharma on Pregnancy Exposure Registries to Advance Drug Safety Information

MotherToBaby is the nation’s leading authority and most trusted source of evidence-based information on the benefit and risk of medications and other exposures during pregnancy and lactation. Our research division, MotherToBaby Pregnancy Studies, has been working with pharmaceutical companies to fulfill FDA-mandated post-marketing requirements for pregnancy exposure registries for over 20 years. MotherToBaby Pregnancy Studies are Phase 4 clinical trials that are conducted by the non-profit Organization of Teratology Information Specialists (OTIS) and coordinated at UC San Diego’s School of Medicine at the Center for Better Beginnings.

Our experience and excellence at conducting these pregnancy exposure registries is evidenced by the number of our studies listed on the U.S. Food and Drug Administration’s (FDA) pregnancy exposure registry website. We are currently conducting 16 sponsored pregnancy exposure registries that meet post-marketing commitments or requirements for the FDA and/or the European Medicines Agency.

Our Leadership

Christina Chambers, PhD, MPH, a world-renowned perinatal epidemiologist at UC San Diego and expert on the study of medication and vaccine exposures in pregnancy, leads our MotherToBaby Pregnancy Studies. She is a recipient of numerous funded awards from agencies such as the National Institutes of Health (NIH), Centers for Disease Control and Prevention, the FDA, and the National Vaccine Program Office. Her research over the last 20 years has focused on environmental causes of birth defects, including prenatal exposures to medications, and other adverse pregnancy outcomes and childhood disabilities. She has led a number of NIH- and industry-funded complex longitudinal cohort studies involving people who are pregnant and children.

This research has been instrumental in identifying previously unrecognized human teratogens, as well as ruling out substantial risk for other medications and vaccines. This work has not only contributed to product labelling but has also led to changes in clinical practice. You can view Dr. Chambers’ extensive publication history here.

For MotherToBaby Pregnancy Studies, Dr. Chambers has assembled and works closely with an established team of collaborating investigators who have expertise in fields such as dysmorphology, neurodevelopmental toxicology, and biostatistics; each lends their expertise to study design, analysis, and interpretation.

Christina Chambers, PhD, MPH

Our Infrastructure

Our extensive experience in the study of birth defects and other adverse pregnancy outcomes is an invaluable resource for pharmaceutical companies who need to fulfill an FDA post-marketing commitment for a pregnancy exposure registry. We offer an existing study infrastructure on which to build your post-marketing surveillance study, with expertise in protocol development, participant recruitment, pre- and postnatal data collection methodologies, adverse event reporting, and statistical analysis. Our pregnancy exposure registry study team consists of a call center staffed with trained screeners and interviewers, a data management team including medical record abstractors and validators, experienced psychometrists, a team of database programmers and statisticians, and administrative support staff. All of our studies are reviewed and approved by the Institutional Review Board operated by the UC San Diego Human Research Protections Program, which oversees ethical, regulatory, and policy concerns in human subjects research.

Our Design

We can offer you the power of a rigorously designed Phase 4 clinical cohort study that includes exposed, disease control (where applicable), and non-exposed pregnancies. We have an established protocol for marketing and recruitment of eligible pregnancies across the United States and Canada, including a partnership with MotherToBaby’s teratogen information services to receive referrals. We have standardized methods for data collection, review of obstetric and pediatric medical records, and SAE reporting. We also have a team of expert pediatricians who conduct blinded physical examinations of live-born children to evaluate them for major and minor malformations. We also offer you the opportunity to evaluate short- and long-term pediatric outcomes via parent-completed questionnaires and face-to-face standardized developmental testing.

Our study managers provide interim reports to comply with your FDA reporting requirements, and we also establish and coordinate an independent Advisory Board comprised of relevant experts who review and advise on study progress. At study conclusion, we provide you with a final study report for submission to the FDA. Our team also publishes study findings periodically during the course of a study to bring awareness and disseminate findings among the scientific and healthcare community.

Our Clients

We have completed or are in the process of conducting pregnancy exposure registries for the following pharmaceutical companies to fulfill their phase 4 clinical trial post-marketing commitments:

AbbVie

AbbVie is a pharmaceutical company that manufactures adalimumab (Humira®), a tumor necrosis factor (TNF) blocker indicated for treatment of moderately to severely active rheumatoid arthritis and moderately to severely active Crohn’s disease (among other conditions). MotherToBaby Pregnancy Studies completed the Humira® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy. Read our findings.

Amgen

Amgen is the biotechnology company that produces evolocumab (Repatha®), a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated for the treatment of atherosclerotic cardiovascular disease (ASVCD) and familial hypercholesterolemia (FH). Amgen also manufactures etanercept (Enbrel®), a tumor necrosis factor (TNF) blocker indicated for the treatment of: rheumatoid arthritis polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Amgen also acquired from Celgene apremilast (Otezla®), an inhibitor of phosphodiesterase 4 (PDE4) that is indicated for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis. MotherToBaby Pregnancy Studies coordinates the Repatha® & Pregnancy Study, the Enbrel® & Pregnancy Study, and the Otezla® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take these medications during pregnancy.

