Intermittent Preventive Treatment During Pregnancy in Benin

Malaria Clinical Trial

Official title:

Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274235
• Other study ID #: UR10_01_2005
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: October 30, 2008
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2008
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Research Institute for DevelopmentBenin: National Malaria Control Program
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• sulfadoxine-pyrimethamine / mefloquine

Locations

Country	Name	City	State
Benin	Institut de Recherche pour le Développement	Cotonou

Sponsors (5)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Faculté des Sciences de la Santé, Bénin, Institut des Sciences Biomédicales Appliquées, Bénin, Ministry of Foreign Affairs, France, National Malaria Control Program, Benin

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of infants with low birthweight (<2,500 grams)
Secondary	mean birthweight
Secondary	proportion of mothers with placental plasmodial infection
Secondary	proportion of preterm deliveries
Secondary	proportion of mothers with anaemia (Haemoglobin level (Hb)<11g/dl) and severe anaemia (Hb<8g/dl) at delivery
Secondary	proportion of mothers with parasitaemia at delivery
Secondary	proportion of adverse events after taking study drugs
Secondary	proportion of congenital abnormalities
Secondary	proportion of stillbirths