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.
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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For more than 40 years, our team has been providing information on exposures in pregnancy and breastfeeding.
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