The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the
mother and developing baby when the mother has schistosomiasis (a type of worm) infection,
and whether the drug may improve the mother's and baby's health. The usual practice is to
wait until after a mother has finished breast feeding before giving the medicine.
Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte,
The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or
an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be
collected before and after the medication is taken. Three stool and urine samples will be
taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn
baby) will be performed. When the baby is born, a small blood sample will be taken. Mother
and baby will be followed for up to 8 months before the baby is born and 1 month after.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)