Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

30. januar 2006 opdateret af: Center for International Health and Development

Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in HIV-Seropositive and HIV-Seronegative Pregnant Women in Zambia

Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary Objectives

To compare the efficacy of IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on the:

  • Prevalence of placental malaria infection
  • Prevalence of maternal peripheral parasitemia

Secondary objectives

To compare IPT with monthly SP versus a two-dose regimen given once in the second and once in the third trimester in HIV-infected women on:

  • Birth weight, including the proportion of LBW infants
  • Incidence of prematurity
  • Neonatal and fetal death and third trimester stillbirth
  • Incidence of neonatal jaundice
  • Third trimester anemia
  • Third trimester severe anemia
  • Proportion of mothers who develop symptomatic malaria during the course of pregnancy

Undersøgelsestype

Interventionel

Tilmelding

454

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Zambia
      • Ndola, Zambia
        • Tropical Diseases Research Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • HIV-positive pregnant women between 16-28 weeks of gestation identified through VCT
  • HIV-negative pregnant women between 16-28 weeks of gestation identified through VCT
  • Residence within the catchment area of the health facility
  • Willing to deliver at the health facility
  • Willing to agree to adhere to the requirements of study participation (including monthly ANC visits and willing to allow all study procedures)
  • Willing to provide written informed consent
  • Aged 18 years and above

Exclusion Criteria:

  • Severe anemia (Hb < 6 g/dL)
  • History of allergic reactions to sulfa drugs
  • History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section)
  • History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization
  • Any significant presenting illness that requires hospitalization
  • Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area
  • Prior enrollment in the study or concurrent enrollment in another study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
• Prevalence of placental malaria infection
• Prevalence of maternal peripheral parasitemia

Sekundære resultatmål

Resultatmål
• Prevalence of maternal peripheral parasitemia
• Birth weight, including the proportion of LBW infants
• Incidence of prematurity
• Neonatal and fetal death and third trimester stillbirth
• Incidence of neonatal jaundice
• Third trimester anemia
• Third trimester severe anemia
• Proportion of mothers who develop symptomatic malaria during the course of pregnancy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Center for International Health and Development

Samarbejdspartnere

Centers for Disease Control and Prevention

Efterforskere

  • Ledende efterforsker: Davidson H Hamer, MD, Center for International Health and Development, Boston University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2002

Studieafslutning

1. oktober 2004

Datoer for studieregistrering

Først indsendt

23. december 2005

Først indsendt, der opfyldte QC-kriterier

23. december 2005

Først opslået (Skøn)

28. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2006

Sidst verificeret

1. november 2004

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S1954-21/22-2

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner