Last Updated

10 Mar 2020

Safety and Efficacy of Intermittent Presumptive Treatment with Sulfadoxine-Pyrimethamine using Rapid Diagnostic Test Screening And Treatment at First Antenatal Care Visit (IPTP-SP+)

Objectives

A clinical trial will be conducted to compare the current IPTp-SP and IPTp-SP added with mRDT and treatment at first ANC visit (IPTp-SP+) in terms of their efficacy at clearing peripheral maternal parasitemia and at preventing adverse outcomes associated with MIP. Volunteer HIV non-infected mothers meeting the inclusion criteria will be recruited. Relevant socio-demographic and clinical information will be obtained and blood samples will be taken for Hemoglobin (Hb) and malaria molecular testing at enrolment; days 14, 28, 42 and 63 and at delivery. In addition cord blood for malaria parasitology will be collected, babies’ Hb will be measured and placental biopsy for malaria parasitology and histopathology will be collected. Data from this study will help MIP leaders to review current practices for the prevention of malaria in pregnancy. This will improve on the number of medical interventions for this special population and in long term reduce the social and economic burden of Poverty Related Diseases (PRDs).

Principal Investigator
Rationale and Abstract

Malaria in pregnancy (MIP) may result in serious clinical consequences for the mother and her offspring. In moderate to high transmission areas of sub-Saharan Africa, World Health Organization (WHO) recommends the use of long-lasting insecticidal nets (LLINs) coupled with Intermittent Preventive Treatment in Pregnancy (IPTp) with Sulafadoxine-Pyrimethamine (SP) and/or treatment of confirmed cases to prevent the occurrences of those complications; concerns on IPTp with SP (IPTp-SP) efficacy have been raised as evidence has shown that IPTp-SP efficacy has been decreasing in relation with the ever increasing parasite resistance to SP. However, SP remains the recommended antimalarial drug for IPTp as the currently evaluated alternative drugs and strategies have shown to be not suitable to replace SP for IPTp or IPTp-SP itself. The continued use of SP for IPTp would result to further reduction of IPTp-SP efficacy and completely compromise its effectiveness at preventing MIP associated adverse outcomes. This constitutes a serious threat for mothers and their offspring in sub-Saharan Africa. Reducing SP interaction with the already mutated parasite would prevent further selection of mutated parasites, reduce SP resistance and improve its efficacy. This can be achieved by introducing at first Antenatal (ANC) visit, malaria Rapid Diagnostic Testing (mRDT) and treatment of positive mothers with a fully effective antimalarial drug before they are administered with SP while negative mothers receive SP as per current standard practices.

Date

2018 Jul - 2021 Jun

Total Project Funding

$175,208
Project Site
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