Our New Studies Offer First COVID-19 in Pregnancy & Breastfeeding InvestigationsMarch 27, 2020
Researchers at the Center for Better Beginnings have launched two new studies examining the effects of the novel coronavirus (COVID-19) in pregnancy and breastfeeding.
An observational study coordinated by our MotherToBaby Pregnancy Studies is currently enrolling women with known or suspected COVID-19 infection during a current or recent pregnancy or within 30 days of a woman’s last menstrual period before conception.
“To date, there are only a few case reports of pregnancy outcomes following maternal infection with this new virus,” said our Co-Director Christina Chambers, PhD, MPH, lead investigator of MotherToBaby Pregnancy Studies, professor in the Department of Pediatrics at UC San Diego and current president of the Organization of Teratology Information Specialists (OTIS), the non-profit organization comprised of birth defects experts and which provides the no-cost MotherToBaby information service. “However, prior research on respiratory infections, such as seasonal influenza, has indicated that pregnant women in general are at higher risk than non-pregnant women for complications from the infection, which in turn can lead to more common pregnancy complications, such as preterm delivery. In addition, a high fever early in pregnancy may pose a risk for the developing fetus.”
The study will recruit pregnant women who reside anywhere in the United States or Canada. Mothers will be interviewed by telephone over the course of their pregnancy and postpartum period and will be asked to release relevant medical records from their and their baby’s health care providers. This information will be used to assess the course of pregnancy and outcomes for both mother and infant. This work will be coordinated with other efforts being initiated throughout the U.S. and other countries.
In addition, our Mommy’s Milk: Human Milk Biorepository is launching a study looking at breastfeeding women with known or suspected COVID-19 infection. Using a common protocol developed in coordination with UC San Diego’s MOMI CORE, mothers will be interviewed by phone and will be asked to provide some biological samples from themselves and their infant, including a sample of breast milk. Information will also be gathered on the infant’s growth and developmental outcomes.
“Women and their health care providers need answers as quickly as possible regarding the effects of COVID-19 during pregnancy and while breastfeeding,” said Chambers. “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.”
If you would like to join our important new studies, please contact us for more information.
MotherToBaby California Celebrates its 40th AnniversaryOctober 24, 2019
The very first MotherToBaby information service is celebrating its 40th year of service at the UC San Diego Center for Better Beginnings this October! Program Founder and current Medical Director Dr. Ken Lyons Jones recalled that when he joined UC San Diego in 1974 as a new pediatrician, he was fresh off the publication of his seminal paper that first described Fetal Alcohol Syndrome, a condition that results in brain damage and growth problems in a child when alcohol is consumed during pregnancy. As a specialist focused on identifying and treating children with birth defects, Dr. Jones noticed that he started receiving an increasing number of calls from his healthcare colleagues and from women in the local community who wanted to know about the effects of different environmental exposures (like medications a mom was taking) during pregnancy and while breastfeeding.
“What we’d do was say, ‘We don’t know, but we could find out!’ Then we’d race over to the library and look up everything that we could find on that drug. We’d find all kinds of information about the effects of the medication on a rat, guinea pig or mouse – and we would call back the woman and tell her everything that we found out about the effects on that rat, guinea pig and mouse. And she’d say ‘that is really interesting – but what about me?’ And we’d say, unfortunately there’s no information about how it affects human health or developing fetus,” said Dr. Jones while addressing the audience at our October 3rd celebration. The volume of calls he received suggested to Dr. Jones a dire need in the community, so in 1979 Dr. Jones founded the first “teratogen information service” – a service dedicated to providing up-to-date, evidence-based information about environmental exposures during pregnancy and while breastfeeding. Initially called the San Diego County Teratogen Registry, the program soon expanded organically – and by necessity – into a parallel research program to collect pregnancy information from women with select exposures so that critical information gaps on medication safety could be filled.
