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

This study has been completed.
Sponsor:
Collaborators:
University of Ouagadougou, Burkina Faso
National Laboratory of Public Health,Burkina Faso
Liverpool School of Tropical Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00730366
First received: August 5, 2008
Last updated: September 12, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Malaria in Pregnancy
Drug: sulfadoxine-pyrimethamine
Drug: Chloroquine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa.

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Birth weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anemia [ Time Frame: At 32 weeks gestation and at delivery ] [ Designated as safety issue: No ]
  • Peripheral and placental parasitaemia [ Time Frame: At 32 weeks gestation (peripheral) and at delivery (both) ] [ Designated as safety issue: No ]
  • Gestational age [ Time Frame: At first antenatal visit ] [ Designated as safety issue: No ]

Enrollment: 2766
Study Start Date: March 2004
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental: IPTp-SP + promotion: Active Comparator
Drug: sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
Other Name: IPTp-SP, SP, Fansidar
Experimental: 2
IPTp-SP alone (without promotion)
Drug: sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
Other Name: IPTp-SP, SP, Fansidar
Active Comparator: 3
Weekly CQ prophylaxis
Drug: Chloroquine
Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week
Other Name: CQ, Nivaquine

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00730366

Locations
Burkina Faso
District Sanitaire
Boromo, Burkina Faso
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
University of Ouagadougou, Burkina Faso
National Laboratory of Public Health,Burkina Faso
Liverpool School of Tropical Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Study Director: Sheick Coulibaly Oumar Coulibaly, MD PhD Directeur de la Biologie Médicale du Laboratoire National de Santé Publique
Study Chair: Umberto D'Alessandro, MD Institute of Tropical medicine
  More Information

No publications provided

Responsible Party: Prof. Umberto D'Alessandro, Institute of Tropical Medicine, Antwerp, Belgium
ClinicalTrials.gov Identifier: NCT00730366     History of Changes
Other Study ID Numbers: DELIMAL
Study First Received: August 5, 2008
Last Updated: September 12, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
Malaria
Pregnancy
Intermittent Preventive Treatment

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

ClinicalTrials.gov processed this record on September 18, 2014