| Title: |
Prenatal therapy with pyrimethamine + sulfadiazine vs spiramycin to reduce placental transmission of toxoplasmosis: a multicenter, randomized trial ; Am J Obstet Gynecol |
| Authors: |
MANDELBROT, L.; KIEFFER, F.; SITTA, R.; LAURICHESSE-DELMAS, H.; WINER, N.; MESNARD, L.; BERREBI, A.; LE BOUAR, G.; BORY, J. P.; CORDIER, A. G.; VILLE, Y.; PERROTIN, F.; JOUANNIC, J. M.; BIQUARD, F.; D'ERCOLE, C.; HOUFFLIN-DEBARGE, V.; VILLENA, I.; THIEBAUT, Rodolphe |
| Publication Year: |
2018 |
| Subject Terms: |
SISTM; Sciences du Vivant [q-bio]/Santé publique et épidémiologie |
| Description: |
BACKGROUND: 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1016/j.ajog.2018.05.031 |
| Availability: |
https://oskar-bordeaux.fr/handle/20.500.12278/21306; https://hdl.handle.net/20.500.12278/21306; https://doi.org/10.1016/j.ajog.2018.05.031 |
| Rights: |
open |
| Accession Number: |
edsbas.BCC1D10C |
| Database: |
BASE |