Safety and Efficacy of Praziquantel in Pregnant Women Infected with Schistosoma haematobium in Lambaréné, Gabon - Clinical Results from the Randomized, Single-Blinded, Controlled freeBILy-Gabon Trial.

Despite evidence of praziquantel's safety for treating schistosomiasis in pregnancy, many countries withhold treatment. Only two randomized controlled trials have investigated praziquantel in pregnancy, none involving Schistosoma haematobium. Pregnant women during second trimester in Lambaréné (Gabon) were screened for S. haematobium infection using urine microscopy and circulating anodic antigen detection. Participants positive for either test were randomized (3:1) to single-dose praziquantel 40mg/kg during pregnancy versus no treatment during pregnancy. Investigators were blinded for allocation. Primary outcomes were reduction of egg- (ERR) and antigen production (IRR) while explorative outcomes included assessment of cure rate, adverse events, maternal hemoglobin levels maternal anemia prevalence at delivery, pregnancy outcomes, and newborn anthropometric parameters. Of 761 women screened 165 were eligible and randomized (intervention n=124, control n=41). 124 completed the study (n=90 and n=34, respectively). Tretament led to a significant higher ERR (95.0%[91%-97%] vs. 27.0%[-42%-63%]) and IRR (95%[91%-97%] vs. 56%[14%-78%]). Common adverse events were dizziness, nausea, and vomiting. Maternal anemia at delivery was significantly lower in the intervention group (OR:0.40[0.16;0.96],p=0.04). No increased risk for adverse pregnancy outcomes was observed. This first randomized controlled trial investigating praziquantel in pregnant women with S. haematobium found praziquantel to be safe, effective and reducing maternal anemia. We recommend treating confirmed infections to prevent morbidity in pregnant women.

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Declaration of interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.