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

NCT ID: NCT00730366

Last Updated: 2010-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2766 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-12-31

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.

Detailed Description

Each year, about 50 million women living in malaria endemic regions become pregnant, more than half in sub-Saharan Africa. In areas of relatively stable transmission, where acquired immunity to Plasmodium falciparum limits infection and prevents severe disease in adults, women in their first and second pregnancy are the most vulnerable subjects, due to a higher risk of severe anaemia and a low birth weight (LBW) outcome, a leading cause of child mortality and poor growth and development.

Malaria in pregnancy and its adverse consequences can be prevented with suppressive antimalarial treatment or chemoprophylaxis. Weekly chloroquine (CQ) had been the basis for prevention for many years, but its application became limited over time, partly because of difficulties in coverage and compliance throughout pregnancy and partly because of increased parasite resistance to CQ in endemic areas. A new strategy for prevention based on insecticide-treated bed nets (ITNs) and use of intermittent preventive treatment in pregnancy (IPTp) was thus formulated, with IPTp being based on the administration of treatment doses of sulfadoxine-pyrimethamine (1500/75 mg; SP) to all pregnant women at pre-defined intervals and regardless of malaria infection. WHO elaborated new recommendations, based on the administration of SP two or three times at scheduled antenatal visits at least one month apart from the second trimester onwards. Evidence of the efficacy of IPTp with SP for preventing malaria infection and improving birth weight was reported from East Africa and West Africa.

However, the IPTp strategy assumes that most pregnant women attend antenatal clinics (ANC) at least twice during their pregnancy and at a time when SP can be administered under direct observation. Unfortunately, it appeared soon that late attendance to ANC and weak health services limit the effectiveness of this strategy; coverage with two or more SP doses varied widely (24-68%) and was well behind the goal of 80% proposed by the Roll Back Malaria Partnership. New approaches to increase IPTp coverage were urgently needed.

This study, conceived in 2002 and carried out between 2004 and 2006, had therefore two different components: on one side, it investigated whether promoting regular and early antenatal attendance of pregnant women through community based health education would increase coverage and uptake of IPTp; on the other side, it investigated the effectiveness of IPTp-SP compared with weekly CQ, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.

Conditions

Malaria in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Experimental: IPTp-SP + promotion: Active Comparator

Group Type: EXPERIMENTAL

sulfadoxine-pyrimethamine

Intervention Type: DRUG

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

2

IPTp-SP alone (without promotion)

Group Type: EXPERIMENTAL

sulfadoxine-pyrimethamine

Intervention Type: DRUG

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

3

Weekly CQ prophylaxis

Group Type: ACTIVE_COMPARATOR

Chloroquine

Intervention Type: DRUG

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

Interventions

sulfadoxine-pyrimethamine

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

Intervention Type: DRUG

Chloroquine

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

Intervention Type: DRUG

Other Intervention Names

IPTp-SP, SP, Fansidar; CQ, Nivaquine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Refuse to give informed consent

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Ouagadougou, Burkina Faso

OTHER

Sponsor Role: collaborator

National Laboratory of Public Health,Burkina Faso

UNKNOWN

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Institute of Tropical Medicine, Antwerp, Belgium

Principal Investigators

Sheick Coulibaly Oumar Coulibaly, MD PhD

Role: STUDY_DIRECTOR

Directeur de la Biologie Médicale du Laboratoire National de Santé Publique

Umberto D'Alessandro, MD

Role: STUDY_CHAIR

Institute of Tropical Medicine

Locations

District Sanitaire

Boromo, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

DELIMAL

Identifier Type: -

Identifier Source: org_study_id