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Table 2 Inclusion and exclusion criteria

From: Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria: a multicentre randomized control trial

Inclusion criteria

Patients eligible for inclusion in the trial must fulfil all of the following criteria

 

Gestation ≥16 weeks and <37 weeks;

P. falciparum monoinfection of any density, with or without symptoms

Hb ≥ 7 g/dL;

At least 15 years old;

Residence within the health facility catchment’s area;

Willing to deliver at the health facility;

Willing to adhere to the study requirements (including, in Zambia and Malawi, HIV VCT)

 

Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, the investigator is responsible to check that the woman herself is also freely willing to take part in the study).

Exclusion criteria

Patients who meet any of the following criteria are not eligible for the study

 

History of allergic reactions to the study drugs;

History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;

History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;

Current cotrimoxazole prophylaxis or ARV treatment;

Any significant illness at the time of screening that requires hospitalization, including severe malaria;

Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area.

Prior enrollment in the study or concurrent enrollment in another study.

Unable to take oral medication

 

Clear evidence of recent (1 week) treatment with antimalarials or antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)