Clinical Trials Logo

Clinical Trial Summary

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For the latter, 3 or more doses are recommended by the national malaria control program (NMCP) but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by perceptions, acceptability and contextual factors that need to be understood and therefore improve the effectiveness of this health interventions. In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many malaria cases are missed in pregnant women due to the power performance of recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT could improve the outcome of the pregnancy in addition to IPTp-SP.


Clinical Trial Description

MiP remains a major public health issue in Burkina Faso, which would compromise the achievement of Sustainable Development Goals for maternal and child health (22). Malaria control program have been implemented by the Burkinabe Ministry of Health (MoH) since 2000; nevertheless, lower coverage and delays in implementation of these programs may have reduced their effectiveness. In Burkina Faso, recommended preventions strategies for malaria imply the administration of at least 3 doses of IPTp during ANCs and before delivery (23). IPTp have been proven to have a great impact on PM, LBW and peripheral malaria infection at delivery so increasing the number of IPTp doses given is a priority. Strategies to increase the number of IPTp doses and the coverage using reminders could improve this health intervention effectiveness. This can be considered as follow up of the Cosmic study (24) recommendations. However with increasing drug resistance, there is a progressively diminished efficacy of IPTp-SP in clearing existing infections and a shortening of the post-treatment prophylaxis period (25). Moreover, pregnant women can generally be infected with low parasites densities between ANCs compromising the outcome of the pregnancy (26). Therefore, additional screening with HS-RDTs between ANCs and treatment using ACTs with long Post-treatment prophylaxis effect in addition to IPTp-SP could have a great impact both for the mothers and their offspring's. This proposal aims to determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on placental malaria (PM) and low birth weight (LBW) in a context of IPTp-SP, in rural central Burkina Faso. The findings obtained from this study will help to assist the MoH in the implementation of the appropriate interventions in this group at risk. Objectives General objective - To determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in in Burkina Faso Specific objectives are the following: - To determine the gain of additional screening with HS-RDTs and treatment with DP against PM, LBW and peripheral malaria infection at delivery - To assess the determinants of the poor coverage and improve the number of IPTp doses received using phone call or SMS as a reminder ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04147546
Study type Interventional
Source Institut de Recherche en Sciences de la Sante, Burkina Faso
Contact
Status Completed
Phase Phase 3
Start date August 31, 2020
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT04577066 - Safety and Preliminary Protective Efficacy of Genetically Attenuated GA2 Parasites. Phase 1/Phase 2
Completed NCT01883609 - A Safety and Efficacy Study of ChAd63/MVA METRAP + RTS,S Phase 1/Phase 2
Completed NCT00593398 - Malarial Immunity in Pregnant Cameroonian Women
Completed NCT01659281 - Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand N/A
Completed NCT00074841 - Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India Phase 2/Phase 3
Recruiting NCT04416945 - Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic N/A
Completed NCT00314899 - Fetal Immunity to Falciparum Malaria
Completed NCT02867059 - SJ733 Induced Blood Stage Malaria Challenge Study Phase 1
Completed NCT00701961 - Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy Phase 2/Phase 3
Completed NCT00707200 - The Cytoadherence in Pediatric Malaria (CPM) Study N/A
Completed NCT00338520 - Hyperphenylalaninemia in Cerebral Malaria N/A
Completed NCT00393757 - Malaria Transmission and Immunity in Highland Kenya
Completed NCT03783299 - Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic Phase 4
Completed NCT02614404 - Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria Phase 1
Completed NCT00358332 - Phase I Pediatric FMP2.1/AS02A Trial in Mali Phase 1
Completed NCT00730782 - Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers Phase 1
Completed NCT00349713 - FMP2.1 Trial in Bandiagara, Mali Phase 1
Recruiting NCT05052502 - Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand N/A
Completed NCT04093765 - Mass Screening and Treatment for Reduction of Falciparum Malaria N/A
Completed NCT03764527 - Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar Phase 4