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Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

This study is not yet open for participant recruitment.
Verified by Gates Malaria Partnership, June 2007

Sponsors and Collaborators: Gates Malaria Partnership
DBL -Institute for Health Research and Development
Information provided by: Gates Malaria Partnership
ClinicalTrials.gov Identifier: NCT00494416
  Purpose

IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ in pregnancy. The new strategy is being implemented but no delivery approach was defined and presumably IPT/SP will only be delivered to pregnant women presenting at ANC visits. It would be of extreme importance to ensure a better coverage and higher compliance to make the new strategy effective. In order to obtain a more efficient IPT/SP programme with a good level of compliance and coverage, several delivery approaches beside ANC should be explored.

The study site will be in Pissy health district covering both peri-urban Ouagadougou city and rural areas. Participants include pregnant women irrespective of gravidity residing in the study area.

The study is a prospective comparative study of 3 different approaches of delivering IPT/SP in the catchment areas of rural health facilities. The approaches will be the following:

  1. Passive health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.
  2. Joint with advanced strategies delivery approach (JAS). In addition to passive delivery at health centres, the pregnant women will be reached during preventive activities the health staff carry out regularly in villages, such as immunization, health promotion, and even ANC visits.
  3. Community based distribution delivery approach (CBD). In addition to passive delivery at health centres, the pregnant women will be reached by traditional birth attendants (TBAs) or representatives of village women’s associations (RWAs). Each approach will be implemented in a zone constituted by the catchment area of a number of health centres to achieve the required sample size. The zones will be randomly assigned to a delivery approach. The main outcomes to be measured are: a) the coverage of IPT, b) compliance, c) infection prevalence, d) Hb level, e) difficulties and constraints of each approach, f) the acceptability to population and health staff and g) the performance of each approach to deliver IPT /SP. Coverage by 10%, each group should be composed of n = 3841 pregnant women.

Cross sectional surveys will be carried out at the beginning, during and at the end of the study period. The study will be carried out over 24 months from June 2007.


Condition Intervention
Malaria Parasitaemia
Birth Weight
Anaemia
Drug: sulphadoxine-pyrimethamine intermittent preventive treatment

MedlinePlus related topics:   Malaria   

Drug Information available for:   Pyrimethamine    Sulfadoxine    Fansidar   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Factorial Assignment
Official Title:   A Comparison of Different Approaches for Delivery of Intermittent Preventive Treatment (IPT)to Pregnant Women in Burkina Faso With Regrad to Coverage and Compliance

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • compliance
  • coverage

Estimated Enrollment:   11523
Study Start Date:   June 2007
Estimated Study Completion Date:   November 2007

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Pregnant women of all parities
  • Second trimester

Exclusion Criteria:

  • Severely ill pregnant women
  • Pregnant women in first trimester
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494416

Locations
Burkina Faso
Pissy Health District    
      Ouagadougou, Burkina Faso, 09

Sponsors and Collaborators
Gates Malaria Partnership
DBL -Institute for Health Research and Development

Investigators
Principal Investigator:     Sheick O Coulibaly, MD, PhD     Laboratoire National de Sante Publique    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   PD 010607, REG-10
First Received:   June 28, 2007
Last Updated:   June 28, 2007
ClinicalTrials.gov Identifier:   NCT00494416
Health Authority:   Burkina Faso: Ministry of Health

Study placed in the following topic categories:
Birth Weight
Systemic Inflammatory Response Syndrome
Pyrimethamine
Sulfadoxine-pyrimethamine
Anemia
Malaria
Sulfadoxine
Inflammation
Folic Acid
Body Weight
Signs and Symptoms
Sepsis
Parasitemia
Parasitic Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008




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