In a study of pregnant women, exposure to phthalates, a group of chemicals found in plastics and other household products, was associated with elevated blood pressure during late pregnancy, as well as long-term changes to blood pressure. The study by scientists at Columbia University Mailman School of Public Health is part of their broader findings on the impact of phthalates and cardiometabolic health and the first to examine long-term blood pressure trajectories in relation to phthalate exposure during pregnancy. Findings are published in the journal Environmental Health Perspectives.

Phthalates are ubiquitous in the environment in many consumer and household products, including children’s toys and vinyl flooring tiles, as well as scented products like perfumes and air fresheners. Human exposure to phthalates can occur through ingestion, inhalation, and skin absorption. Specific phthalates disrupt the endocrine system, the body’s system for regulating hormones, and exposure to these is linked to developmental health problems, including asthma, childhood brain development, IQ, and thyroid function.

The researchers analyzed urine samples collected from 892 pregnant women in Mexico City for concentrations of 9 phthalate compounds. Higher collective exposure to these compounds was associated with elevated blood pressure in the third trimester, as well as an increased likelihood of having unfavorable blood pressure postpartum.

“These findings suggest that exposure to phthalates during pregnancy may have life-long consequences on the blood pressure trajectory, potentially elevating the risk for chronic illnesses later in life, such as hypertension,” says first author Haotian Wu, PhD, an associate research scientist in the Department of Environmental Health Sciences at Columbia Mailman School.

In an accompanying editorial, Ivan A. Arenas MD, PhD, Columbia University Division of Cardiology, writes, “the study by Wu and colleagues opens new avenues for research on the role of environmental exposures and blood pressure levels, specifically on the effect of phthalates on pathways regulating blood pressure. The authors used an elegant statistical strategy for the analysis of blood pressure changes after pregnancy in a relatively large cohort of pregnant women. This study provides further evidence that the exposure to synthetic chemicals in food contact materials may result in alterations on cardiovascular function.”

In an earlier study of the same group of pregnant women (the PROGRESS cohort—Programming Research in Obesity, Growth, Environment and Social Stressors) researchers found that phthalate exposure during pregnancy may be associated with markers of metabolic health up to eight years post-delivery and that prenatal maternal phthalate exposures and trajectories of excess body fat from 4 to 12 years.

The researchers say the potential biological mechanisms that underlie the associations of phthalate biomarkers and maternal blood pressure are unclear. They say future studies are necessary on potential changes to blood pressure trajectories in early pregnancy, as well as other long-term health consequences. “There is a paucity of research examining phthalate exposures and maternal health, particularly in the years following pregnancy. Our findings suggest that prenatal exposures to phthalates may influence women’s cardiometabolic health and will hopefully stimulate future research regarding potential changes to blood pressure, and other risk factors, during early pregnancy, as well as long-term consequences,” says Andrea Deierlein, PhD, senior author, and assistant professor of public health nutrition at NYU School of Global Health.

The study was supported by grants from the National Institute of Environmental Health Sciences (ES023474, ES027508, ES021357, ES009089, ES024381, ES023515, ES013744, ES014930, ES028522).  

Study co-authors include Allison Kupsco and Andrea Baccarelli at Columbia Mailman; Allan Just, Alison Sanders, and Robert Wright at Icahn School of Medicine at Mount Sinai; Antonia Calafat at the U.S. Centers for Disease Control and Prevention; Emily Oken at Harvard Medical School; Joseph Braun at Brown University; Adriana Mercado-Garcia, Alejandra Cantoral, and Martha Téllez-Rojo at National Institute of Public Health, Morelos, Mexico; Ivan Pantic, National Institute of Perinatology, Mexico City; and Andrea L. Deierlein, New York University.

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PHENIX CITY, Ala. (AP) — Sometimes when she’s feeding her infant daughter, Amanda Harrison is overcome with emotion and has to wipe away tears of gratitude. She is lucky to be here, holding her baby.

Harrison was 29 weeks pregnant and unvaccinated when she got sick with COVID-19 in August. Her symptoms were mild at first, but she suddenly felt like she couldn’t breathe. Living in Phenix City, Alabama, she was intubated and flown to a hospital in Birmingham, where doctors delivered baby Lake two months early and put Harrison on life support.

Kyndal Nipper, who hails from outside Columbus, Georgia, had only a brief bout with COVID-19 but a more tragic outcome. She was weeks away from giving birth in July when she lost her baby, a boy she and her husband planned to name Jack.

Now Harrison and Nipper are sharing their stories in an attempt to persuade pregnant women to get COVID-19 vaccinations to protect themselves and their babies. Their warnings come amid a sharp increase in the number of severely ill pregnant women that led to 22 pregnant women dying from COVID in August, a one-month record.

“We made a commitment that we would do anything in our power to educate and advocate for our boy, because no other family should have to go through this,” Nipper said of herself and her husband.

Harrison said she will “nicely argue to the bitter end” that pregnant women get vaccinated “because it could literally save your life.”

