Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine for the Prevention of Malaria During Pregnancy in Mali: A Randomized Controlled Trial
Background. In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women u...
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| Veröffentlicht in: | Clinical infectious diseases 2011-08, Vol.53 (3), p.215-223 |
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| creator | Maiga, Oumou M. Kayentao, Kassoum Traoré, Boubacar T. Djimde, Abdoulaye Traoré, Bouyagui Diallo, Mouctar Ongoiba, Aissata Doumtabé, Didier Doumbo, Safiatou Traoré, Mamadou S. Dara, Antoine Guindo, Oumar Karim, Diawara M. Coulibaly, Siraman Bougoudogo, Flabou Kuile, Feiko O. ter Danis, Martin Doumbo, Ogobara K. |
| description | Background. In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW). Methods. We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints. Results. Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32—0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32—0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19—0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed. Conclusions. Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance. Clinical Trials Registration. ISRCTN 74189211. |
| doi_str_mv | 10.1093/cid/cir374 |
| format | Article |
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In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW). Methods. We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints. Results. Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32—0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32—0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19—0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed. Conclusions. Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance. Clinical Trials Registration. ISRCTN 74189211.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/cir374</identifier><identifier>PMID: 21765069</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject><![CDATA[Academic progress rate ; Adolescent ; Adult ; Anemia ; Anemia - prevention & control ; Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antimalarials - administration & dosage ; Antimalarials - adverse effects ; Antiparasitic agents ; ARTICLES AND COMMENTARIES ; Biological and medical sciences ; Birth weight ; Blood ; Chemoprevention - adverse effects ; Chemoprevention - methods ; Clinical trials ; Disease prevention ; Dosage ; Drug Combinations ; Drug dosages ; Experimentation ; Female ; Hemoglobins ; Human protozoal diseases ; Humans ; Infant, Low Birth Weight ; Infant, Newborn ; Infectious diseases ; Jaundice, Neonatal - prevention & control ; Low birth weight ; Malaria ; Malaria - prevention & control ; Mali ; Medical sciences ; Middle Aged ; Parasitic diseases ; Pharmacology. Drug treatments ; Pregnancy ; Pregnancy Complications, Infectious - prevention & control ; Premature Birth - prevention & control ; Protozoal diseases ; Pyrimethamine - administration & dosage ; Pyrimethamine - adverse effects ; Skin Diseases - chemically induced ; Sulfadoxine - administration & dosage ; Sulfadoxine - adverse effects ; Treatment Outcome ; Young Adult]]></subject><ispartof>Clinical infectious diseases, 2011-08, Vol.53 (3), p.215-223</ispartof><rights>Copyright © 2011 Oxford University Press on behalf of the Infectious Diseases Society of America</rights><rights>The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. 2011</rights><rights>2015 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Aug 1, 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-20ac2f1f22eb190852d3c0631bb89b75263c24998d670e4540b959f34246f8bc3</citedby><cites>FETCH-LOGICAL-c464t-20ac2f1f22eb190852d3c0631bb89b75263c24998d670e4540b959f34246f8bc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/23053195$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/23053195$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,776,780,799,1578,27901,27902,57992,58225</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24462150$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21765069$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maiga, Oumou M.