World-Renowned UC San Diego Epidemiologist Leads Groundbreaking Study

SAN DIEGO, CA – Recruitment is underway for a groundbreaking new study on the treatment of lupus during pregnancy.  The observational research, led by world-renowned UC San Diego epidemiologist Christina Chambers, PhD, MPH, is the first of its kind for the non-profit MotherToBaby, a CDC-recommended organization that provides evidence-based information on medications, diseases, vaccines, herbal supplements and more during pregnancy and breastfeeding. 

The study will recruit 400 pregnant people over a five-year period to evaluate use of the lupus drug Benlysta® (belimumab) in pregnancy. Benlysta® is used to treat the most common type of lupus, systemic lupus erythematosus (SLE), as well as lupus nephritis. Currently, there is limited information on the drug’s use in pregnancy.

The study will be MotherToBaby’s first to focus on a treatment specifically for lupus, and participants will be enrolled into the MotherToBaby Pregnancy Studies research program. Chambers, who is the lead investigator for MotherToBaby Pregnancy Studies, Co-Director of the Center for Better Beginnings, and Chief of the Environmental Science and Health Division in the UC San Diego Department of Pediatrics, noted that, “lupus can raise the risk of pregnancy complications, so it’s important for both the mom and her developing baby that this condition be well-managed during pregnancy. So, when treatments for lupus like belimumab are available, we want to do our best to gather information about those pregnancies where this medication has been used.”

The study is enrolling pregnant and recently pregnant people with exposure to Benlysta® and will provide critical information on the use of this medication during pregnancy. Participants will not be asked to change any part of their health care routine, including medications, nor will they be asked to travel.

More about MotherToBaby Pregnancy Studies

MotherToBaby Pregnancy Studies are conducted by the non-profit Organization of Teratology Information Specialists (OTIS) and coordinated at the Center for Better Beginnings at UC San Diego. OTIS is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and include experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies.

MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC). MotherToBaby is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,000,000 with zero percentage financed with non-governmental sources. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. To learn more about MotherToBaby and OTIS, please visit MotherToBaby.org.

Media Contact: Nicole Chavez, nchavez@mothertobaby.org, 619-368-3259

We Can Help You and Your Pregnant and Lactating Patients Make Informed Decisions

MotherToBaby supports midwives as they care for their patients during preconception planning, pregnancy, and delivery. People who are pregnant often have a litany of questions about how best to ensure a healthy pregnancy and healthy baby – and some of those questions may center on how a person’s exposures could impact their developing baby during pregnancy or while breastfeeding. Examples of such exposures could include but are not limited to medications that a person may need to take, foods or beverages they consume, substances they use, infections they may contract, or vaccines they may need to receive. Exposures are different for every person, and the bottom line is we all want what is healthy for both parent and baby.

We’re the experts on evaluating the effects of exposures during pregnancy and breastfeeding. Our resources are no-cost and patient-friendly, and will help you understand the benefit or risk of an exposure for the person who is pregnant and their baby. No matter if your patient has a preexisting illness, a medical problem that requires diagnostics or medication treatment, or has questions about substance use, we are here to provide you with evidence-based information on exposures during pregnancy and lactation.

Midwives are ideally positioned to prevent or limit toxic exposure in [people who are pregnant], fetuses, and infants.

— American College of Nurse Midwives: The Effect of Environmental Toxins on Reproductive and Developmental Health, 2015

Explore how we can help you and your pregnant and breastfeeding patients by providing no-cost exposure risk assessments, patient education materials, observational studies to monitor pregnancy outcomes, and more.

By Lori Wolfe, CGC, MotherToBaby North Texas

Nicole called me in tears. She had been trying to become pregnant for the past nine months and was not having any luck. She asked if it could be due to being overweight. As I talked with Nicole, I found out she is about 100 pounds over a healthy weight for her height. As a MotherToBaby specialist, I often talk with women who are trying to become pregnant. It just so happened this question came along as I was reviewing tips for January’s Birth Defects Prevention Month. Tip #4 is: Before you get pregnant, try to reach a healthy weight.

I explained to Nicole that studies have shown that women who are overweight can have a number of different problems trying to become pregnant, but she shouldn’t worry. Many of the problems outlined below can be reversed when healthy eating and exercise are incorporated into her routine. Some of the issues which can result from being overweight while trying to conceive include:

1. An increased chance of having irregular or absent periods, making it difficult to conceive
2. Producing too much estrogen, which can also make it harder to get pregnant
3. An increased chance of having complications during fertility treatments
4. Having polycystic ovary syndrome , a hormonal disorder that is a major contributor to infertility in women of child bearing age

Once they get pregnant, women who are overweight or obese are at a higher risk for the following complications during pregnancy:

• Miscarriage
• Heart disease
• Increased chance for a birth defect in the baby
• Gestational diabetes
• High blood pressure and preeclampsia (a dangerous kind of high blood pressure that can happen during or right after pregnancy))
• Cesarean birth

After discussing all of this with Nicole, her next question to me was what can she do to reduce these possible risks? Fortunately, most women with overweight can expect to have a healthy pregnancy. I explained to Nicole that it is best to talk with her doctor and try to lose weight before becoming pregnant. Losing weight once you are pregnant is not advised. Start now to eat a healthy diet and exercise regularly before pregnancy, and keep this up once you become pregnant.

Healthy eating includes folic acid
Another important Birth Defects Prevention Month tip is Tip #1: Be sure to take 400 micrograms (mcg) of folic acid every day.

We all need folic acid every day in our bodies to help make new cells. Folic acid is a synthetic form of Vitamin B9, also known as folate. It is very important to take enough folic acid just before and during pregnancy. Many studies have shown that taking 400 mcg of folic acid before and early in pregnancy every day reduces the chance that a baby will have serious birth defects of the spine and brain, called neural tube defects (NTDs). This is even more important in women who are overweight as their body requires more folic acid.

Nicole was relieved to hear that her weight didn’t have to be an obstacle and that there were things she could do to increase her chance of becoming pregnant and having a healthy baby. Losing weight, eating healthy foods and daily exercise can increase her chances of becoming pregnant and can decrease her chances of miscarriage, birth defects and other pregnancy problems. She said she will call her health care provider right away to schedule an appointment to talk about everything and was excited that the future looked brighter to one day become a mom!

Lori Wolfe, CGC, is a board certified Genetic Counselor and the Director of MotherToBaby’s North Texas affiliate. MotherToBaby aims to educate women about medications and more during pregnancy and breastfeeding. Along with answering women’s and health professionals’ questions regarding exposures during pregnancy/breastfeeding via MotherToBaby’s toll-free number, text line and by email, Wolfe also teaches at the University of North Texas, provides educational talks regarding pregnancy health in community clinics and high schools.

About MotherToBaby
MotherToBaby is a service of the Organization of Teratology Information Specialists (OTIS), suggested resources by many agencies including the Centers for Disease Control and Prevention (CDC). If you have questions about exposures during pregnancy and breastfeeding, please call MotherToBaby toll-FREE at 866-626-6847 or try out MotherToBaby’s new text information service by texting questions to (855) 999-3525. You can also visit MotherToBaby.org to browse a library of fact sheets about dozens of viruses, medications, vaccines, alcohol, diseases, or other exposures during pregnancy and breastfeeding or connect with all of our resources by downloading the new MotherToBaby free app, available on Android and iOS markets.

By Mara Gaudette, MS, CGC, Teratogen Information Specialist, MotherToBaby California

The chat message came through promptly at my morning start time. The words and exclamation marks clearly highlighted worry. “Just found out I’m pregnant! Taking a statin medication to lower cholesterol since 6th grade! Talked to my doctor and stopped taking it yesterday. But what damage have I already done? I know it’s a class X drug! Need info – please help!” Mae agreed to a phone call, and I logged off from our MotherToBaby live chat service and phoned Mae.

First, you may wonder why someone would be on a cholesterol-lowering medication since late elementary or middle school. Isn’t that extreme? Actually no- in Mae’s case she has an inherited condition called familial hypercholesterolemia – or “FH” for short. This is a condition that occurs in about 1 in every 250 persons but is underdiagnosed and therefore undertreated. A simple blood test checking cholesterol levels and a review of your family history (such as checking for heart attacks at younger ages) can help determine if you have FH. Much less common, a more severe form of FH, inherited from both parents, can occur.

To back up a bit, cholesterol is that fatty substance in our bodies that is needed in some amount, but too much cholesterol increases our chance for early heart disease. The lifestyle changes that are recommended to all of us, such as exercising regularly, avoiding smoking, and eating a healthy diet are also part of the treatment plan for FH (and Mae had been working hard to follow these guidelines). But, cholesterol lowering medications are still often a needed part of treatment because lifestyle alone won’t lower cholesterol levels enough in persons with FH. For some with FH, statin medications might be prescribed starting at 8-10 years old.

But what about the “category X” classification Mae mentioned-does this mean that statin medications are absolutely proven to increase birth defects? Fortunately, for Mae the answer is a resounding “no!” Many persons are not aware that the FDA decided in 2014 to phase out their letter category rating system. While an easy system to use, it was not a reliable system to predict pregnancy risk (see our January 2015 blog for more information).

So why were statins assigned that old category X? Well, the developing baby needs cholesterol to form properly so there is a theoretical concern that cholesterol-lowering medications could pose a pregnancy risk. Also, for many persons, particularly those without FH, stopping a cholesterol-lowering medication in the short term of a pregnancy is thought unlikely to significantly increase their heart disease risks. However, for some persons, avoiding all cholesterol treatments might pose concerns for both the pregnant woman and baby. So, if you have FH, talking with your cardiologist and obstetrician about a cholesterol treatment plan is important when planning a pregnancy or when you learn of your pregnancy.

Most studies with the class of medications called “statins” have not found an increase in birth defects with accidental use early in pregnancy. This should provide some reassurance to pregnant women who were taking statins before they realized they were pregnant, like Mae. (For more info, see our fact sheet on Statins in pregnancy.)

“I feel a little better. But, I wish there were more pregnancies that were studied. We need more info about medications we might have to take during pregnancy,” Mae said. At MotherToBaby, we completely agree! And I appreciated her lead to bring up our optional follow-up program. I let Mae know that in addition to providing information, we have a study team that follows pregnancy outcomes. This will allow us to provide more information to worried parents and their healthcare providers. So, if you find yourself like Mae drawn to the importance of this information and wondering how you can contribute, call 877-311-8972, email mothertobaby@ucsd.edu or you can volunteer for a study through our website. There is no cost to participate and pregnant women are never asked to take a medication.

Mara Gaudette is a genetic counselor and received her Masters Degree from Northwestern University. Drawn to the satisfaction of providing immediate reassurance to worried women, she began educating the public about teratogens at MotherToBaby’s Illinois affiliate more than a decade ago. Today, she not only continues to counsel for MotherToBaby via phone, but also on live chat and email as part of MotherToBaby California’s team of experts.

MotherToBaby is a service of OTIS, a suggested resource by many agencies including the Centers for Disease Control and Prevention (CDC). If you have questions about exposures like cholesterol medication, please call MotherToBaby toll-FREE at 866-626-6847 or try out MotherToBaby’s text information service by texting questions to (855) 999-3525. You can also visit MotherToBaby.org to browse a library of fact sheets about dozens of viruses, medications, vaccines, alcohol, diseases, or other exposures during pregnancy and breastfeeding.

Did you know that 70% of pregnant women take at least one prescribed medication? And that 90% take any medication during pregnancy? How do you know if it is safe for a pregnant woman to take these medicines?

