How do Malaria Drugs Affect Pregnancy? USU Researchers to Launch Study

Researchers from the Uniformed Services University of the Health Sciences (USU) Department of Pediatrics will soon be launching a study on how malaria drugs affect pregnant women and their unborn children. 

The USU Department of Pediatrics is starting research on the impact of malaria drugs on pregnant women and their fetuses. Principal Investigator, USU assistant professor Dr. Elizabeth Lee and assistant professor Maj. (Dr.) Alison Helfrich hope their research may be able to expand the options of malaria prophylaxis medication for pregnant women. (Photo credit: Ian Neligh, USU)
The USU Department of Pediatrics is starting research on the impact of malaria drugs on 
pregnant women and their fetuses. Principal Investigator, USU assistant professor Dr. 
Elizabeth Lee and assistant professor Maj. (Dr.) Alison Helfrich hope their research may be 
able to expand the options of malaria prophylaxis medication for pregnant women. (Photo credit: 
Ian Neligh, USU)

August 10, 2023 by Ian Neligh

Malaria infections can be severe or even deadly, especially for those without preexisting immunity, such as travelers. Last year, 30 service members were infected with malaria while traveling to endemic areas, up 42 percent from 2021. The available preventive medication options, or malaria prophylaxis, help to keep cases low when combined with other preventive measures such as insect repellents and repellent-treated clothing.

Researchers from the Uniformed Services University of the Health Sciences (USU) Department of Pediatrics will soon be launching a study on how malaria drugs affect pregnant women and their unborn children. 

According to USU assistant professor of Pediatrics Air Force Maj. (Dr.) Alison Helfrich, “Pregnant people are at higher risk for complications of malaria, including poor outcomes for both the mother and baby. Therefore, it is extremely important (for them) to be on prophylaxis while traveling to a malaria-endemic country.”

“We hope to specifically address the gap in safety evidence for malaria prophylaxis use during pregnancy and the outcomes for mothers and their infant,” says the study’s Principal Investigator and USU assistant professor of Pediatrics Dr. Elizabeth Lee. 

Unrecognized pregnancies do happen in conjunction with deployment, albeit rare, according to Helfrich. She says women account for 17 percent of all active duty service members, 97 percent of whom are of reproductive age. So there is a chance these service members could be prescribed prophylaxis not currently approved for use in pregnancy.

Melissa Greenleaf, Clinical trials manager at the Walter Reed Army institute of Research's Clinical  Trials Center, injects participant Melanie Limerick with the FMP013 Malaria vaccine during a clinical trial.  The trial involves a series of three injections of the vaccine followed by direct exposure to Malaria, ultimately  aiming to find a safe and effective vaccine against Malaria. Last year, malaria infected 30 service members while traveling to endemic areas, up 42 percent from 2021. (Photo credit: U.S. Army photo by Mike Walters/Released)
Melissa Greenleaf, Clinical trials manager at the Walter Reed Army institute of Research's Clinical 
Trials Center, injects participant Melanie Limerick with the FMP013 Malaria vaccine during a clinical trial. 
The trial involves a series of three injections of the vaccine followed by direct exposure to Malaria, ultimately 
aiming to find a safe and effective vaccine against Malaria. Last year, malaria infected 30 service members while
traveling to endemic areas, up 42 percent from 2021. (Photo credit: U.S. Army photo by Mike Walters/Released)
“Unfortunately, because pregnant women aren’t routinely included in pre-marketing drug clinical trials, we do not know if the other available malaria medications are safe to use in pregnancy,” Helfrich says.

Lee adds the limited range of products available for women is a challenge for the military because, as the population of active-duty continues to include more women, more women of reproductive age will be deployed overseas for short-  and long-term duty.

Lee says the team’s research will include identification of pregnancies through the Military Health System data repository, probable exposure to malaria prophylaxis including those approved and not approved for pregnancy, and associated outcomes for mothers and their infants.

The research builds on an existing USU Infectious Disease Clinical Research Program-supported study already looking at infectious disease outcomes for deployment and traveler health, including sexually transmitted infections, diarrhea and malaria. The researchers expect the malaria prophylaxis in pregnancy study to begin later this fall.

“We hope that our research may be able to expand the options of malaria prophylaxis medication for pregnant women,” says Helfrich. “Our findings have the potential to impact health and safety for active-duty service women and federal travelers, as well as short- and long-term travelers to malaria-endemic areas, and their families.”