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PregnancyNCT00209781

IPTp Plus ITNs for Malaria Control in Pregnant Women

A study testing Sulfadoxine-Pyrimethamine (Fansidar) and ITNs in people with Pregnancy, run by Hospital Clinic of Barcelona at 1 site in Mozambique.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Sulfadoxine-Pyrimethamine (Fansidar) and ITNs
Type of treatment
Medical device
How many people
1,028 participants
Where
1 siteMozambique
Study dates
Aug 2003to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Less than 28 weeks of pregnancy

Who cannot join

  • Previous allergic reactions to sulphonamides

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Centro de Investigaçao em Saude da Manhiça

    Manhiça, Maputo Province

Other trials in Mozambique

About this study

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

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

Read the 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.

Conditions
Pregnancy
Being tested
Sulfadoxine-Pyrimethamine (Fansidar), ITNs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulfadoxine-Pyrimethamine (Fansidar)Drug

  • ITNsDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:

  2. Maternal anaemia at and after delivery

  3. Parasite prevalence at and after delivery

  4. Placental malaria infection

  5. Infant mortality and morbidity

  6. Gestational age of the newborn

  7. Child parasitaemia and anaemia 12 months after delivery

  8. To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women

  9. To evaluate the cost-effectiveness of the interventions

  10. To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes

  11. To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy

  12. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startAug 2003
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,028 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209781
Sponsor's protocol ID
TimNet
Status last verified
Feb 2008
First submitted
13 Sep 2005
Last updated
6 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 39324693

  • 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.

    PubMed 22447794

  • 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.

    PubMed 21199881

  • 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.

    PubMed 20976217

  • 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.

    PubMed 20195472

  • 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.

    PubMed 19954383

  • 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.

    PubMed 18651857

  • 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.

    PubMed 18398460

Questions about this trial

What is this clinical trial studying?

A study testing Sulfadoxine-Pyrimethamine (Fansidar) and ITNs in people with Pregnancy, run by Hospital Clinic of Barcelona at 1 site in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00209781, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2008.

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