search
Back to results

IPTp Plus ITNs for Malaria Control in Pregnant Women

Primary Purpose

Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Sulfadoxine-Pyrimethamine (Fansidar)
ITNs
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Less than 28 weeks of pregnancy Exclusion Criteria: Previous allergic reactions to sulphonamides

Sites / Locations

  • Centro de Investigaçao em Saude da Manhiça

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
Maternal anaemia at and after delivery
Parasite prevalence at and after delivery
Placental malaria infection
Infant mortality and morbidity
Gestational age of the newborn
Child parasitaemia and anaemia 12 months after delivery
To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
To evaluate the cost-effectiveness of the interventions
To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
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

Full Information

First Posted
September 13, 2005
Last Updated
February 29, 2008
Sponsor
Hospital Clinic of Barcelona
search

1. Study Identification

Unique Protocol Identification Number
NCT00209781
Brief Title
IPTp Plus ITNs for Malaria Control in Pregnant Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

5. Study Description

Brief Summary
We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1028 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-Pyrimethamine (Fansidar)
Intervention Type
Device
Intervention Name(s)
ITNs
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
Title
Maternal anaemia at and after delivery
Title
Parasite prevalence at and after delivery
Title
Placental malaria infection
Title
Infant mortality and morbidity
Title
Gestational age of the newborn
Title
Child parasitaemia and anaemia 12 months after delivery
Title
To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
Title
To evaluate the cost-effectiveness of the interventions
Title
To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
Title
To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Less than 28 weeks of pregnancy Exclusion Criteria: Previous allergic reactions to sulphonamides
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Menendez, MD, PhD
Organizational Affiliation
Centre for International Health, Hospital Clinic de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigaçao em Saude da Manhiça
City
Manhiça
State/Province
Maputo
Country
Mozambique

12. IPD Sharing Statement

Citations:
PubMed Identifier
22447794
Citation
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.
Results Reference
derived
PubMed Identifier
21199881
Citation
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.
Results Reference
derived
PubMed Identifier
20976217
Citation
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.
Results Reference
derived
PubMed Identifier
20195472
Citation
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.
Results Reference
derived
PubMed Identifier
19954383
Citation
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.
Results Reference
derived
PubMed Identifier
18651857
Citation
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.
Results Reference
derived
PubMed Identifier
18398460
Citation
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.
Results Reference
derived

Learn more about this trial

IPTp Plus ITNs for Malaria Control in Pregnant Women

We'll reach out to this number within 24 hrs