</creatorcontrib><creatorcontrib>Kayentao, Kassoum</creatorcontrib><creatorcontrib>Traoré, Boubacar T.</creatorcontrib><creatorcontrib>Djimde, Abdoulaye</creatorcontrib><creatorcontrib>Traoré, Bouyagui</creatorcontrib><creatorcontrib>Diallo, Mouctar</creatorcontrib><creatorcontrib>Ongoiba, Aissata</creatorcontrib><creatorcontrib>Doumtabé, Didier</creatorcontrib><creatorcontrib>Doumbo, Safiatou</creatorcontrib><creatorcontrib>Traoré, Mamadou S.</creatorcontrib><creatorcontrib>Dara, Antoine</creatorcontrib><creatorcontrib>Guindo, Oumar</creatorcontrib><creatorcontrib>Karim, Diawara M.</creatorcontrib><creatorcontrib>Coulibaly, Siraman</creatorcontrib><creatorcontrib>Bougoudogo, Flabou</creatorcontrib><creatorcontrib>Kuile, Feiko O. ter</creatorcontrib><creatorcontrib>Danis, Martin</creatorcontrib><creatorcontrib>Doumbo, Ogobara K.</creatorcontrib><title>Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine for the Prevention of Malaria During Pregnancy in Mali: A Randomized Controlled Trial</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>Background. In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW). Methods. We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints. Results. Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32—0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32—0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19—0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed. Conclusions. Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance. Clinical Trials Registration. ISRCTN 74189211.</description><subject>Academic progress rate</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Anemia</subject><subject>Anemia - prevention & control</subject><subject>Antibacterial agents</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antimalarials - administration & dosage</subject><subject>Antimalarials - adverse effects</subject><subject>Antiparasitic agents</subject><subject>ARTICLES AND COMMENTARIES</subject><subject>Biological and medical sciences</subject><subject>Birth weight</subject><subject>Blood</subject><subject>Chemoprevention - adverse effects</subject><subject>Chemoprevention - methods</subject><subject>Clinical trials</subject><subject>Disease prevention</subject><subject>Dosage</subject><subject>Drug Combinations</subject><subject>Drug dosages</subject><subject>Experimentation</subject><subject>Female</subject><subject>Hemoglobins</subject><subject>Human protozoal diseases</subject><subject>Humans</subject><subject>Infant, Low Birth Weight</subject><subject>Infant, Newborn</subject><subject>Infectious diseases</subject><subject>Jaundice, Neonatal - prevention & control</subject><subject>Low birth weight</subject><subject>Malaria</subject><subject>Malaria - prevention & control</subject><subject>Mali</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Parasitic diseases</subject><subject>Pharmacology. Drug treatments</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Infectious - prevention & control</subject><subject>Premature Birth - prevention & control</subject><subject>Protozoal diseases</subject><subject>Pyrimethamine - administration & dosage</subject><subject>Pyrimethamine - adverse effects</subject><subject>Skin Diseases - chemically induced</subject><subject>Sulfadoxine - administration & dosage</subject><subject>Sulfadoxine - adverse effects</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kV1rFDEUhoMotq7eeK-EgijCaL4n413Z-lGotNgVL4fMTNLNMpOsSWZx-8f698ywaxe86EU4J-c85z0kLwAvMfqAUUU_trbLJ9CSPQLHmNOyELzCj3OOuCyYpPIIPItxhRDGEvGn4IjgUnAkqmNwdz2udbA-2LSF3kAKLzc6QALPfNRxqpy7pMNgU9IuwaugNznajYaLoFUapuIvm5bweuyN6vwf63RxtQ120GmphnyDxgeYlvp-1rtJ9rvqVbAKno3BupupeeOUa7fQuqlnP8FT-EO5zg_2Vndw7l0Kvu9zushj_XPwxKg-6hf7OAM_v3xezL8VF5dfz-enF0XLBEsFQaolBhtCdIMrJDnpaIsExU0jq6bkRNCWsKqSnSiRZpyhpuKVoYwwYWTT0hl4u9NdB_971DHVg42t7nvltB9jLUuJMi1wJt89SGJOEC0Jzitn4OQ_dOXH4PI7Jj3OJMMkQ-93UBt8jEGbep1_VYVtjVE9-V5n3-ud7xl-vVccm0F39-g_ozPwZg-o2KrehPzXNh44xgTBHB04P64fXvhqx61i8uGgQxGnuOL0L-I2zVg</recordid><startdate>20110801</startdate><enddate>20110801</enddate><creator>Maiga, Oumou M.