AstraZeneca

AstraZeneca is a biopharmaceutical business that produces benralizumab (Fasenra™), an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. MotherToBaby Pregnancy Studies conducts the Fasenra™ & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

GSK

GSK is the pharmaceutical manufacturer of mepolizumab (Nucala®), an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated as an add-on maintenance treatment for patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype. MotherToBaby Pregnancy Studies leads the Nucala® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

Leflunomide Consortium

Leflunomide is a pyrimidine synthesis inhibitor belonging to the disease-modifying antirheumatic drug (DMARD) class. It is indicated for the treatment of adult moderate-to-severe rheumatoid arthritis, and was originally marketed under the brand name Arava®. Pharmaceutical companies manufacturing generics of leflunomide participate in a consortium to monitor the effects of this these products when used in pregnancy. MotherToBaby Pregnancy Studies runs the Leflunomide & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

Janssen

Janssen is a Johnson & Johnson pharmaceutical company that produces guselkumab (Tremfya®), an interleukin-23 blocker indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis. Janssen also manufactures ustekinumab (Stelara®), a human interleukin-12 and -23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderate-to-severely active Crohn’s Disease, and moderate-to-severely active ulcerative colitis. MotherToBaby Pregnancy Studies is carrying out the Tremfya® & Pregnancy Study as well as the Stelara® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take these medications during pregnancy.

Pfizer

Pfizer is a biopharmaceutical company that produces the prescription medication tofacitinib (Xeljanz®), a Janus kinase (JAK) inhibitor indicated for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis, or moderately to severely active ulcerative colitis. With BioNTech, Pfizer also developed and produces an mRNA vaccine to prevent COVID-19 infection. MotherToBaby Pregnancy Studies coordinates both the Xeljanz® & Pregnancy Study and the Pfizer-BioNTech COVID-19 Vaccine & Pregnancy Study as an independent research entity to monitor the outcomes of individuals who take Xeljanz® or receive the Pfizer-BioNTech vaccine during pregnancy.

Regeneron

Regeneron is the biotechnology company that makes the prescription medicine dupilumab (Dupixent®), an interleukin-4 receptor alpha antagonist indicated for the treatment of moderate-to-severe atopic dermatitis or as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype. MotherToBaby Pregnancy Studies administers the Dupixent® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

Roche

Roche is the pharmaceutical company that produces the prescription medicine tocilizumab (Actemra®), an interleukin-6 (IL-6) receptor antagonist indicated for treatment of moderately to severely active rheumatoid arthritis, active polyarticular or systemic juvenile idiopathic arthritis, and giant cell arteritis. MotherToBaby Pregnancy Studies directs the Actemra® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

Sanofi

Sanofi is a biopharmaceutical company that produces the prescription medication sarilumab (Kevzara®), a interleukin-6 (IL-6) receptor antagonist indicated for treatment of moderately to severely active rheumatoid arthritis. Sanofi also manufactures teriflunomide (Aubagio®), a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis. MotherToBaby Pregnancy Studies conducts the Kevzara® & Pregnancy Study as well as the Aubagio® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take these medications during pregnancy. Sanofi also manufactures leflunomide (Arava®), a pyrimidine synthesis inhibitor indicated for the treatment of adult moderate-to-severe rheumatoid arthritis. MotherToBaby Pregnancy Studies completed the pregnancy registry for this product; read findings from our Arava® & Pregnancy Study.

Sun Pharma

Sun Pharma is the pharmaceutical company that makes tildrakizumab-asmn (Ilumya™), an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis. MotherToBaby Pregnancy Studies facilitates the Ilumya™ & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.

Takeda

Takeda is the pharmaceutical company that has developed the prescription medication vedolizumab (Entyvio®), an integrin receptor antagonist indicated in adults for the treatment of moderate-to-severely active Crohn’s Disease and moderate-to-severely active ulcerative colitis. MotherToBaby Pregnancy Studies coordinates both the Entyvio® & Pregnancy Study and the Motegrity® & Pregnancy Study as an independent research entity to monitor outcomes of individuals who take these medications during pregnancy.

UCB

UCB is a biopharmaceutical company that manufactures certolizumab pegol (Cimzia®), a tumor necrosis factor (TNF) blocker indicated to reduce the signs and symptoms of Crohn’s disease as well as for the treatment of moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis. MotherToBaby Pregnancy Studies directs the Cimzia® & Pregnancy Study as an independent research entity to monitor the outcomes of females who take this medication during pregnancy.


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