Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial

Table 3 Schedule of events

	Antenatal period Study day									Postpartum period Study month
Event	0	1–2	14	28	35	42	63^a	Unsch.	Birth	1	6	9	12
Informed consent/oral assent	•
Medical history	•
Physical examination, including height, weight, temperature	•		•	•	•	•	•	•	•
Fetal viability	•		•	•	•	•	•	•	•
Focused history and examination			•	•	•	•	•	•	•	•	•	•	•
Adverse event evaluation	•	•	•	•	•	•	•	•
IPTp-SP^b	•				•		•
RDT^c	•
Treatment with DP^d	•	•
DBS for PCR, genotyping	•		•	•	•	•	•	•	•
Malaria microscopy^e			•	•	•	•	•	•	•
Hemoglobin measurement	•		•	•		•	•		•	•
Blood sample for PK^d	•		•	•	•	•
Delivery									•
Placental biopsy, cord blood									•
Infant assessment including history and exam, weight, heel stick									•	•	•	•	•

^aMonthly visits continue until delivery
^bIncludes participants randomized to standard IPTp-SP, participants randomized to IPTp-SP+ who test negative at the first visit, and all participants in both groups at days 35, 63 and then monthly until delivery
^cLimited to participants randomized to IPTp-SP+
^dLimited to participants randomized to IPTp-SP+ who test positive by RDT at the first visit
^eOnly participants with signs or symptoms of malaria will undergo microscopy
DBS dried blood spot, DP dihydroartemisinin-piperaquine, IPTp-SP intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine, PCR polymerase chain reaction, PK pharmacokinetics, RDT rapid diagnostic test for P. falciparum infection

ISSN: 1745-6215