Intermittent Preventive Treatment During Pregnancy in Benin
Information source: Institut de Recherche pour le Developpement
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: sulfadoxine-pyrimethamine / mefloquine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Institut de Recherche pour le Developpement Official(s) and/or principal investigator(s): Michel Cot, MD, Principal Investigator, Affiliation: Institut de Recherche pour le Developpement
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.
Clinical Details
Official title: Intermittent Preventive Treatment During Pregnancy in Benin: a Randomized, Open, and Equivalent Trial Comparing Sulfadoxine-Pyrimethamine With Mefloquine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: proportion of infants with low birthweight (<2,500 grams)
Secondary outcome: mean birthweightproportion 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
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Institut de Recherche pour le Développement, Cotonou 01 BP 4414 RP, Benin
Additional Information
Starting date: July 2005
Last updated: October 30, 2008
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