</creator><creator>Kayentao, Kassoum</creator><creator>Traoré, Boubacar T.</creator><creator>Djimde, Abdoulaye</creator><creator>Traoré, Bouyagui</creator><creator>Diallo, Mouctar</creator><creator>Ongoiba, Aissata</creator><creator>Doumtabé, Didier</creator><creator>Doumbo, Safiatou</creator><creator>Traoré, Mamadou S.</creator><creator>Dara, Antoine</creator><creator>Guindo, Oumar</creator><creator>Karim, Diawara M.</creator><creator>Coulibaly, Siraman</creator><creator>Bougoudogo, Flabou</creator><creator>Kuile, Feiko O. ter</creator><creator>Danis, Martin</creator><creator>Doumbo, Ogobara K.</creator><general>Oxford University Press</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>F1W</scope><scope>H95</scope><scope>H97</scope><scope>L.G</scope><scope>7X8</scope></search><sort><creationdate>20110801</creationdate><title>Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine for the Prevention of Malaria During Pregnancy in Mali: A Randomized Controlled Trial</title><author>Maiga, Oumou M. ; Kayentao, Kassoum ; Traoré, Boubacar T. ; Djimde, Abdoulaye ; Traoré, Bouyagui ; Diallo, Mouctar ; Ongoiba, Aissata ; Doumtabé, Didier ; Doumbo, Safiatou ; Traoré, Mamadou S. ; Dara, Antoine ; Guindo, Oumar ; Karim, Diawara M. ; Coulibaly, Siraman ; Bougoudogo, Flabou ; Kuile, Feiko O. ter ; Danis, Martin ; Doumbo, Ogobara K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-20ac2f1f22eb190852d3c0631bb89b75263c24998d670e4540b959f34246f8bc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Academic progress rate</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Anemia</topic><topic>Anemia - prevention & control</topic><topic>Antibacterial agents</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antimalarials - administration & dosage</topic><topic>Antimalarials - adverse effects</topic><topic>Antiparasitic agents</topic><topic>ARTICLES AND COMMENTARIES</topic><topic>Biological and medical sciences</topic><topic>Birth weight</topic><topic>Blood</topic><topic>Chemoprevention - adverse effects</topic><topic>Chemoprevention - methods</topic><topic>Clinical trials</topic><topic>Disease prevention</topic><topic>Dosage</topic><topic>Drug Combinations</topic><topic>Drug dosages</topic><topic>Experimentation</topic><topic>Female</topic><topic>Hemoglobins</topic><topic>Human protozoal diseases</topic><topic>Humans</topic><topic>Infant, Low Birth Weight</topic><topic>Infant, Newborn</topic><topic>Infectious diseases</topic><topic>Jaundice, Neonatal - prevention & control</topic><topic>Low birth weight</topic><topic>Malaria</topic><topic>Malaria - prevention & control</topic><topic>Mali</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Parasitic diseases</topic><topic>Pharmacology. Drug treatments</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Infectious - prevention & control</topic><topic>Premature Birth - prevention & control</topic><topic>Protozoal diseases</topic><topic>Pyrimethamine - administration & dosage</topic><topic>Pyrimethamine - adverse effects</topic><topic>Skin Diseases - chemically induced</topic><topic>Sulfadoxine - administration & dosage</topic><topic>Sulfadoxine - adverse effects</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maiga, Oumou M.</creatorcontrib><creatorcontrib>Kayentao, Kassoum</creatorcontrib><creatorcontrib>Traoré, Boubacar T.</creatorcontrib><creatorcontrib>Djimde, Abdoulaye</creatorcontrib><creatorcontrib>Traoré, Bouyagui</creatorcontrib><creatorcontrib>Diallo, Mouctar</creatorcontrib><creatorcontrib>Ongoiba, Aissata</creatorcontrib><creatorcontrib>Doumtabé, Didier</creatorcontrib><creatorcontrib>Doumbo, Safiatou</creatorcontrib><creatorcontrib>Traoré, Mamadou S.</creatorcontrib><creatorcontrib>Dara, Antoine</creatorcontrib><creatorcontrib>Guindo, Oumar</creatorcontrib><creatorcontrib>Karim, Diawara M.</creatorcontrib><creatorcontrib>Coulibaly, Siraman</creatorcontrib><creatorcontrib>Bougoudogo, Flabou</creatorcontrib><creatorcontrib>Kuile, Feiko O. ter</creatorcontrib><creatorcontrib>Danis, Martin</creatorcontrib><creatorcontrib>Doumbo, Ogobara K.