This was a double-blind, randomized, three-group
controlled trial comparing sulfadoxine–pyrimethamine,
three-dose dihydroartemisinin–piperaquine,
and monthly dihydroartemisinin–piperaquine as
intermittent preventive treatment for malaria in
pregnancy. Randomization was performed in a
1:1:1 ratio in permuted blocks of 6 or 12. Pharmacists
who were not otherwise involved in the
trial were responsible for treatment assignment
and the preparation of study agents. Six participants
who were randomly assigned to receive
three-dose dihydroartemisinin–piperaquine were
treated with sulfadoxine–pyrimethamine because
of a transcription error.
Each dose of sulfadoxine–pyrimethamine (tablets
of 500 mg of sulfadoxine and 25 mg of pyrimethamine
[Kamsidar, Kampala Pharmaceutical
Industries]) consisted of three tablets taken together;
doses were administered at three times
during the pregnancy (the sulfadoxine–pyrimethamine
group). Each dose of dihydroartemisinin–
piperaquine (tablets of 40 mg of dihydroartemis
neonate for congenital anomalies, measurement
of birth weight, and collection of biologic specimens,
including placental tissue, placental blood,
cord blood, and maternal blood. After delivery,
participants were followed for 6 weeks. Adverse
events were assessed and graded according to
standardized criteria at every visit to the study
clinic.20 Electrocardiography was performed to
assess corrected QT (QTc) intervals with the use
of the Fridericia’s formula in 42 participants just
before their first daily dose of study agents and
3 to 4 hours after their third daily dose of study
agents when they reached 28 weeks of gestation.