by the MotherToBaby Public Affairs Committee

UPDATED STATEMENT AS OF FEBRUARY 4, 2016

MotherToBaby Experts Offer Evidence-Based Information about Zika Virus during Pregnancy
On February 1, 2016 the World Health Organization (WHO) declared “A Global Public Health Emergency” over the Zika virus, due to its suspected ability to cause microcephaly in unborn babies (1). The Centers for Disease Control and Prevention (CDC) “developed interim guidelines for healthcare providers in the United States caring for women during a Zika virus outbreak.” (2) These guidelines include recommendations for pregnant women considering travel to an area with Zika virus transmission and recommendations for disease testing, ultrasound testing, and management of pregnant women returning to the United States after traveling to areas where the virus is being transmitted. Since some infected, pregnant women will not show symptoms, providers may consider additional ultrasound testing. The CDC states that, in addition to the routine ultrasound testing at 18-20 weeks of pregnancy, “additional ultrasounds might provide an opportunity to identify findings consistent with fetal Zika virus infection and offer pregnant women the option of amniocentesis to test for Zika virus RNA.” (3) These CDC guidelines will be updated as more information becomes available.
MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS), is suggested as a resource by many agencies including the CDC and the Food and Drug Administration’s (FDA) Office of Women’s Health. MotherToBaby offers evidence-based information about exposures, such as the Zika virus, during pregnancy and breastfeeding through its toll-free phone line (866-626-6847), text message (855-999-3525) and digitally via email and live chat on www.MotherToBaby.org.

We can cover topics such as:
• Mode of transmission
• Regions where it has been identified
• Symptoms of infection
• Effects of the infection and symptoms on the pregnancy
• Effects of treatment of the infection and symptoms on the pregnancy
• Prevention of infection
• Central nervous system (CNS) malformations
• Information on types of testing depending on when the infection occurred

References:
1) http://www.npr.org/sections/thetwo-way/2016/02/01/465163095

2) http://www.cdc.gov/mmwr/volumes/65/wr/mm6502e1.htm

3) http://www.cdc.gov/zika/hc-providers/qa-pregnant-women.html

OFFICIAL STATEMENT AS OF JANUARY 13, 2016

Recently, there have been reports of the Zika virus cases and its possible effect on a pregnancy. While information is currently limited, there are some things we know:

Zika virus was first identified in Africa in 1947. In 2013, there were outbreaks in islands in the Pacific, and now outbreaks are being reported in many Central and South American counties. Isolated cases have been also reported in Puerto Rico and Texas in the last few weeks.

Zika virus is spread by mosquito bites. Symptoms of the Zika virus include fever, headache, joint and/or muscle pain, conjunctivitis (“pinkeye”) and sometimes a rash.

There have been reports of microcephaly (small head and brain) in the babies of pregnant women who were infected with the Zika virus during pregnancy. Research is ongoing to determine if Zika virus is the cause of microcephaly in infants whose mothers were infected with the virus during pregnancy and if the stage of pregnancy plays a role.

There is no vaccine or cure for the Zika virus. Symptoms are treated as they arise (such as using acetaminophen to treat fever and/or headaches). Prevention is the best approach. That includes using bug repellent (including formulas that contain DEET- https://mothertobaby.org/fact-sheets/deet-nn-ethyl-m-toluamide-pregnancy/), wearing protective clothing, and removing standing water where mosquitoes live. For more information, please visit http://www.cdc.gov/zika/prevention/index.html.

If you have questions or concerns about the Zika virus, please contact a bilingual (English/Spanish) MotherToBaby expert by calling 1-866-626-6847 or texting questions to 855-999-3525 (standard text messaging rates may apply). You can also chat live or send an email through www.MotherToBaby.org.

MotherToBaby is a suggested resource by many agencies including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration’s (FDA) Office of Women’s Health. More than 100,000 women and their health care providers seek information about birth defects prevention from MotherToBaby every year.

Thank you for your interest in working together. MotherToBaby offers various ways to collaborate with and highlight our partner organizations. Please complete the form for consideration of partnership opportunities with MotherToBaby. Not all options are guaranteed, and final decisions will be at MotherToBaby’s discretion. After completing this form, you will be contacted by the MotherToBaby Strategic Partnerships.

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.

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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. 

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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.

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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.

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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.

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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

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:

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Contact Us to Learn More

Fill out the form below to learn how we can help your company fulfill an FDA post-marketing commitment.

Emily called MotherToBaby and confided, “My husband and I are thinking about getting pregnant…I am so excited but scared, too. I am wondering what I can do to make it more likely we will have a healthy pregnancy and baby.”   

I assured Emily that we love it when people call ahead of their pregnancy and ask these questions. Preconception health is a topic that does not receive as much attention as it deserves, and it is important for both Emily and her husband. Good preconception health care can impact fertility and make it easier to conceive, and also helps to improve pregnancy outcomes and the health of the baby.   

Here is a preconception prep guide– because if you are ready to have a baby, you want to take steps now to keep you and your baby as healthy as possible:

• Make a pre-conception checkup appointment: Begin by making an appointment about three months in advance with your obstetrical care provider. At that appointment you can confirm you are in good health. If you have any chronic conditions such as high blood pressure, thyroid disease, depression or diabetes you and your provider can make sure the condition is being managed effectively and confirm that any prescription or over-the-counter medications you are taking can be continued in the pregnancy. If you have a question about medications during pregnancy, MotherToBaby can help by providing you with information to bring to your appointment.
• Begin taking a prenatal vitamin: If you are not already taking a vitamin with folic acid this is a great time to start. The Centers for Disease Control and Prevention (CDC) recommend that all women who can become pregnant take a vitamin containing 400 micrograms of folic acid; this helps reduce the chances for certain birth defects such as spina bifida (when the spinal cord does not form properly).
• Review your vaccine status: During your preconception checkup, make sure that you are up to date on vaccinations such as the MMR (measles, mumps, rubella), Tdap (tetanus, diphtheria, whooping cough), influenza, and COVID. Planning ahead makes it more likely you will not get ill during pregnancy and helps protect the baby from getting infections from parents after birth.
• Get your body fit for pregnancy: Get regular exercise and consider whether you and your partner are at your preferred weight. If not, make plans to remedy that prior to attempting to get pregnant. You can also learn more about a healthy diet and nutrition. This is something that may improve fertility in both parents and lay the groundwork for a healthy pregnancy.
• Eliminate harmful exposures: It goes without saying that this is a great time to make lifestyle changes such as reducing use of alcohol, tobacco, and recreational drugs.  Addressing stress and mental health concerns up front can improve fertility, make the whole pregnancy experience better, and prepare you for the excitement and hard work of parenthood.
• Evaluate your home and work environment: If you and your partner are exposed to toxic substances like lead in your work or home environment, working to reduce those exposures is very effective when done ahead of the pregnancy.

MotherToBaby has many resources for Emily and her husband – and you!  We have fact sheets on medications, herbal agents and supplements, diabetes and other health conditions, illnesses and vaccinations, occupations such as veterinarian and dental, exercise, paternal exposures, and cosmetics (sunscreen, skin creams, nail polish, hair dye). There are also useful blogs and podcasts, and whole web pages on various conditions, and if you have questions, our information specialists are here to help.