Intermittent Preventive Treatment During Pregnancy in Benin

Sponsor

Institut de Recherche pour le Developpement (Other)

Overall Status

Completed

CT.gov ID

NCT00274235

Collaborator

National Malaria Control Program, Benin (Other), Ministry of Foreign Affairs, France (Other), Institut des Sciences Biomédicales Appliquées, Bénin (Other), Faculté des Sciences de la Santé, Bénin (Other)

1,600

Enrollment

Location

Duration (Months)

48.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: sulfadoxine-pyrimethamine / mefloquine	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

proportion of infants with low birthweight (<2,500 grams) []

Secondary Outcome Measures

mean birthweight []
proportion of mothers with placental plasmodial infection []
proportion of preterm deliveries []
proportion of mothers with anaemia (Haemoglobin level (Hb)<11g/dl) and severe anaemia (Hb<8g/dl) at delivery []
proportion of mothers with parasitaemia at delivery []
proportion of adverse events after taking study drugs []
proportion of congenital abnormalities []
proportion of stillbirths []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)