Over the years, the name of the service changed a few times. In 1989, it became the California Teratogen Information Service (CTIS) and Clinical Research Program. Later, the program became an affiliate of the non-profit Organization of Teratology Information Specialists (OTIS), and when OTIS changed the name of the information service to MotherToBaby in 2013, MotherToBaby California was born! Similarly, the research program has evolved over time and is now known as MotherToBaby Pregnancy Studies, one of the largest pregnancy registries on medicines and vaccines in North America.
As the first-of-its-kind, MotherToBaby California has been used as a model nationally and worldwide for the development of other teratogen information services. Importantly, in its 40 year history the program has always been available at no-cost to the public. It has been supported by continuous funding since 1981 from the California Department of Education, and since 2014 has also received sub-awardee funding from the U.S. Health Resources & Services Administration.
Earlier this month, moms, community partners, and current and former program staff came together to celebrate the monumental achievements of the program. The value of the program, as one mom shared, was that “While there were a lot of unknowns about my medications, I at least felt like I had some information and I could make an educated decision – not one based on fear.” Please join us in celebrating the origins and accomplishments of MotherToBaby California and our continued effort to promote the health of moms and babies and reduce the risk of preventable birth defects!
Center Researchers Find Adalimumab Exposure in Pregnancy Does Not Increase Birth Defects RiskOctober 18, 2019
Adalimumab (sold under the trade name Humira®) is a medication used to treat a number of autoimmune diseases, including rheumatoid arthritis and Crohn’s Disease. But what effects might it have if it is taken during pregnancy? Our new study, which was published today in the journal Public Library of Science (PLOS) One, examined this very question.
What did we do? As part of our MotherToBaby Pregnancy Studies, we recruited 602 pregnant women across the United States and Canada between 2004-2016. This included women who had or had not taken adalimumab for their autoimmune disease, as well as generally healthy pregnant women for comparison. Women were followed until they delivered their babies, and their babies were followed up to 1 year of age. We collected information by interviewing moms, examining medical records, and conducting a specialized exam with the babies. Funding for the study was provided by AbbVie.
What did we find? We found that the use of adalimumab in pregnancy is not associated with an increased risk for adverse outcomes, such as major structural birth defects, spontaneous abortion, and preterm delivery. We also found that regardless of whether they took adalimumab, pregnant women with rheumatoid arthritis or Crohn’s Disease were at an increased risk of delivering their baby pre-term (before 37 weeks of pregnancy).
So what’s the take-away? The lead investigator on this study and our Center co-director Dr. Tina Chambers, PhD, MPH, said it best: “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. 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.”
She added that, “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.”
Center Receives Funding for Planning Phase of HEALthy Brain and Child Development StudyOctober 17, 2019
The use of opioids during pregnancy has been linked to a number of adverse outcomes, including serious birth defects, premature birth, miscarriage or stillbirth, and neonatal opioid withdrawal syndrome (NOWS), where a newborn infant experiences opioid withdrawal after exposure in the womb. What remains largely unknown is whether and how prenatal exposure to opioids impacts a child’s brain and development.
To help us move toward answering these questions, Center for Better Beginnings co-director Christina Chambers, PhD, MPH, was recently awarded a grant from the National Institute of Drug Abuse. Our team at UC San Diego, along with teams at 27 other sites across the US, will lead the development of a nationwide study called the HEALthy Brain and Child Development (HEALthy BCD) Study. Underneath this planning grant, Dr. Chambers and the multidisciplinary team that she has assembled at UC San Diego – including researchers in psychiatry, obstetrics/maternal fetal medicine, neonatology, clinical psychology, ethics, bioengineering, and epidemiology – will design recruitment strategies and data collection protocols for this massive longitudinal study. “The proposed main study will track roughly 10,000 children from fetal life through about 10 years of age to examine the short and long-term effects of prenatal substance exposure in the context of other social and environmental factors,” Chambers said, “During this initial planning phase, our team and others at 27 additional institutions across the nation will work to identify, test, and recommend strategies to engage and support participants in a respectful and ethical manner, and to outline a common protocol for the assessment of brain development, neurobehavioral performance and other health outcomes that will be integral components of the study.” The work done during this planning phase will inform future research on the effects of opioids and other substances in young children and identify new opportunities for intervention to support child development.