Since the pandemic began, health officials have reported more than 125,000 cases and at least 161 deaths of pregnant women from COVID-19 in the U.S., according to the U.S. Centers for Disease Control and Prevention. And over the past several months, hospitals and doctors in virus hot spots have reported a sharp increase in the number of severely ill pregnant women.

With just 31% of pregnant women nationwide vaccinated, the CDC issued an urgent advisory on Sept. 29 recommending that they get the shots. The agency cautioned that COVID-19 in pregnancy can cause preterm birth and other adverse outcomes, and that stillbirths have been reported.

Dr. Akila Subramaniam, an assistant professor in the maternal-fetal medicine division of the University of Alabama at Birmingham, said the hospital saw a marked rise in the number of critically ill pregnant women during July and August. She said a study there found the delta variant of COVID-19 is associated with increased rates of severe disease in pregnant women and increased rates of preterm birth.

“Is it because the delta variant is just more infectious or is it because delta is more severe? I don’t think we know the answer to that,” Subramaniam said.

When COVID-19 vaccines became available to pregnant women in their states this spring, both Harrison, 36, and Nipper, 29, decided to wait. The shots didn’t have final approval from the Food and Drug Administration and pregnant women weren’t included in studies that led to emergency authorization, so initial guidance stopped short of fully recommending vaccination for them. Pfizer shots received formal approval in August.

The women live on opposite sides of the Alabama-Georgia line, an area that was hit hard by the delta variant this summer.

While Harrison had to be put on life support, Nipper’s symptoms were more subtle. When she was eight months pregnant, she lost her sense of smell and developed a fever. The symptoms went away quickly, but Jack didn’t seem to be kicking as much as he had been. She tried drinking a caffeinated beverage: Nothing. She headed to the hospital in Columbus, Georgia, for fetal monitoring where medical staff delivered the news: Baby Jack was gone.

“He was supposed to come into the world in three weeks or less,” Nipper said. “And for them to tell you there’s no heartbeat and there is no movement …”

Nipper’s doctor, Timothy Villegas, said testing showed the placenta itself was infected with the virus and displayed patterns of inflammation similar to the lungs of people who died of COVID-19.

The infection likely caused the baby’s death by affecting its ability to get oxygen and nutrients, Villegas said. The doctor said he has since learned of similar cases from other physicians.

“We’re at that point where everybody is starting to raise some red flags,” he said.

In west Alabama, Dr. Cheree Melton, a family medicine physician who specializes in obstetrics and teaches at the University of Alabama, said she and her colleagues have had about a half-dozen unvaccinated patients infected with COVID-19 lose unborn children to either miscarriages or stillbirth, a problem that worsened with delta’s spread.

“It’s absolutely heartbreaking to tell a mom that she will never get to hold her living child,” she said. “We have had to do that very often, more so than I remember doing over the last couple of years.”

Melton said she encourages every unvaccinated pregnant woman she treats to get the shots, but that many haven’t. She said rumors and misinformation have been a problem.

“I get everything from, ‘Well, somebody told me that it may cause me to be infertile in the future’ to, ‘It may harm my baby,’” she said.

Nipper said she wishes she had asked more questions about the vaccine. “Looking back, I know I did everything that I could have possibly done to give him a healthy life,” she said. “The only thing I didn’t do, and I’ll have to carry with me, is I didn’t get the vaccine.”

Now home from the hospital with a healthy baby, Harrison says she feels profound gratitude — tempered with survivor’s guilt.

“I cry all the time. Just little things. Feeding her or hugging my 4-year-old. Just the thought of them having to go through life without me and that’s a lot of people’s reality right now,” Harrison said. “It was very scary and it all could have been prevented if I had gotten a vaccination.”

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It’s 1 a.m. and I’m squinting in the bathroom light, glancing between the safety information on a bottle of antacids and the search engine I just opened on my phone. Was it magnesium containing supplements or calcium carbonate that should be avoided in pregnancy? I’m an internal medicine physician in the second trimester of my second pregnancy, though at this hour my experience is irrelevant. I cannot recall the laundry list of forbidden items that may potentially harm my growing baby.

The irony, I think, as I chew the chalky pill, is that my heartburn seems so trivial in comparison to the decision I recently made to receive the COVID-19 vaccine.

The choice was anything but straightforward given the lack of evidence; clinical trials did not initially include my demographic — pregnant women. Like most physicians, I find comfort in graphs and statistics, and it was unsettling to make a critical decision about my health on the basis of inference. After researching how mRNA vaccines work and speaking with my infectious disease colleagues, I was convinced these vaccines had no plausible mechanism to pose risk to my future daughter. I received both doses of the Pfizer vaccine, and wrote about my journey, hoping it would prove useful to others attempting to wade through the sea of conflicting advice. My baby and I are healthy, and it was reassuring to watch her somersault on her 20-week ultrasound. Still, I can’t help but wonder: Why was it up to me, the patient, to speculate on what clinical trial data might have shown?

