Drug Safety and Pregnant Women During COVID


NASHVILLE, Tenn. (Ivanhoe Newswire)— As the race continues to find a universal effective treatment for COVID-19, one group of critical patients is left out of clinical trials. More on how researchers are simulating trials for pregnant women that could save both mom and baby.

New data from the CDC reports that pregnant women are at an increased risk of suffering severe COVID-19 illness.

“The virus enters via a receptor known as ACE2. And pregnant women, it’s been shown that their lungs actually contain an abundance compared to a normal person,” explained Anup Challa, principal investigator at MADRE, Modeling Adverse Drug Reactions in Embryos.

(Read Full Interview)

But treatment can be tricky.

“We don’t have any existing standard of care for pregnant women with COVID-19. We don’t have a drug we can give them. We don’t have clinical trials that we can enroll them in,” elaborated Challa.

There’s a concern that any medicine prescribed to the mother could harm the baby. Instead …

“It may be important for the patient to deliver,” added David Aronoff, MD, Director of the Division of Infectious Diseases at Vanderbilt University Medical Center.

Twenty percent of pregnant women with COVID delivered prematurely compared to the national average of ten percent before the COVID pandemic started. But by using electronic health records, these researchers are simulating trials for pregnant women to find the best course of treatment without having to deliver.

“We can use high-powered statistics, tools like machine learning to look at cases in which pregnant women have been exposed to drugs either similar to the experimental therapeutics,” clarified Challa.

They’ve used this method for other health conditions with success.

“Nifedipine, which was already believed to be safe for use in managing high blood pressure in pregnancy, may also be useful in the context of diabetes in pregnancy,” explained Dr. Aronoff.

But when it comes to COVID-19, any promising information can be a special delivery for both mom and baby.

Pregnant women are five times more likely to be hospitalized if they contract COVID-19. At some hospitals, the drug remdesivir has been used to treat pregnant patients with COVID.

Contributors to this news report include: Cyndy McGrath, Executive Producer; Milvionne Chery, Field Producer; Bruce Maniscalco, Videographer; Roque Correa, Editor.

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REPORT:        MB #4775

PREGNANCY COMPLICATIONS: Some women experience health problems during pregnancy. These complications can involve the mother’s health, the health of the fetus, or both. Even women who were healthy before getting pregnant can experience complications. These complications may make the pregnancy high-risk. Early and regular prenatal care can help decrease the risk for problems by enabling health care providers to diagnose, treat, or manage conditions before they become serious. Common complications of pregnancy include, but are not limited to high blood pressure, gestational diabetes, infection, preeclampsia, preterm labor, miscarriage, and stillbirth.

(Source: https://www.nichd.nih.gov/health/topics/pregnancy/conditioninfo/complications)

DRUG TREATMENTS IN PREGNANCIES: Pregnancy is a special physiological condition where drug treatment presents a special concern because the physiology of pregnancy affects the pharmacokinetics of medications used and certain medications can reach the fetus and cause harm. Total avoidance of pharmacological treatment in pregnancy is not possible and may be dangerous because some women enter pregnancy with medical conditions that require ongoing and episodic treatment (e.g. asthma, epilepsy, hypertension). Also, during pregnancy new medical problems can develop and old ones can be exacerbated (e.g. migraine, headache) requiring pharmacological therapy. The fact that certain drugs given during pregnancy may prove harmful to the unborn child is one of the classical problems in medical treatment. In 1960’s pregnant ladies who ingested thalidomide gave birth to children with phocomelia. Various other examples of teratogenic effects of drugs are known. It has been documented that congenital abnormalities caused by human teratogenic drugs account for less than 1% of total congenital abnormalities. Hence in 1979, Food and Drug Administration developed a system that determines the teratogenic risk of drugs by considering the quality of data from animal and human studies. FDA classifies various drugs used in pregnancy into five categories, categories A, B, C, D and X. Category A is considered the safest category and category X is absolutely contraindicated in pregnancy. This provides therapeutic guidance for the clinician.

(Sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810038/)

UTILIZING ELECTRONIC HEALTH RECORDS: A lack of knowledge leads to undertreatment of chronic and acute illness in pregnant people, while also posing additional risk of adverse drug reactions. The solution according to Anup Challa is to use electronic health records data to emulate randomized controlled trials. Provided enough data, investigators can design and conduct “trials” that simulate not only a real trial’s treatment strategies (drug versus no drug) and outcomes, but also eligibility criteria and random assignment to treatment at baseline. According to the study such trials are arguably “the only ethical way to gather human drug exposure data for pregnant people on a significant scale and across all classes of drugs”.

(Source:  https://news.vumc.org/2020/05/27/target-trials-support-drug-safety-in-pregnant-patients/)





If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

Doctor Q and A

Read the entire Doctor Q&A for Anup Challa, Principal Investigator

Read the entire Q&A