The HEALthy BCD Study was made possible by the National Institutes of Health’s Helping to End Addiction Long-term (HEAL) Initiative; under this initiative, nearly $1 billion in funding has been pledged to help tackle the national opioid crisis.
How Safe Are Mom’s Anxiety Medications On Her Unborn Baby?April 06, 2019
Up to 15% of pregnant women have an anxiety disorder, and 1-4% of them are treated with benzodiazepines (like Valium®, Xanax® or Klonopin®) or z-drugs (like Ambien®). In addition, it’s not uncommon for women with anxiety to also be treated for depression, or for benzodiazepines to be used in combination with a prescription opioid for pain management. But what effects might benzodiazepines and z-drugs, in isolation or in combination with an antidepressant or a prescription opioid, have on longer-term developmental outcomes in a pregnant woman’s baby? Our new study examined this very question.
How did we do it? We accessed a large dataset from the Norwegian Mother and Child Cohort Study, which followed over 41,000 pregnant women from 1999 to 2008 and had child follow-up data from 6 months to 8 years of age. In the study were 4,195 women who before and/or during pregnancy had a depression/anxiety disorder, 5,260 with a sleeping disorder, and 26,631 with a pain-related disorder. We looked at whether the timing of benzodiazepine/z-drug exposure (mid-pregnancy vs. late pregnancy) had any effects on the child’s longer-term development; whether longer vs. shorter duration of use (multiple 4-week vs. 1-week intervals) had any effect; and how the use of benzodiazepines/z-drugs in isolation or in combination with an antidepressant or a prescription opioid affected the child’s development. The child outcomes we looked at were the development of both motor and communication skills as well as attention problems when the children were around 5 years of age.
What did we find? Our findings suggested no increased risk for attention problems or fine motor deficits after benzodiazepine/z-drug exposure at different time points in pregnancy. We also did not find any evidence suggesting there was a developmental risk based on how long the mom used these drugs, nor any increased risk if benzodiazepines/z-drugs were used in combination with either antidepressants or a prescription opioid. There was an increased risk of gross motor and communication deficits among children whose mothers had depressive/anxiety disorders and used benzodiazepines/z-drugs late in pregnancy (week 29 or later), but the deficits were below clinically relevant cutoff points and could be accounted for by the mom’s underlying psychiatric conditions and/or the higher doses she was taking.
So what’s the take-away? Our findings suggest no substantial detrimental risk to child fine motor skills and attention problems after prenatal exposure to benzodiazepines/z-drugs alone or in combination with opioids or antidepressants. While an increased risk of gross motor and communication deficits was found, the deficits were not clinically significant and could be explained by other factors. As with any medication, pregnant women or women planning a pregnancy should talk with their healthcare provider before starting or stopping any medications.
Mommy’s Milk Team Finds Marijuana in Breast Milk Up To Six Days After UseAugust 27, 2018
With the legalization of marijuana in several US states, increased use has been seen in pregnant and breastfeeding women for both medicinal and recreational purposes. Although national organizations like the American Academy of Pediatrics recommend breastfeeding mothers do not use marijuana, there has been a lack of current data to support any health or neurodevelopmental concerns in infants as a result of exposure to tetrahydrocannabinol (THC) or other components of marijuana via breast milk.
“Pediatricians are often put into a challenging situation when a breastfeeding mother asks about the safety of marijuana use. We don’t have strong, published data to support advising against use of marijuana while breastfeeding, and if women feel they have to choose then we run the risk of them deciding to stop breastfeeding – something that we know is hugely beneficial for both mom and baby,” said Christina Chambers, PhD, MPH, principal investigator of the study, program director of Mommy’s Milk, and co-director of the Center for Better Beginnings.
