Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

NCT00494416 | Completed

• 2 other identifiers: PD 010607REG-10
• Study Type: interventional
• Target: 11,523
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Malaria Parasitaemia; Birth Weight; Anaemia

Outcome Measures

Primary Outcomes (2)

• compliance

  24 month after study start

• coverage

  24 month after study start

Study Arms (3)

ANC approach

NO INTERVENTION

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

advanced strategies SP

OTHER

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

Community based

OTHER

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

Interventions

delivery approaches of malaria intermittent preventive treatment in pregnancy OTHER

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; advanced strategies SP

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women of all parities
• Second trimester

You may not qualify if:

• Severely ill pregnant women
• Pregnant women in first trimester

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• DBL -Institute for Health Research and Development: collaborator

Study Sites (1)

Pissy Health District

Ouagadougou, Ouagadougou, 09, Burkina Faso

Location

Related Links

• DBL-Centre for Health Research and Development

MeSH Terms

Conditions

Birth Weight; Anemia

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Sheick O Coulibaly, MD, PhD

  Laboratoire National de Sante Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

BU (1)