As in so many other areas, the COVID-19 pandemic has exposed the fractures in our status quo. A true assessment of a drug’s efficacy requires testing in pregnant women to determine if it is safe in utero. Yet this is rarely studied. A 2013 study, which reviewed 558 industry-sponsored clinical trials, showed that only 1% were designed specifically for pregnant women. Of the 367 trials that specified exclusions, 95% excluded pregnant women.

In fairness to researchers, pregnant women do not make for straightforward test subjects. There are physiologic changes in the heart, kidneys, lungs, thyroid, and liver, all of which adapt their function to the task of growing another human. This alters how a drug may be absorbed, distributed through the body and metabolized. Data from a non-pregnant woman cannot simply be extrapolated to a pregnant woman. Physiology also changes throughout pregnancy; a pharmaceutical agent tested in the first trimester may have different effects later in gestation.

The lack of research places doctors such as myself in a precarious position when counseling pregnant or lactating women, who also are omitted from randomized controlled trials. Though I am not an obstetrician, my reproductive-age patients often ask me about safe medications as they grow their family. Without evidence to point to, my advice sounds like a poorly written “choose your own adventure” story. It is unsatisfying for both patient and clinician.

The exclusion of pregnant women from trials was intended as a protective mechanism for both mother and baby, noting the ethical dilemma of exposing two lives to an untested substance, especially when one of them is unable to give consent. Nobody wants history to repeat itself; inadequate studies in utero on pharmaceuticals such as thalidomide and diethylstilbesterol (DES) proved catastrophic. Pregnant women were labeled as “a vulnerable population” by the Office for Human Research Protections (a part of the U.S. Department of Health and Human Services), along with children, the disabled and incarcerated individuals. Research on these populations has stringent limitations and protocols, which ultimately limits the type of studies that may be done.

This additional safeguarding remained until the 21st Century Cures Act removed the “vulnerable” label, reflecting a shift from “protection from research” to “protection through research.” The debate is an emotionally charged one. Is it paternalistic to prevent a woman from participating in studies on medications that may directly affect her health? Does subjecting a fetus that cannot consent to the risks of participating in an experiment violate the very principle of medicine — do no harm?

Like many ethicists and advocates for better representation in clinical trials, I worry that strict adherence to ‘do no harm’ by means of exclusion poses harm in and of itself. We saw this early in the AIDS epidemic, when antiretroviral therapies were avoided in pregnant patients because of unknown risk. Once clinical trials were conducted in this population, we saw tremendous benefits. The drug in question, zidovudine or AZT, resulted in a striking 67.5% relative reduction in perinatal HIV transmission.

In another example, pregnant and breastfeeding women were not offered the experimental Ebola vaccine at the same time as other women. Lives were lost during this delay.

I frequently see this scenario unfold when it comes to medications for depression, for which patients frequently take selective serotonin reuptake inhibitors (SSRIs). Some studies have shown an increased risk of birth defects from the medications paroxetine and fluoxetine, but not from other SSRIs. And of course, none of these studies were randomized controlled trials that included pregnant women, but mostly case-control studies. The overall risk of birth defects with SSRIs is low. It must be weighed against the risk of depression relapse in an untreated mother and the downstream effects of prepartum depression, such as low birth weight and increased risk of substance abuse.

A healthy baby is wholly dependent on a healthy mother, but it is challenging to present a risk-benefit analysis to a mother who would gladly sacrifice her own health to reduce even the slightest chance of harm to her fetus. I remember trying to convince a woman with severe depression to consider continuing her SSRI while trying to conceive. “But you just told me the studies weren’t good and we don’t have enough evidence,” she said, aghast. “So you want my baby to be the guinea pig?”

I know how she felt. My decision to get vaccinated for COVID-19, without data on pregnancy, felt a bit reckless. Had I been able to enroll in a clinical trial, I would have been afforded all the protections that come with being a test subject — more frequent office visits, ultrasounds, blood work, and oversight by a clinician who knows more about fetal development than I do.

But declining the vaccine would have felt even more reckless. Vaccination has given me a newfound sense of safety and comfort, after a year in which little about patient care has felt safe or comfortable and after becoming pregnant left me feeling further exposed and vulnerable to a disease whose effects on my fetus are unknown. I had hoped that sharing my decision would lend this sense of comfort to patients, pregnant or otherwise, who felt uneasy about vaccination. But I am unsure that I have swayed any minds.

Those who received the COVID-19 vaccine were eager to do so before hearing my perspective. Those who are reluctant wonder how I dared to make such a rash decision when the long-term effects of the vaccine on my baby’s development are yet unknown.

As a silver lining, the pandemic has led to even greater advocacy for the inclusion of pregnant and lactating women in trials. The key will be in incentivizing often-reluctant pharmaceutical companies to include women, and encouraging pregnant women to volunteer as subjects.

I’ve decided that the best form of advocacy is in action. In my third trimester, I will be participating in a vaccine trial for the respiratory syncytial virus (RSV), a leading cause of respiratory infections and viral pneumonia in infants. The study posits that vaccination in the third trimester of pregnancy will pass maternal antibodies that protect the infant. If it works, I won’t have just anecdotal experience, but real data I can show my patients.

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