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Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial

dc.rights.licenseopenen_US
dc.contributor.authorMANDELBROT, L.
dc.contributor.authorKIEFFER, F.
dc.contributor.authorSITTA, R.
dc.contributor.authorLAURICHESSE-DELMAS, H.
dc.contributor.authorWINER, N.
dc.contributor.authorMESNARD, L.
dc.contributor.authorBERREBI, A.
dc.contributor.authorLE BOUAR, G.
dc.contributor.authorBORY, J. P.
dc.contributor.authorCORDIER, A. G.
dc.contributor.authorVILLE, Y.
dc.contributor.authorPERROTIN, F.
dc.contributor.authorJOUANNIC, J. M.
dc.contributor.authorBIQUARD, F.
dc.contributor.authorD'ERCOLE, C.
dc.contributor.authorHOUFFLIN-DEBARGE, V.
dc.contributor.authorVILLENA, I.
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTHIEBAUT, Rodolphe
dc.date.accessioned2020-12-07T07:44:39Z
dc.date.available2020-12-07T07:44:39Z
dc.date.issued2018-10
dc.identifier.issn1097-6868 (Electronic) 0002-9378 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/21306
dc.description.abstractEnBACKGROUND: The efficacy of prophylaxis to prevent prenatal toxoplasmosis transmission is controversial, without any previous randomized clinical trial. In France, spiramycin is usually prescribed for maternal seroconversions. A more potent pyrimethamine + sulfadiazine regimen is used to treat congenital toxoplasmosis and is offered in some countries as prophylaxis. OBJECTIVE: We sought to compare the efficacy and tolerance of pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission. STUDY DESIGN: This was a randomized, open-label trial in 36 French centers, comparing pyrimethamine (50 mg qd) + sulfadiazine (1 g tid) with folinic acid vs spiramycin (1 g tid) following toxoplasmosis seroconversion. RESULTS: In all, 143 women were randomized from November 2010 through January 2014. An amniocentesis was later performed in 131 cases, with a positive Toxoplasma gondii polymerase chain reaction in 7/67 (10.4%) in the pyrimethamine + sulfadiazine group vs 13/64 (20.3%) in the spiramycin group. Cerebral ultrasound anomalies appeared in 0/73 fetuses in the pyrimethamine + sulfadiazine group, vs 6/70 in the spiramycin group (P = .01). Two of these pregnancies were terminated. Transmission rates, excluding 18 children with undefined status, were 12/65 in the pyrimethamine + sulfadiazine group (18.5%), vs 18/60 in the spiramycin group (30%, P = .147), equivalent to an odds ratio of 0.53 (95% confidence interval, 0.23-1.22) and which after adjustment tended to be stronger (P = .03 for interaction) when treatment started within 3 weeks of seroconversion (95% confidence interval, 0.00-1.63). Two women had severe rashes, both with pyrimethamine + sulfadiazine. CONCLUSION: There was a trend toward lower transmission with pyrimethamine + sulfadiazine, but it did not reach statistical significance, possibly for lack of statistical power because enrollment was discontinued. There were also no fetal cerebral toxoplasmosis lesions in the pyrimethamine + sulfadiazine group. These promising results encourage further research on chemoprophylaxis to prevent congenital toxoplasmosis.
dc.language.isoENen_US
dc.subject.enSISTM
dc.title.enPrenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial
dc.title.alternativeAm J Obstet Gynecolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.ajog.2018.05.031
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed29870736en_US
bordeaux.journalAmerican Journal of Obstetrics and Gynecologyen_US
bordeaux.page386 e1-386-e9en_US
bordeaux.volume219en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue4en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamSISTMen_US
bordeaux.teamSISTM_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03161817
hal.version1
hal.date.transferred2021-03-08T08:55:07Z
hal.exporttrue
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