Intermittent Preventive Treatment During Pregnancy in Benin

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-04-30

Brief Summary

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Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.

Detailed Description

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The trial will be conducted in two maternity clinics in Ouidah, 40km from Cotonou. A total of 1600 women will be selected and randomised to receive either SP (1500 mg sulfadoxine with 75 mg pyrimethamine) or MQ (15 mg/kg) twice during pregnancy at ante-natal clinic (ANC) visits. The first dose will be given between 16 and 28 weeks of gestation, the second between 30 and 36 weeks, and at least one month after the first dose. Women will be visited at home within one week after the initial and subsequent ANC visits to check for adverse reactions due to the study drugs. Peripheral blood samples will be collected on each ANC visit to assess for haemoglobin level and parasitemia. Peripheral, placental, and cord blood samples will be collected at delivery for haematological determinations and parasitological examination. Birthweight will be recorded and the gestational age assessed by the Ballard method. The mother and her child will be assessed for general health status six weeks after birth.

Conditions

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Malaria

Keywords

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Malaria Prevention Pregnancy Low birthweight Anemia Africa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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sulfadoxine-pyrimethamine / mefloquine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnancy between 16 and 28 weeks of gestation
* Residence near the maternity clinics
* Intention to continue the ante-natal care and deliver at the study maternity clinic
* Ability to take drugs by oral route
* Written informed consent (parents or guardian if aged \< 18 years)

Exclusion Criteria

* Pregnancy prior to 16 weeks or after 28 weeks of gestation
* Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine
* History of neurological or psychiatric event
* Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment
* Current treatment with halofantrine

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Michel Cot, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherche pour le Developpement

Locations

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Institut de Recherche pour le Développement

Cotonou, , Benin

Site Status

Countries

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Benin

References

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Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis. 2009 Sep 15;200(6):991-1001. doi: 10.1086/605474.

Reference Type DERIVED

PMID: 19656069 (View on PubMed)

Briand V, Denoeud L, Massougbodji A, Cot M. Efficacy of intermittent preventive treatment versus chloroquine prophylaxis to prevent malaria during pregnancy in Benin. J Infect Dis. 2008 Aug 15;198(4):594-601. doi: 10.1086/590114.

Reference Type DERIVED

PMID: 18598190 (View on PubMed)

Other Identifiers

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UR10_01_2005

Identifier Type: -

Identifier Source: org_study_id