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Even when clinical trials involving pregnant women are approved, they are often limited by funding constraints and the ethical considerations of working with this patient population.

“You have to be cautious when investigating new treatments in pregnant women,” Burwick says. “But I believe there is strong rationale to include them in clinical trials, especially when faced with a disease such as COVID-19, where there is risk of serious harm to both mother and fetus.”

A severe case of COVID-19 can mean long-term tissue damage or undesirable outcomes like premature delivery or, in very severe cases, maternal death.

“The literature says the risk of premature delivery for pregnant women with severe COVID-19 illness is 30-40%. This is not because COVID-19 causes early labor, but because the patient’s COVID-19 illness is worsening and providers have few treatment options besides premature delivery.”

With little research available, physicians resort to prescribing drugs off-label or that have been approved for compassionate use. Sometimes, they choose not to prescribe drugs at all due to a lack of safe options or fear of adverse effects to the fetus.

“Excluding expectant mothers from clinical trials could potentially lead to increased harm, because providers and patients are hesitant about new treatments that lack safety and efficacy data in pregnancy,” says Burwick.

Burwick believes there is a better way, noting that prescribing drug therapies through clinical trials—with a protocol approved by the Food and Drug Administration and the Cedars-Sinai Institutional Review Board (IRB)—is safer than prescribing them off-label or via compassionate use approvals. Clinical trials also allow superior data collection compared to retrospective investigations.

Targeting the immune response to defeat COVID-19

Since the beginning of the pandemic, physicians have searched for safe, effective treatment protocols for pregnant women with COVID-19. One drug—eculizumab—shows promise. Eculizumab targets the complement system and works by lowering immune-mediated inflammation and tissue damage, so the body can heal from illness and stop attacking its own healthy cells.

COVID Treatment for Pregnant Girls

“The complement system is your innate immune system,” says Burwick. “In a disease like COVID-19, you have no antibodies, and you rely on your innate immune system for immediate defense against foreign pathogens.”

In some cases of severe illness, Burwick says, the body’s innate immune system works too well.

“When a foreign pathogen is introduced—COVID-19 in this case—your complement system tags the virus as a foreign body and triggers your immune system to attack. But when the virus has replicated in large volume and spread deep into healthy tissue, your immune system can mistakenly begin to attack and damage healthy cells.”

Drugs like eculizumab block the membrane attack complex, the final complex formed in the complement system cascade, and prevent the body from causing additional injury to itself.

Eculizumab has been FDA-approved for more than 10 years to treat two rare blood disorders, and has yielded good safety data when used in pregnant and lactating women. It’s unique design limits transport across the placenta during pregnancy and it doesn’t get into breast milk, unlike many other monoclonal antibody therapies.

Encouraged by similar trials using complement blockades to treat COVID-19 patients, Burwick launched a small study that uses eculizumab to treat pregnant and lactating women with severe or critical forms of the illness. Initial data is encouraging.

Does COVID-19 impact pregnant women differently?

We have been watching this closely. Recent studies suggest that pregnant patients are at higher risk of severe disease and worse outcomes from COVID-19 than non-pregnant peers, including intensive care admission, requiring a ventilator and death. These risks are higher for women of color, including African-American and Hispanic populations.

Adverse pregnancy outcomes such as preterm birth for COVID-positive patients have also been reported but data in this area are still evolving.

People with some health conditions, such as diabetes, lung disease, or heart disease, also have a higher risk of becoming sicker from COVID-19.

Should pregnant women take extra precautions?

There is nothing about pregnancy itself that makes a woman more susceptible to being infected. However, given the risk of severe illness from COVID-19 during pregnancy, we recommend pregnant individuals take all precautions possible to protect themselves from the virus. This includes proper handwashing (at least 20 seconds using warm water and soap), not touching your face, nose, eyes or mouth and following aggressive social distancing (not going out unless you absolutely have to and staying six feet apart from others.)

COVID Treatment for Pregnant Women

Transmission spreads from person to person primarily through close contact with respiratory droplets (such as through coughs and sneezes) that can travel up to six feet.

The Centers for Disease Control has also recommended that community members wear cloth masks if they have to go somewhere like the grocery store. You do not need to wear a surgical mask or medical-grade mask.

Can a baby be infected from breastmilk?

So far the virus has not been found in breastmilk and there’s no evidence to suggest it’s transmittable this way. However, the close contact with a COVID-19-positive caregiver while feeding a baby would increase risk of spreading the virus.

This is why we recommend that delivering moms who test positive for the virus and choose to breastfeed consider pumping milk during a temporary period after birth to protect newborns from the risk of contracting the virus.

Are symptoms different in pregnant women?

A small study of 215 pregnant women at two New York hospitals recently found a surprising number of asymptomatic women who tested positive for the novel coronavirus. Of the 33 women who tested positive, 29 (88%) did not have symptoms.

This doesn’t necessarily mean COVID-19-positive pregnant women are less likely to show symptoms. It does, however, offer us clues about the prevalence of people who have unknowingly been infected with the virus and aren’t showing symptoms but are still contagious – among both pregnant women and the general population.

What should you do if you’re pregnant and think you have COVID-19?

If you think you may have been exposed to the coronavirus and have a fever or cough, call your health care provider.

Symptoms to watch out for include a hard time breathing or shortness of breath that is more than what has been normal during your pregnancy, ongoing pain or pressure in your chest, blue lips, confusion or inability to respond to others.

Should pregnant women be changing what they eat or drink?

There is likely a very low risk of spread from food products or packaging that are shipped at refrigerated, or frozen temperatures.

There is also no evidence that any specific foods or drinks help prevent being infected with the virus – which has falsely been shared on some websites and social media.

Research desperately needed

Severe illness and adverse birth outcomes were observed among hospitalized pregnant women with COVID-19. Further research is desperately needed, according to Dr. Goje, on COVID-19 in pregnancy, including what impact other comorbidities may have on outcomes in this population. The limited data that exist about transmission of COVID-19 during pregnancy and delivery indicate that the virus may cross and infect the placenta, which raises concerns about vertical transmission.

That very issue will be investigated in the collaborative study between Cleveland Clinic, University Hospitals Cleveland Medical Center, and Cleveland’s MetroHealth System, in conjunction with Case Western Reserve University and the National Institutes of Health. Key questions include when transmission might occur during pregnancy and what the effects are for both maternal and fetal health.5 These findings highlight the importance of preventing and identify­ing COVID-19 in pregnant women.

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