- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00209781
IPTp Plus ITNs for Malaria Control in Pregnant Women
Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Pregnant women are at an increased risk for malaria infection and disease. Maternal anaemia, low birth weight and prematurity are the most frequent adverse effects of the infection. The current WHO recommendation consists on the provision of insecticide treated nets (ITN's) and intermittent preventive treatment (IPT). Results from a recentn trial of ITN's have shown a significant reduction in maternal anaemia, parasitaemia and low birth weight prevalence in women sleeping under impregnated nets. However, scarce information exists on the relative efficacy of IPT and ITNs to reduce the deleterious effects of malaria infection during pregnancy when given at the same time. This information is of relevance to guide national malaria control programmes.
This study consists on the administration of two double blind doses of IPT with Sulfadoxine-Pyrimethamine or placebo at predefined intervals, after the beginning of the second trimester. All women receive an ITN.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maputo
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Manhiça, Maputo, Mozambique
- Centro de Investigação em Saude da Manhiça
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Less than 28 weeks of pregnancy
Exclusion Criteria:
- Previous allergic reactions to sulphonamides
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
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Sekundære resultatmål
Resultatmål |
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To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
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Maternal anaemia at and after delivery
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Parasite prevalence at and after delivery
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Placental malaria infection
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Infant mortality and morbidity
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Gestational age of the newborn
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Child parasitaemia and anaemia 12 months after delivery
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To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
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To evaluate the cost-effectiveness of the interventions
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To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
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To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
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To asses the effect of IPT with SP in HIV positive pregnant women on the prevention of mother-to-child HIV transmission and on the viral load reduction in the mother
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Clara Menendez, MD, PhD, Centre for International Health, Hospital Clinic de Barcelona
Publikationer og nyttige links
Generelle publikationer
- Mayor A, Moro L, Aguilar R, Bardaji A, Cistero P, Serra-Casas E, Sigauque B, Alonso PL, Ordi J, Menendez C. How hidden can malaria be in pregnant women? Diagnosis by microscopy, placental histology, polymerase chain reaction and detection of histidine-rich protein 2 in plasma. Clin Infect Dis. 2012 Jun;54(11):1561-8. doi: 10.1093/cid/cis236. Epub 2012 Mar 23.
- Bardaji A, Sigauque B, Sanz S, Maixenchs M, Ordi J, Aponte JJ, Mabunda S, Alonso PL, Menendez C. Impact of malaria at the end of pregnancy on infant mortality and morbidity. J Infect Dis. 2011 Mar 1;203(5):691-9. doi: 10.1093/infdis/jiq049. Epub 2011 Jan 3.
- Sicuri E, Bardaji A, Nhampossa T, Maixenchs M, Nhacolo A, Nhalungo D, Alonso PL, Menendez C. Cost-effectiveness of intermittent preventive treatment of malaria in pregnancy in southern Mozambique. PLoS One. 2010 Oct 15;5(10):e13407. doi: 10.1371/journal.pone.0013407.
- Menendez C, Bardaji A, Sigauque B, Sanz S, Aponte JJ, Mabunda S, Alonso PL. Malaria prevention with IPTp during pregnancy reduces neonatal mortality. PLoS One. 2010 Feb 26;5(2):e9438. doi: 10.1371/journal.pone.0009438.
- Serra-Casas E, Menendez C, Bardaji A, Quinto L, Dobano C, Sigauque B, Jimenez A, Mandomando I, Chauhan VS, Chitnis CE, Alonso PL, Mayor A. The effect of intermittent preventive treatment during pregnancy on malarial antibodies depends on HIV status and is not associated with poor delivery outcomes. J Infect Dis. 2010 Jan 1;201(1):123-31. doi: 10.1086/648595.
- Naniche D, Lahuerta M, Bardaji A, Sigauque B, Romagosa C, Berenguera A, Mandomando I, David C, Sanz S, Aponte J, Ordi J, Alonso P, Menendez C. Mother-to-child transmission of HIV-1: association with malaria prevention, anaemia and placental malaria. HIV Med. 2008 Oct;9(9):757-64. doi: 10.1111/j.1468-1293.2008.00626.x. Epub 2008 Jul 19.
- Menendez C, Bardaji A, Sigauque B, Romagosa C, Sanz S, Serra-Casas E, Macete E, Berenguera A, David C, Dobano C, Naniche D, Mayor A, Ordi J, Mandomando I, Aponte JJ, Mabunda S, Alonso PL. A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic. PLoS One. 2008 Apr 9;3(4):e1934. doi: 10.1371/journal.pone.0001934.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Vektorbårne sygdomme
- Parasitiske sygdomme
- Protozoiske infektioner
- Malaria
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Antiprotozoale midler
- Antiparasitære midler
- Antimalariamidler
- Folinsyreantagonister
- Anti-infektionsmidler, urinveje
- Nyremidler
- Pyrimethamin
- Sulfadoxin
- Fanasil, pyrimethamin lægemiddel kombination
Andre undersøgelses-id-numre
- TimNet
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
Kliniske forsøg med Sulfadoxin-Pyrimethamin (Fansidar)
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Center for International Health and DevelopmentCenters for Disease Control and PreventionAfsluttetHIV-infektioner | Præmaturitet | Dødfødsel | Neonatale dødsfald | Placental Malaria InfectionZambia
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Hospital Clinic of BarcelonaUkendt
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Bandim Health ProjectAfsluttet
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National Institute of Allergy and Infectious Diseases...AfsluttetAutoimmun sygdom | Lymfoproliferativ lidelseForenede Stater
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University of California, San FranciscoCenters for Disease Control and Prevention; Uganda Malaria Surveillance...Trukket tilbageIntermitterende forebyggende behandling | Placental malariaUganda
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ORIYOMI OMOTOYOSI AKINYOTUUniversity of IbadanAfsluttetMalaria hos gravide HIV+-patienterNigeria
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Institute of Tropical Medicine, BelgiumAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Liverpool... og andre samarbejdspartnereAfsluttetMalaria under graviditetBurkina Faso
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Swiss Tropical & Public Health InstituteLondon School of Hygiene and Tropical Medicine; Hospital Clinic of Barcelona og andre samarbejdspartnereUkendt
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London School of Hygiene and Tropical MedicineNational Institute for Medical Research, Tanzania; Kilimanjaro Christian...AfsluttetMalaria | Kardiotoksicitet | Parasitæmi | Graviditet Malaria | HjertesikkerhedTanzania
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Emzor Pharmaceutical Industries LimitedIkke rekrutterer endnu