Intermittent Preventive Treatment (IPTp) Versus Rapid Diagnostic Testing (RDT) and Treatment of Malaria in Pregnancy
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Among the best practices recommended for malaria control during pregnancy is ensuring
effective case management of malaria illness. However, this is often not practiced because
(1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be
absent even when the placenta is heavily parasitized, (3) implementing diagnosis and
treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial
treatment options available to pregnant women are limited due to resistance to
chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on
other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT).
Therefore the commonest recommended practice in pregnancy is the administration of SP as
intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been
questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa.
This is a three-arm open label randomised control non-inferiority trial of
insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with
SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried
out in pregnant women of all parities presenting at enrolling antenatal clinics with a
gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate
that (1) the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation (2) the
prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery (3)
the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious
adverse events in the ITN plus RDT screening and treatment arm are not greater than those in
the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will
be done to determine the cost-effectiveness of the two delivery strategies measured as cases
of severe maternal anaemia averted.
Phase:
Phase 3
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborator:
Kwame Nkrumah University of Science and Technology
Treatments:
Amodiaquine Artesunate Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine