New Study Seeks Safety Answers For High Cholesterol Treatments During Pregnancy

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Treatments Bring Unique Challenges during Pregnancy with Inherited Form of High Cholesterol, Says MotherToBaby

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I think it’s very valuable to participate in this research so I can feel confident I am taking the best steps to ensure a healthy pregnancy.

Just in time for February’s American Heart Month, MotherToBaby, a service of the international non-profit Organization of Teratology Information Specialists (OTIS) that is dedicated to providing evidence-based information to mothers, health care professionals, and the general public about medications during pregnancy, has launched a new observational study of high cholesterol and the medications used to treat it in pregnancy.

According to the Centers for Disease Control and Prevention (CDC),nearly 1 in 3 American women have higher than optimal low-density lipoprotein (LDL), also known as “bad cholesterol,” levels today. In addition, an estimated 1.3 million Americans have an inherited form of high cholesterol called familial hypercholesterolemia (FH) that may require them to stay on a cholesterol-lowering medication, even while pregnant.

“For women with FH, fixing the problem isn’t as simple as changing their diet and encouraging exercise,” said Maryam Tarsa, MD, a clinical professor and obstetrician at University of California San Diego School of Medicine who specializes in high-risk pregnancies. “Developing babies need cholesterol to form properly, so there is a theoretical concern that cholesterol-lowering medicines could pose pregnancy risk, but for moms-to-be with FH, avoiding cholesterol treatments could pose risks to both mom and baby,” she added. “The bottom line is, we need more information.”

For this reason, MotherToBaby hopes to empower women and their healthcare providers with the information they need to make the best treatment decisions for both mom and baby through its new observational research study. Compared to other research on cholesterol-lowering medications in pregnancy, unique to this study is the follow-up with moms and babies: babies will be eligible to receive a specialized non-invasive pediatric exam with a study doctor, and may be eligible for neurodevelopmental testing when the child is between 4-5 years of age. Participants are not asked to take or alter any medications, do not need to travel, and are not asked to make any changes to their normal routine. Women with and without high cholesterol, particularly FH, who are pregnant and who reside in the U.S. or Canada may be eligible to participate, and may call 877.311.8972 or visit MotherToBaby.org for more information.

“I think it’s very valuable to participate in this research so I can feel confident I am taking the best steps to ensure a healthy pregnancy,” said one mother-to-be who recently enrolled in MotherToBaby’s research program. “The information I can provide will lead to improved knowledge of best practices during pregnancy and ultimately better care for pregnant women.”

Health care providers as well as potential participants can also email questions about the study to MotherToBaby(at)ucsd(dot)edu. MotherToBaby is recruiting 375 women for participation in the study.

More About MotherToBaby
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. MotherToBaby has been able to embark on new outreach efforts to reach underserved populations and launch new communication technologies through a cooperative agreement with the U.S. Health Resources and Services Administration, as well as through generous donations made by the public. To learn more about MotherToBaby, the ways to contact its network of experts, or how to support its services, please visit http://www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez(at)MotherToBaby(dot)org. Interviews in Spanish can also be arranged.

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