Intermittent Preventive Treatment During Pregnancy in Benin

This study has been completed.
Sponsor:
Collaborators:
National Malaria Control Program, Benin
French Ministry of Foreign Affairs, France
Institut des Sciences Biomédicales Appliquées, Bénin
Faculté des Sciences de la Santé, Bénin
Information provided by:
Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00274235
First received: January 9, 2006
Last updated: October 30, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Malaria
Drug: sulfadoxine-pyrimethamine / mefloquine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

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

Estimated Enrollment: 1600
Study Start Date: July 2005
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274235

Locations
Benin
Institut de Recherche pour le Développement
Cotonou, Benin, 01 BP 4414 RP
Sponsors and Collaborators
Institut de Recherche pour le Developpement
National Malaria Control Program, Benin
French Ministry of Foreign Affairs, France
Institut des Sciences Biomédicales Appliquées, Bénin
Faculté des Sciences de la Santé, Bénin
Investigators
Principal Investigator: Michel Cot, MD Institut de Recherche pour le Developpement
  More Information

No publications provided by Institut de Recherche pour le Developpement

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274235     History of Changes
Other Study ID Numbers: UR10_01_2005
Study First Received: January 9, 2006
Last Updated: October 30, 2008
Health Authority: France: Research Institute for Development
Benin: National Malaria Control Program

Keywords provided by Institut de Recherche pour le Developpement:
Malaria
Prevention
Pregnancy
Low birthweight
Anemia
Africa

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Mefloquine
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 23, 2014