Published online this week in The Journal of Allergy and Clinical Immunology, the action plan describes the proceedings from a workshop conducted in November 2019 and supported by the National Heart, Lung, and Blood Institute and the Office of Research on Women’s Health in the Office of the Director of the National Institutes of Health and the U.S. Food and Drug Administration Office of Women’s Health. The workshop assembled key stakeholders who were tasked with prioritizing, strategizing and mobilizing action steps on gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The overarching goal of the workshop was to identify approaches that could be applied broadly to fill gaps in data about the safety of all medications and vaccines in pregnancy and lactation.

As a result of the workshop, a multi-stakeholder consortium on asthma medications in pregnancy and lactation has been developed. In order to address the evidence gaps and aid in populating medication labels with data that health providers can use to inform clinical decision making, the consortium developed a plan to systematically obtain necessary data in the most efficient and timely manner.  The consortium also recommended the development of guidelines for the evaluation and management of asthma during pregnancy and lactation that adhere to the standards developed by the National Academy of Medicine, which would not only offer recommendations for patients, caregivers, and health providers at the point-of-care but also highlight specific evidence gaps that warrant further research. According to Chambers, “the need for high quality information regarding medication and vaccine safety in pregnancy and lactation is great – implementation of the recommendations stemming from this workshop will be a major step forward in addressing this health disparity.”

In partnership with VAMPSS, MotherToBaby conducts observational pregnancy studies to evaluate the safety of medications used to treat asthma and other health conditions. MotherToBaby Pregnancy Studies accept both healthcare provider referrals as well as patient self-referrals. To learn more, visit: MotherToBaby.org/Studies.

Read the Abstract

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LA JOLLA, CA –A new study conducted by birth defects research experts from the non-profit Organization of Teratology Information Specialists (OTIS) launches to examine the short and long-term effects of the novel COVID-19 virus in pregnancy and breastfeeding. The observational study will consist of phone calls over the course of volunteers’ pregnancies and post-delivery, and/or breastmilk samples, as well as a release of medical records related to the pregnancy and the infant’s development.

OTIS is the scientific non-profit society that provides the no-cost MotherToBaby information service and enrolls women through the MotherToBaby Pregnancy Studies.

“Women and their health care providers need answers as quickly as possible regarding the effects of COVID-19 during pregnancy and while breastfeeding,” said the Principal Investigator, Christina Chambers, PhD, MPH, OTIS/MotherToBaby president and professor of pediatrics at UC San Diego (pictured right). “We know that pregnant and breastfeeding moms are contracting COVID-19, but the fact of the matter is that we know very little about its short and long-term effects on a developing baby,” she added. “We hope pregnant women see the importance in helping the world understand this novel virus and consider volunteering for the study.”

The study is open to pregnant and breastfeeding women in the United States and Canada with known or suspected COVID-19 infection. The MotherToBaby Pregnancy Studies Research Center is located at the University of California San Diego.

Pregnant women and breastfeeding mothers can enroll in the study at the following link https://mothertobaby.org/join-study/ or by calling MotherToBaby Pregnancy Studies at (877) 311-8972. Learn more about the ongoing observational study at https://mothertobaby.org/ongoing-study/coronavirus-covid-19/.

Health care providers can refer pregnant and breastfeeding patients with known or suspected COVID-19 infection at the following link https://mothertobaby.org/healthcare-professional-referral-form/ or by calling MotherToBaby Pregnancy Studies at (877) 311-8972.

More about OTIS and MotherToBaby

The Organization of Teratology Information Specialists (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 includes 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). To learn more about ongoing MotherToBaby Pregnancy Studies, call (877) 311-8972, email MotherToBaby@ucsd.edu or visit www.MotherToBaby.org.

The study launched March 23, 2020. Interviews with Christina Chambers, PhD, MPH are now being scheduled. Interested media, please call 619-368-3259 or email nchavez@mothertobaby.org.

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LA JOLLA, CA –A new study conducted by birth defects experts from the Organization of Teratology Information Specialists (OTIS) suggests adalimumab use in pregnancy was not associated with an increased risk for adverse outcomes examined, such as major structural birth defects, spontaneous abortion and preterm delivery. The findings were published today in the Public Library of Science (PLOS) One Journal.

The prospective research study conducted by OTIS examined 602 pregnancies that occurred between 2004 – 2016 in women across the U.S. and Canada. Researchers enrolled pregnant women into the observational cohort study who had or had not taken adalimumab for their autoimmune disease, as well as generally healthy pregnant women for comparison. OTIS is the scientific non-profit society that provides the no-cost MotherToBaby information service and enrolls women through the MotherToBaby Pregnancy Studies Research Center at the University of California San Diego. Financial support for the adalimumab study was provided by AbbVie.

“Many women hoping to start a family rely on adalimumab to control symptoms related to crippling autoimmune diseases such as rheumatoid arthritis or Crohn’s Disease,” said lead study author Christina Chambers, PhD, MPH, OTIS/MotherToBaby president and professor of pediatrics at the University of California, San Diego. “The fact that this study showed no increased risk in adverse birth outcomes with the use of adalimumab in pregnancy is important since not a lot of research was previously available on this particular medication.”

The study also found that regardless of whether they took adalimumab or not, pregnant women with rheumatoid arthritis or Crohn’s Disease were at an increased risk of preterm birth (delivery before 37 weeks of pregnancy).

“Studies on medication use in general are lacking when it comes to understanding their effects on pregnancy, making it difficult for pregnant women and their healthcare providers to make informed decisions,” said Dr. Chambers. “We are proud to add valuable information to the literature and encourage more pregnant women to consider volunteering for critical observational studies.”

For more information on all of the current MotherToBaby Pregnancy Studies, please visit https://mothertobaby.org/pregnancy-studies/.

More about OTIS and MotherToBaby

The Organization of Teratology Information Specialists (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 includes 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). To learn more about ongoing MotherToBaby Pregnancy Studies, call (877) 311-8972, email MotherToBaby@ucsd.edu or visit www.MotherToBaby.org.

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

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