The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract
Status:
Recruiting
Trial end date:
2022-11-07
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy has devastating consequences for mother and foetus. WHO recommends
intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP)
for asymptomatic women, but high-level parasite resistance to SP threatens its efficacy.
Dihydroartemisinin-piperaquine (DP) has the potential to replace SP for IPTp. However, the DP
strategy has not been found to be superior to SP for reducing the incidence of low
birthweight (LBW), small-for-gestational age (SGA), or preterm birth. This may be the result
of sulphadoxine having antibacterial properties; it is derived from sulphonamide, which have
been used for decades to treat curable STIs/RTIs. However, SP is unlikely to be curative of
STIs/RTIs, nor highly effective against malaria parasites. Thus, combination treatment that
contains a more efficacious antimalarial and a more efficacious anti-STI/RTI may produce
better birth outcomes. The investigators will therefore determine whether combining SP with
metronidazole (MTZ) or, separately, DP with MTZ can improve birth outcomes more than SP
alone, potentially paving the way for integrated control strategies that will reduce the dual
burden of malaria and curable STIs/RTIs.
This is an individually-randomized, 3-arm, partially-placebo controlled superiority trial
comparing the efficacy, safety and tolerance of IPTp-SP versus IPTp-SP with MTZ, or IPTp-DP
with MTZ to reduce adverse birth outcomes attributable to malaria and curable STIs/RTIs in
5,436 women in the Nchelenge District of Zambia.