What is a Pregnancy Registry and What Have We Learned from Them?

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When you hear about a “registry” related to someone’s pregnancy the first thing that probably comes to mind is a gift registry for a baby shower. However, there is another important kind of registry that you should know about especially if you plan to have a child and need to take prescription medicines. This type of pregnancy registry is a collection of health information about mothers (and in some cases fathers) and babies who have been exposed to a medicine or vaccine.

As we’ve written before, information about the effects of medicines taken during pregnancy is limited because of challenges in carrying out research in pregnant women. One way to help collect this needed data is to gather information on women and babies who are exposed to medicines, whether intentionally or not, during pregnancy.

Registries are often created and maintained by the company who manufactures the medicine or vaccine. Registries may also be created by independent researchers or by regional or national associations or governments. The U.S. Food and Drug Administration (FDA) is not in charge of pregnancy registries, although they do have the authority to require a manufacturer to create a registry. The FDA does, however, maintain a list of currently active pregnancy registries.

Registries are often created for medicines used to treat chronic diseases or conditions where the risk of stopping drug therapy is considered greater than the risk of continuing it during pregnancy. Examples include medicines used to treat seizures, diabetes, mental illness, or organ transplantation.

Information collected by a pregnancy exposure registry might include demographics of the pregnant woman, the dose and duration of the medicine of interest, details about other medicines taken, and outcomes related to the pregnancy. These outcomes may include fetal growth parameters, infant growth and development, and the result of the pregnancy including whether the baby is born with any birth defects. The outcomes collected in the registry can then be compared to the pregnancy outcomes in the general population or in a similar group of women who have not been exposed to the medicine of interest.

While data obtained from a registry is not considered as robust as that obtained during a well-designed and controlled scientific experiment, it certainly can provide valuable evidence. The findings from pregnancy registries, when considered as one piece of a larger puzzle, may help lead scientists to important answers about how a drug’s characteristics are influenced by pregnancy and how the drug affects both mother and baby. Examples of the type of information that can come from a pregnancy registry are shown in Table 1.

Table 1. Examples of Recently Published Pregnancy Registry Findings

Medicine Studied Disease that Medicine Treats Outcome of Interest Registry Finding First Author of Published Article
Zidovudine HIV infection Infant congenital heart defects The risk that an infant will be born with a heart defect is not significantly different between mothers treated with drug regimens including zidovudine compared with regimens that don’t include zidovudine. Vannappagari
Antihypertensive medicines High blood pressure Small for gestational age (SGA) births No appreciable increase in occurrence of SGA with antihypertensive treatment beyond the slight increase in risk from high blood pressure itself. Fisher
Second generation antipsychotic medicines Various psychiatric illnesses Gestational diabetes in pregnant women No increased risk of gestational diabetes in women taking this class of medicines compared to women with psychiatric illnesses not taking this class of medicines. Panchaud
Adalimumab Rheumatoid arthritis Pregnancy outcome and birth defects No pattern of birth defects or adverse pregnancy outcomes were identified in women treated with adalimumab compared to women with rheumatoid arthritis not exposed to adalimumab or compared to healthy women Burmester

Participating in a pregnancy exposure registry is considered a form of research and it is entirely voluntary. Some registries allow individuals to enroll directly while others require that you enroll through your healthcare provider. Individuals must give consent before enrolling. (In a future blog, I will discuss in more detail what is involved in the informed consent process for research.)

Here are some questions you may want to ask before agreeing to participate in a pregnancy registry:

  • What information about me and my baby will be collected?
  • How will information be collected?
  • How long will I and my baby be followed by the registry?
  • Will any blood tests be required?
  • How will my privacy be protected?

There may not be a direct benefit to you for participating in a pregnancy exposure registry however you and your baby may benefit from being more closely monitored. Also, the information gained from your participation may benefit others in the future.

Deciding whether to continue taking a medicine when becoming a parent is a personal decision that a woman or man must make with the consultation of their doctors and with as much information as can be obtained on the risks and benefits of the treatment options and the risk of the disease if it is not well controlled. Pregnancy registries may help provide some of this important information and the more people who participate in registries the stronger the information will be.

References:

  1. Wyszynski DF. Pregnancy exposure registries: academic opportunities and industry responsibility. Birth Defects Res A Clin Mol Teratol. 2009;85:93-101.
  2. Bromfield EB, Dworetzky BA, Wyszynski DF, Smith CR, Baldwin EJ, Holmes LB. Valproate teratogenicity and epilepsy syndrome. Epilepsia. 2008;49:2122-4.
  3. Holmes LB, Baldwin EJ, Smith CR, Habecker E, Glassman L, Wong SL, Wyszynski DF. Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy. Neurology. 2008;70(22 Pt 2):2152-8.
  4. Vannappagari V, Albano JD, Koram N et al. Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry. European Journal of Obstetrics &Gynecology and Reproductive Biology 2016;197:6-10.
  5. Fisher SC, Van Zutphen AR, Romitti PA et al. Maternal hypertension, antihypertensive medication use, and small for gestational age births in the National Birth Defects Prevention Study, 197-2011. Matern Child Health J 2018;22:237-246.
  6. Panchaud A, Henandez-Diaz S, Freeman MP et al. Use of atypical antipsychotics in pregnancy and maternal gestational diabetes. Journal of Psychiatric Research 2017;95:84-90.
  7. Burmester GR, Landewe R, Genovese MC et al. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis 2017;76:414-417.
Margaret Burke
Dr. Margaret Burke is a board-certified pediatric pharmacotherapy specialist and medical writer. She earned her Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees at The State University of New York at Buffalo School of Pharmacy and Pharmaceutical Sciences and completed a pediatric pharmacy residency and fellowship at The University of Illinois at Chicago. She has worked as a clinical pharmacist caring for neonates and children for more than 20 years. In her spare time she enjoys reading, hiking, and travel adventures with her husband.

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