Intermittent Preventive Treatment During Pregnancy in Benin

October 30, 2008 updated by: Institut de Recherche pour le Developpement

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
      • Cotonou, Benin, 01 BP 4414 RP
        • Institut de Recherche pour le Developpement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
proportion of infants with low birthweight (<2,500 grams)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche pour le Developpement

Collaborators

National Malaria Control Program, Benin
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 10, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 30, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR10_01_2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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