Clinical Trial: Different Approaches for Delivery of IPT in Pregnancy in Burkina Faso

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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. 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

    Detailed Summary:

    Pregnant women are more susceptible to malaria than non-pregnant women, in particular during the first pregnancies. Malaria infection in pregnant women may cause anaemia, illness and abortion or stillbirth. It may also cause low birth weight through placental infection. In Africa the burden of malaria in pregnancy is highest in remote rural areas. IPT with sulphadoxine - pyrimethamine (SP) has been demonstrated to be effective in preventing pregnancy related malaria (anaemia, clinical cases and placenta infection), and to be beneficial to both babies and pregnant women, and increasing ANC attendance. In many Sub - Saharan African countries, IPT / SP is being adopted to replace chloroquine (CQ) as chemoprophylaxis was shown to be no longer efficacious. IPT/SP was adopted in 2005 by The Ministry of Health (MoH) of Burkina Faso to replace chemoprophylaxis with CQ. 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. Although the expected compliance should be better than for the previous CQ weekly regime, it would be of importance to ensure a better coverage and higher compliance to make the new strategy effective. Therefore, in order to obtain a more efficient IPT / SP programme with a good level of compliance and coverage, several delivery approaches beside use of ANC alone will be explored. It is hypothesized that the IPT strategy using SP will be as inefficient as chemoprophylaxis with CQ if an effective delivery approach is not used.

    General Objective: to assess different IPT/SP delivery approaches in rural Burkina Faso with the aim of improving coverage and compliance among pregnant women.

    Specific objectives:

    • To implement three ap
      Sponsor: London School of Hygiene and Tropical Medicine

      Current Primary Outcome:

      • compliance [ Time Frame: 24 month after study start ]
      • coverage [ Time Frame: 24 month after study start ]


      Original Primary Outcome:

      • compliance
      • coverage


      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: London School of Hygiene and Tropical Medicine

      Dates:
      Date Received: June 28, 2007
      Date Started: June 2007
      Date Completion:
      Last Updated: January 25, 2017
      Last Verified: January 2017