Pregnancy Clinical Trial
Official title:
Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial
Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of
maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy
(IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals
in the second and third trimesters of pregnancy irrespective of the presence of malaria
parasitemia, is currently recommended for HIV-negative women in all areas with stable
moderate to high transmission of malaria. Due to increasing resistance to SP, it is no
longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be
decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for
IPTp, as well as to explore the strategy of intermittent screening and treatment in
pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused
antenatal care (FANC) with treatment of women who screen positive.
The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a
reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in
an area with decreasing malaria transmission and high levels of SP resistance in Kenya.
Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of
maternal morbidity and poor birth outcomes. Pregnant women are at increased risk of more
frequent and severe malaria infections than are non-pregnant women. Intermittent preventive
treatment in pregnancy (IPTp), the administration of treatment doses of an antimalarial at
predefined intervals in the second and third trimesters of pregnancy irrespective of the
presence of malaria parasitemia, is currently recommended for HIV-negative women in all
areas with stable moderate to high transmission of malaria. The strategy is thought to work
by providing intermittent clearance or suppression of parasites in the placenta, and
preventing new infections from occurring through the prophylactic effect of the recommended
drug for IPTp, sulfadoxine-pyrimethamine (SP).
SP is the only drug currently used for IPTp. Due to increasing resistance to SP, it is no
longer used as a treatment for symptomatic malaria, however, IPTp with SP remains effective
even in areas where SP resistance in children under five (determined by in vivo efficacy
studies) is up to 26%. SP therefore continues to be used for IPTp in many countries where it
is no longer used for treatment of symptomatic malaria. However, more recent data from
northern Tanzania and Malawi indicate that at higher rates of resistance, IPTp-SP may no
longer be effective, and could potentially be harmful.
In view of this data, a search for alternatives to IPTp-SP is warranted. One strategy would
be to choose a different drug for IPTp. Of the available combinations,
Dihydroartemisinin-Piperaquine (DP) remains one of the most attractive options because of
the long half-life of piperaquine (PQ) and the demonstrated efficacy and safety in
pregnancy. Another strategy to consider is intermittent screening and treatment in pregnancy
(ISTp), whereby there is increased screening at time of focused antenatal care (FANC) with
treatment of women who screen positive. The same properties (long half-life, tolerability,
safety, once daily dosing) which make DP a good choice for IPTp also make it one of the best
available options for ISTp.
This study aims to compare the efficacy of IPTp-SP against that of IPTp-DP and ISTp-DP to
determine if these alternate strategies are associated with a reduction in malaria infection
at delivery among HIV(-) women in an area with decreasing malaria transmission and high
levels of SP resistance in Kenya.
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