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ASFA: Aquatic Sciences and Fisheries Abstracts</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 1: Biological Sciences & Living Resources</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 3: Aquatic Pollution & Environmental Quality</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) Professional</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maiga, Oumou M.</au><au>Kayentao, Kassoum</au><au>Traoré, Boubacar T.</au><au>Djimde, Abdoulaye</au><au>Traoré, Bouyagui</au><au>Diallo, Mouctar</au><au>Ongoiba, Aissata</au><au>Doumtabé, Didier</au><au>Doumbo, Safiatou</au><au>Traoré, Mamadou S.</au><au>Dara, Antoine</au><au>Guindo, Oumar</au><au>Karim, Diawara M.</au><au>Coulibaly, Siraman</au><au>Bougoudogo, Flabou</au><au>Kuile, Feiko O. ter</au><au>Danis, Martin</au><au>Doumbo, Ogobara K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine for the Prevention of Malaria During Pregnancy in Mali: A Randomized Controlled Trial</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2011-08-01</date><risdate>2011</risdate><volume>53</volume><issue>3</issue><spage>215</spage><epage>223</epage><pages>215-223</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><abstract>Background. In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW). Methods. We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints. Results. Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32—0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32—0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19—0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed. Conclusions. Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance. Clinical Trials Registration. ISRCTN 74189211.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>21765069</pmid><doi>10.1093/cid/cir374</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1058-4838 |
| ispartof | Clinical infectious diseases, 2011-08, Vol.53 (3), p.215-223 |
| issn | 1058-4838 1537-6591 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_878034261 |
| source | Jstor Complete Legacy; Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Academic progress rate Adolescent Adult Anemia Anemia - prevention & control Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Antimalarials - administration & dosage Antimalarials - adverse effects Antiparasitic agents ARTICLES AND COMMENTARIES Biological and medical sciences Birth weight Blood Chemoprevention - adverse effects Chemoprevention - methods Clinical trials Disease prevention Dosage Drug Combinations Drug dosages Experimentation Female Hemoglobins Human protozoal diseases Humans Infant, Low Birth Weight Infant, Newborn Infectious diseases Jaundice, Neonatal - prevention & control Low birth weight Malaria Malaria - prevention & control Mali Medical sciences Middle Aged Parasitic diseases Pharmacology. Drug treatments Pregnancy Pregnancy Complications, Infectious - prevention & control Premature Birth - prevention & control Protozoal diseases Pyrimethamine - administration & dosage Pyrimethamine - adverse effects Skin Diseases - chemically induced Sulfadoxine - administration & dosage Sulfadoxine - adverse effects Treatment Outcome Young Adult |
| title | Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine for the Prevention of Malaria During Pregnancy in Mali: A Randomized Controlled Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-10T10%3A57%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-jstor_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Superiority%20of%203%20Over%202%20Doses%20of%20Intermittent%20Preventive%20Treatment%20With%20Sulfadoxine-Pyrimethamine%20for%20the%20Prevention%20of%20Malaria%20During%20Pregnancy%20in%20Mali:%20A%20Randomized%20Controlled%20Trial&rft.jtitle=Clinical%20infectious%20diseases&rft.au=Maiga,%20Oumou%20M.&rft.date=2011-08-01&rft.volume=53&rft.issue=3&rft.spage=215&rft.epage=223&rft.pages=215-223&rft.issn=1058-4838&rft.eissn=1537-6591&rft.coden=CIDIEL&rft_id=info:doi/10.1093/cid/cir374&rft_dat=%3Cjstor_proqu%3E23053195%3C/jstor_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=878548412&rft_id=info:pmid/21765069&rft_jstor_id=23053195&rft_oup_id=10.1093/cid/cir374&rfr_iscdi=true |