MotherToBaby Teratogen Information Specialists (TIS) are experts at answering questions about any possible increased risk of taking an over-the-counter (OTC) or prescribed medication, as well as any other exposures! A teratogen is something that can increase the risk for birth defects to the developing baby, and other problems such as a smaller baby or early delivery, when exposure occurs during pregnancy. Special intensive training is required to become a TIS, before we are able to answer the questions of healthcare providers, pregnant and lactating women, their relatives and partners, prospective adoptive parents, and the public. We get calls from people of all ages, teens up to older adults, even prospective grandparents. Teratogen specialists learn how to investigate the question, summarize the data, and then communicate it in a way that is easily understood. Every contact is a little different because each scenario is different, but that makes each day endlessly fascinating for those at MotherToBaby who respond to your inquires.

This work is different than the work of other healthcare providers such as a genetic counselor, midwife or obstetrician – we don’t generally delve into family history, and we don’t make direct recommendations. We try to be reassuring as we give you the most up-to-date exposure information. We consider the potential effects of taking AND not taking a medication, herbal supplement, or OTC drug. There are important considerations when someone is planning a pregnancy, facing a newly discovered pregnancy or an unanticipated pregnancy, dealing with worsening mental or physical health conditions, or with the sudden diagnosis of a birth defect or pregnancy loss.

We answer questions from prospective adoptive parents who may only have 36 hours to decide if they will accept a baby whose biological mom used heroin, methamphetamine or alcohol in pregnancy. We listen to pregnant callers worried about the substantial alcohol they drank or the marijuana they used before getting a positive pregnancy test. We also answer questions from people worried about Zika virus exposure on their honeymoons. And common questions these days involve the COVID-19 virus and the COVID vaccines and booster shoots given at any time in pregnancy or while breastfeeding.                                                  

Teratogen specialists also get calls about the potential consequences of pain medications for those who are pregnant and facing surgery such as a pre-op visit for a herniated disc – and are in excruciating pain. We have numerous conversations with lactating women who were advised to “pump and dump” after dental work or general anesthesia, or CT scans and we are able to discuss why this dated practice is usually unnecessary. Some women call repeatedly due to anxiety or simply because our TIS team has reliable expertise. We also answer breastfeeding questions about COVID-19 and the vaccines, prescriptions and OTC medications, or how much of a drug gets into breastmilk.  And we get questions from pregnant and postpartum individuals who are trying to avoid using inhalers or taking their anxiety/nausea/ADHD medications. We share the research and reassure them that some health conditions need to be treated with medications because it’s best for mom and baby. Some conversations are more sensitive – such as women with a history of multiple miscarriages, IVF, or other high-risk pregnancies who are trying to make only the best choices in a high-stakes stressful time. Sometimes there are tears, and that’s OK.

Often, we talk about the benefits to the individual of taking/using the medication or other product, versus any possible risks to the pregnancy or the baby. We tell them to consider the long view, that as a parent, you will be making “risk vs. benefit” decisions for nearly the next two decades for the child growing inside you. So, it’s important for you to make a choice now that gives you a good quality of life, and also to consider every aspect of the consequences for you both mentally and physically. In addition, it is in the important input of your partner and your healthcare providers.

It is a privilege to be part of the lives of all those who come to MotherToBaby for information. We are sensitive to different cultures, backgrounds, sexual orientation, and gender identification. We have 12 affiliate offices in the US and one in Canada. We provide information by phone, text, email, and live chat, and because we work across three times zones, we can respond quickly!

Affiliate offices are based in universities, academic medical centers, or health departments. Our multi-disciplinary team of Teratogen Information Specialists includes genetic counselors, nurses, doctors, and others with a master’s degree or Master of Public Health specifically. We also provide services in Spanish. We meet at least annually for training plus more often within our own institutions to discuss new publications and developments in the field.

Please spread the word. We welcome your inquiries!