New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa

NCT00730366 | Completed Phase 3

• 1 other identifier: DELIMAL
• Study Type: interventional
• Target: 2,766
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight: effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000 infant deaths every year. Intermittent preventive treatment with the drug sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal clinics, is recommended by the World Health Organization for areas of moderate to high malaria transmission, including Sub-Saharan Africa. Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight. However, in countries where this strategy had been introduced as part of national policy, the coverage of the target population has varied widely, with estimates of 33-93% for uptake of one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage were therefore urgently needed. This study was therefore set up in 2002, in order to evaluate the additional effect of a targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.

Conditions

Malaria in Pregnancy

Keywords

Malaria; Pregnancy; Intermittent Preventive Treatment

Outcome Measures

Primary Outcomes (1)

• Birth weight

  At delivery

Secondary Outcomes (3)

• Anemia

  At 32 weeks gestation and at delivery

• Peripheral and placental parasitaemia

  At 32 weeks gestation (peripheral) and at delivery (both)

• Gestational age

  At first antenatal visit

Study Arms (3)

1

EXPERIMENTAL

Experimental: IPTp-SP + promotion: Active Comparator

Drug: sulfadoxine-pyrimethamine

2

EXPERIMENTAL

IPTp-SP alone (without promotion)

Drug: sulfadoxine-pyrimethamine

3

ACTIVE COMPARATOR

Weekly CQ prophylaxis

Drug: Chloroquine

Interventions

sulfadoxine-pyrimethamine DRUG

Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy

Also known as: IPTp-SP, SP, Fansidar

1; 2

Chloroquine DRUG

Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week

Also known as: CQ, Nivaquine

3

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• First or second trimester of pregnancy
• First or second pregnancy
• Resident in the study area

You may not qualify if:

• \- Refuse to give informed consent

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Ouagadougou, Burkina Faso: collaborator
• National Laboratory of Public Health,Burkina Faso: collaborator
• Liverpool School of Tropical Medicine: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

District Sanitaire

Boromo, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Chloroquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sheick Coulibaly Oumar Coulibaly, MD PhD

  Directeur de la Biologie Médicale du Laboratoire National de Santé Publique

  STUDY DIRECTOR

• Umberto D'Alessandro, MD

  Institute of Tropical Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: March 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: December 1, 2006
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BU (1)