Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

This study has been completed.
Sponsor:
Collaborator:
DBL -Institute for Health Research and Development
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00494416
First received: June 28, 2007
Last updated: May 27, 2010
Last verified: May 2010
  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 visits.
  2. Joint, with an 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. to be able to identify a significant increase in coverage of 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
Other: delivery approaches of malaria intermittent preventive treatment in pregnancy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of Different Approaches for Delivery of Intermittent Preventive Treatment (IPT)to Pregnant Women in Burkina Faso With Regard to Coverage and Compliance

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • compliance [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • coverage [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 11523
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ANC approach
Passive health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.
Other: delivery approaches of malaria intermittent preventive treatment in pregnancy

Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.

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 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).

advanced strategies SP
Joint with advanced strategies delivery approach (JAS). In addition to passive delivery of IPT/sulphadoxine pyrimethamine (SP) 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.
Other: delivery approaches of malaria intermittent preventive treatment in pregnancy

Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.

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 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).

Community based
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.
Other: delivery approaches of malaria intermittent preventive treatment in pregnancy

Health centre based delivery approach (PHC). IPT/SP will be delivered to pregnant women presenting to the health centre for ANC visit.

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 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).


  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Sheick Oumar Coulibaly, Laboratoire Nationale de Santé Publique
ClinicalTrials.gov Identifier: NCT00494416     History of Changes
Other Study ID Numbers: PD 010607, REG-10
Study First Received: June 28, 2007
Last Updated: May 27, 2010
Health Authority: Burkina Faso: Ministry of Health

Additional relevant MeSH terms:
Anemia
Birth Weight
Malaria
Parasitemia
Hematologic Diseases
Body Weight
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 10, 2014