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A study by Rhode Island Hospital researchers confirmed that a drug used to treat a disease afflicting millions of people in developing countries is safe to give pregnant women following their first trimester. The finding could prove critical to the care of pregnant women and lactating women with schistosomiasis, a disease caused by a parasitic worm, who were denied the drug out of concern for their health and the health of their fetuses.
Authored by Jennifer F. Friedman, MD, PhD, MPH, director of clinical studies for the Center for International Health Research at Rhode Island Hospital, the study found that praziquantel does not lead to adverse events for the pregnant woman or her newborn. The study was published today in The Lancet Infectious Diseases.
"Millions of women, many of whom are in a multi-year, cyclical pattern of pregnancy and breast-feeding, are denied praziquantel," says Friedman. "The accumulation of evidence shows that commencement of this treatment after the first trimester does not adversely affect the mother or fetus. We wanted to conduct this study to demonstrate that this drug is safe after the first trimester, and we remain hopeful that public health policies will change. Deferring treatment only exacerbates the morbidity of the patients."
Nearly 40 million women of reproductive age are infected with schistosomes. They are a significant cause of disease in developing countries. Despite World Health Organization recommendations to offer pregnant women treatment with praziquantel, many nations continue to withhold treatment, awaiting safety and efficacy data from controlled drug trials such as this one.
Schistosomiasis is transmitted during contact with freshwater containing snails that have been infected due to poor sanitation practices. It is known to cause damage to the kidneys, liver, bladder and other organs. After malaria, schistosomiasis is the most common parasitic disease, affecting 200 million people throughout the world and kills approximately 280,000 people annually.
No previous study has examined whether praziquantel treatment at 12-16 weeks gestation improves pregnancy outcomes or whether the use of a higher dose of praziquantel recommended to treat Asian schistosomiasis can be safely administered without adverse newborn or maternal outcomes. This research study, conducted in the Philippines, found that treatment did not positively impact birth weight, however, the iron status of the mothers and newborns improved in the treated group.
The study was supported by a grant from the United States National Institutes of Health, National Institute of Allergy and Infectious Diseases (U01AI066050)
Jennifer F. Friedman, MD, PhD, MPH's principal affiliation is Rhode Island Hospital, a member hospital of the Lifespan health system in Rhode Island. She also holds an academic appointment at Alpert Medical School of Brown University. Other researchers contributing to the study were: Remigio M. Olveda, MD, Luz P. Acosta, PhD, Palmera I. Baltazar, MD, Jenny Lind S. Lesiguez, MD, Georgette G. Estanislao, MD, Edna B. Ayaso, MD, Donna Bella S. Monterde, MD, Antonio Ida, MD, and Beronica Tallo, PhD, all from the Research Institute of Tropical Medicine, Manila; Emily A. McDonald, PhD, Hannah W. Wu, PhD, Jonathan D. Kurtis, PhD, all of Rhode Island Hospital and Alpert School of Medicine of Brown University; and Nora Watson, MS, PhD, EMMES Corporation, Rockville, Md.