New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
Primary Purpose
Malaria in Pregnancy
Status
Completed
Phase
Phase 3
Locations
Burkina Faso
Study Type
Interventional
Intervention
sulfadoxine-pyrimethamine
Chloroquine
Sponsored by
About this trial
This is an interventional prevention trial for Malaria in Pregnancy focused on measuring Malaria, Pregnancy, Intermittent Preventive Treatment
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
Sites / Locations
- District Sanitaire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Experimental: IPTp-SP + promotion: Active Comparator
IPTp-SP alone (without promotion)
Weekly CQ prophylaxis
Outcomes
Primary Outcome Measures
Birth weight
Secondary Outcome Measures
Anemia
Peripheral and placental parasitaemia
Gestational age
Full Information
NCT ID
NCT00730366
First Posted
August 5, 2008
Last Updated
September 12, 2010
Sponsor
Institute of Tropical Medicine, Belgium
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)
1. Study Identification
Unique Protocol Identification Number
NCT00730366
Brief Title
New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
Official Title
New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Tropical Medicine, Belgium
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)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria in Pregnancy
Keywords
Malaria, Pregnancy, Intermittent Preventive Treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2766 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Experimental: IPTp-SP + promotion: Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
IPTp-SP alone (without promotion)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Weekly CQ prophylaxis
Intervention Type
Drug
Intervention Name(s)
sulfadoxine-pyrimethamine
Other Intervention Name(s)
IPTp-SP, SP, Fansidar
Intervention Description
Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
CQ, Nivaquine
Intervention Description
Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week
Primary Outcome Measure Information:
Title
Birth weight
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Anemia
Time Frame
At 32 weeks gestation and at delivery
Title
Peripheral and placental parasitaemia
Time Frame
At 32 weeks gestation (peripheral) and at delivery (both)
Title
Gestational age
Time Frame
At first antenatal visit
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheick Coulibaly Oumar Coulibaly, MD PhD
Organizational Affiliation
Directeur de la Biologie Médicale du Laboratoire National de Santé Publique
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Umberto D'Alessandro, MD
Organizational Affiliation
Institute of Tropical Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
District Sanitaire
City
Boromo
Country
Burkina Faso
12. IPD Sharing Statement
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New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
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