@article{PAR00004057, title = {{I}ntermittent treatment for the prevention of malaria during pregnancy in {B}enin : a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine}, author = {{B}riand, {V}al{\'e}rie and {B}ottero, {J}. and {N}o{\¨e}l, {H}. and {M}asse, {V}. and {C}ordel, {H}. and {G}uerra, {J}. and {K}ossou, {H}. and {F}ayomi, {B}. and {A}yemonna, {P}. and {F}ievet, {N}adine and {M}assougbodji, {A}. and {C}ot, {M}ichel}, editor = {}, language = {{ENG}}, abstract = {{B}ackground. {I}n the context of the increasing resistance to sulfadoxine-pyrimethamine ({SP}), we evaluated the efficacy of mefloquine ({MQ}) for intermittent preventive treatment during pregnancy ({IPT}p). {M}ethods. {A} multicenter, open-label equivalence trial was conducted in {B}enin from {J}uly 2005 through {A}pril 2008. {W}omen of all gravidities were randomized to receive {SP} (1500 mg of sulfadoxine and 75 mg of pyrimethamine) or 15 mg/kg {MQ} in a single intake twice during pregnancy. {T}he primary end point was the proportion of low birth-weight ({LBW}) infants (body weight, <2500 g; equivalence margin, 5%). {R}esults. {A} total of 1601 women were randomized to receive {MQ} (n = 802) or {SP} (n = 799). {I}n the modified intention-to-treat analysis, which assessed only live singleton births, 59 (8%) of 735 women who were given {MQ} and 72 (9.8%) of 730 women who were given {SP} gave birth to {LBW} infants (difference between low birth weights in treatment groups, -1.8%; 95% confidence interval [{CI}], -4.8% to 1.1%]), establishing equivalence between the drugs. {T}he per-protocol analysis showed consistent results. {MQ} was more efficacious than {SP} in preventing placental malaria (prevalence, 1.7% vs 4.4% of women; {P} = .005), clinical malaria (incidence rate, 26 cases/10,000 person-months vs. 68 cases/10,000 person-months; {P} = .007), and maternal anemia at delivery (as defined by a hemoglobin level <10 g/d{L}) (prevalence, 16% vs 20%; marginally significant at {P} = .09). {A}dverse events (mainly vomiting, dizziness, tiredness, and nausea) were more commonly associated with the use of {MQ} (prevalence, 78% vs 32%; {P} < 10(-3)). {O}ne woman in the {MQ} group had severe neuropsychiatric symptoms. {C}onclusions. {MQ} proved to be highly efficacious-both clinically and parasitologically-for use as {IPT}p. {H}owever, its low tolerability might impair its effectiveness and requires further investigations. {C}linical {T}rials {R}egistration. {NCT}00274235.}, keywords = {}, booktitle = {}, journal = {{J}ournal of {I}nfectious {D}iseases}, volume = {200}, numero = {6}, pages = {991--1001}, ISSN = {0022-1899}, year = {2009}, DOI = {10.1086/605474}, URL = {https://www.documentation.ird.fr/hor/{PAR}00004057}, }