IPTp Plus ITNs for Malaria Control in Pregnant Women

NCT ID: NCT00209781

Last Updated: 2008-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1028 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Sulfadoxine-Pyrimethamine (Fansidar)

Intervention Type DRUG

ITNs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Less than 28 weeks of pregnancy

Exclusion Criteria

* Previous allergic reactions to sulphonamides
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Principal Investigators

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Clara Menendez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for International Health, Hospital Clinic de Barcelona

Locations

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Centro de Investigaçao em Saude da Manhiça

Manhiça, Maputo Province, Mozambique

Site Status

Countries

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Mozambique

References

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Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

Reference Type DERIVED
PMID: 39324693 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22447794 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21199881 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20976217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20195472 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19954383 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18651857 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18398460 (View on PubMed)

Related Links

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Other Identifiers

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TimNet

Identifier Type: -

Identifier Source: org_study_id

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