Cannabinoids, marijuana’s active compounds, such as THC, like to stick to fat, which is abundant in breast milk. This stickiness has suggested that in women who use marijuana, these compounds can end up in breast milk, raising concerns about their potential effects on nursing babies.
To better understand how much marijuana actually gets into breast milk and how long it stays there, our Mommy’s Milk team conducted a study published online today in the journal Pediatrics. We examined 54 breast milk samples from 50 women who used marijuana either daily, weekly or sporadically – with inhalation being the primary method of intake. THC, the primary psychoactive component of marijuana, was detected in 63 percent of the breast milk samples up to six days after the mother’s last reported use.
“We found that the amount of THC that the infant could potentially ingest from breast milk was relatively low, but in some mothers could be detected as long as six days after the mother last used marijuana. We still don’t know enough about the drug to say whether or not there is a concern for the infant at any dose, or if there is a safe dosing level,” said Dr. Chambers. “The ingredients in marijuana products that are available today are thought to be much more potent than products available 20 or 30 years ago.”
Dr. Chambers believes that the results are a stepping stone for future research. More studies need to be done not only to determine the long-term impact for children, if any, of marijuana in breast milk, but more specifically, “are there any differences in effects of marijuana in breast milk for a two-month old versus a 12-month old, and is it different if the mother smokes versus eats the cannabis? These are critical areas we need answers to as we continue to promote breast milk as the premium in nutrition for infants.”
Study co-authors include: Kerri Bertrand, MPH; Nathan Hanan, PharmD; Gordon Honerkamp-Smith, MS; and Brookie Best, PharmD, MAS, all with UC San Diego.
Center Researchers Provide More Accurate Estimates of FASD in USFebruary 06, 2018
Fetal Alcohol Spectrum Disorders (FASD) are costly, life-long disabilities that are 100% preventable, but estimates of how commonly they occur have been outdated and based on small, non-diverse samples. Not any more! With funding from the National Institute on Alcohol Abuse and Alcoholism and working with colleagues at the University of North Carolina – Chapel Hill and the University of New Mexico, our experts recently published research that provides an updated estimate of how common FASD are in the United States, including right here in Southern California. What did we find? FASD are more common than previously thought, and may be as common as (and in some cases, more common than) autism. The study was published in the Journal of the American Medical Association.
To find out how common Fetal Alcohol Spectrum Disorders (FASD) are, our research team collaborated with other researchers to evaluate first-grade children in 4 regions of the United States. A total of 6,639 children were assessed on their physical growth, key facial features, and their cognitive and behavioral development, and their mothers were interviewed about alcohol use during their pregnancy with the participating child. Across the 4 study regions, we found that about 1% to 5% of children were estimated to have FASD. This was the most conservative estimate and assumed that no additional cases of FASD would have been found in children who did not participate in the study. But when we applied an alternate approach that assumed the prevalence of FASD that we found in participating children would be the same in non-participating children in each community, the estimated prevalence of FASD was even higher, ranging from about 3% to 10% of children.
So what does this mean? These estimates suggest that harmful levels of prenatal alcohol exposure are common in the U.S. today; they also highlight the public health burden due to FASD. A well-known developmental disorder, Autism Spectrum Disorders, is estimated to affect about 1.5% of children; our study suggests that FASD may be just as common as, and in some cases more common than, autism! According to Dr. George Koob, the director of the National Institute on Alcohol Abuse and Alcoholism, “FASD is a leading cause of developmental disabilities worldwide. Understanding the prevalence of FASD in the U.S. is needed to determine the public health burden of FASD and to identify the need for resources to treat the disorders. These findings underscore the need for targeted programs for children with FASD and for interventions to prevent alcohol use during pregnancy.
Nine Months Matter Public Awareness Campaign Launches to Promote Alcohol-Free PregnanciesOctober 23, 2017
UC San Diego’s Center for Better Beginnings and the newly formed volunteer task force, Better Beginnings Coalition, announce the launch of Nine Months Matter Advocacy Campaign—a public awareness event to alert the community that no amount of alcohol during pregnancy is safe. Nine Months Matter will educate the community on the effects of alcohol on a developing baby with the goal to reduce the number of children born in the U.S. with Fetal Alcohol Spectrum Disorders (FASD) by 80% by the year 2025. The campaign kicked off on September 30th at the La Jolla Beach and Tennis Club with Dr. Kenneth Lyons Jones, Center for Better Beginnings Co-Director, Dr. Miguel del Campo, Center for Better Beginnings Faculty Member and founding member of the European FASD Alliance, and Judge Marian Gaston with the Superior Court of San Diego County. The event was sponsored by the Morrison and Foerster Foundation and Quest Diagnostics.
In 1973 Dr. Jones and his mentor Dr. David Smith described Fetal Alcohol Syndrome and made the connection between brain injury in newborns and alcohol consumed during pregnancy. Children born with FASD have social, educational and behavioral disabilities. In school, these children have severe learning disabilities. In addition, they have a difficult time assessing right from wrong and don’t understand consequences; as a result, these children and young adults unfortunately often end up in the legal system.
Research has shown consuming alcohol during pregnancy is more dangerous to a developing baby than cocaine, heroin or methamphetamine. Misinformation is common; many times women are told by their physicians that having a drink or two while pregnant is safe. However, alcohol crosses the placenta and there is no time during pregnancy when it is safe to drink because the brain is constantly developing.
If you would like to join the Better Beginnings Coalition, contact campaign chair Mary Reynolds at [email protected]. Visit Nine Months Matter for more information or follow on Facebook at https://www.facebook.com/ninemonthsmatter/.
Risk for Developmental Delay Following Prenatal Alcohol Exposure May Be Detectable in Baby’s Heart Rate PatternJuly 28, 2017
Working with colleagues at the UC San Diego Jacobs School of Engineering and elsewhere, our experts recently published research suggesting that an early screen looking at certain changes in a baby’s heart rate pattern, called cardiac orienting response (COR), may be a better early predictor for developmental delay following prenatal alcohol exposure (PAE) that standardized developmental testing. Why is this important? The effects of PAE on a child’s development often are not diagnosed until the child begins to struggle in school, and standardized tests for developmental delay are often costly and labor-intensive. An easy and effective screening tool like COR could make it possible to identify and treat these children much earlier in life while their brains are still developing. The study was published in the journal Alcoholism: Clinical & Experimental Research.
Mommy’s Milk Lands Funding to Study Marijuana Use During LactationJune 08, 2017
One substance of rapidly growing public health interest is marijuana. With increasing access to legal recreational marijuana in the U.S., the question of the safety of its use during breastfeeding has risen in prominence. Nearly 11% of women who are either pregnant or breastfeeding use marijuana; however, there are insufficient data on marijuana use during pregnancy and lactation or the potential developmental consequences for exposed children.
In response to the pervasive lack of data in this area, Mommy’s Milk has been awarded a three-year $110,000 grant from the Gerber Foundation to measure the concentration of cannabinoids (the various components of the Cannabis sativa plant) in human milk and to examine selected infant health related outcomes.
This work will begin to fill an important gap in public health knowledge, and will ultimately help support clinical guidance and education regarding marijuana use during lactation for obstetricians and pediatricians alike.
Mommy’s Milk was established in 2014 at the University of California San Diego’s Center for Better Beginnings with support from Rady Children’s Hospital, San Diego. It is a national resource for multidisciplinary researchers seeking to study various aspects of breast milk in relation to health, disease and medication exposures. To date, 530 breast milk samples are stored and available for research purposes.
Study Principal Investigator Contact: Dr. Christina D. Chambers, 858-246-1704, [email protected]
Study Manager Contact: Kerri Bertrand, 858-246-1713, [email protected]
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