NCT00209781

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,028

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 6, 2008

Status Verified

February 1, 2008

First QC Date

September 13, 2005

Last Update Submit

February 29, 2008

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Interventions

Sulfadoxine-Pyrimethamine (Fansidar)DRUG
ITNsDEVICE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Less than 28 weeks of pregnancy

You may not qualify if:

  • Previous allergic reactions to sulphonamides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigaçao em Saude da Manhiça

Manhiça, Maputo Province, Mozambique

Location

Related Publications (8)

  • 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.

    PMID: 39324693DERIVED

  • 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.

    PMID: 22447794DERIVED

  • 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.

    PMID: 21199881DERIVED

  • 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.

    PMID: 20976217DERIVED

  • 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.

    PMID: 20195472DERIVED

  • 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.

    PMID: 19954383DERIVED

  • 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.

    PMID: 18651857DERIVED

  • 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.

    PMID: 18398460DERIVED

Related Links

MeSH Terms

Interventions

fanasil, pyrimethamine drug combination

Study Officials

  • Clara Menendez, MD, PhD

    Centre for International Health, Hospital Clinic de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2003

Study Completion

December 1, 2006

Last Updated

March 6, 2008

Record last verified: 2008-02

Locations

MO(1)