S. Japonicum and Pregnancy Outcomes
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      This double-blind, placebo-controlled study will investigate praziquantel (PZQ) for the
      treatment of Schistosomiasis japonicum in pregnant women living in endemic villages of Leyte,
      The Philippines. The study will enroll 375 pregnant women, ages 18 and over, infected with S.
      japonicum. The primary study objective is to quantify the efficacy of PZQ treatment for S.
      japonicum at 12-16 weeks gestation on newborn birth weight among live births. This will be
      assessed by measuring birth weight within 96 hours of delivery to 10 grams. The secondary
      objectives are to: 1) assess treatment efficacy with respect to maternal and newborn
      nutritional status and maternal parasitologic response to treatment; 2) collect preliminary
      safety and toxicity data on use of PZQ among pregnant women and their newborns; 3) identify
      extra-placental mechanisms mediating the hypothesized beneficial effect of PZQ on birth
      outcomes; and 4) identify extra-placental mechanisms mediating the hypothesized beneficial
      effect of PZQ on birth outcomes. Participants will be involved in study related procedures
      for 9 months (8 months pre-natally and 1 month post-natally) for mother and infant. This
      study is linked to DMID protocol 08-0049.
    

Intervention name(s): Praziquantel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 60 mg/kg administered orally given in split dose (30/mg/kg each) separated by 3 hours; over-encapsulated in gelatin capsules. Two capsule sizes will be made which will be differentiated by color; these will contain 300 mg or 150 mg to allow for best dosing by weight.; Made with the same color coded gelatin capsules with the inert compound dextrose.
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Philippines, Schistosoma japonicum, Schistosomiasis, pregnant women, fetuses, 08-0049