Skip to main content

Table 2 Inclusion and exclusion criteria

From: 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

Inclusion criteria

• Ability and willingness to provide informed consenta

• Gestational age of 16 to 26 weeks at enrollment

• Asymptomatic on presentation, with or without a positive RDT test resultb

• Age ≥15 years

• Residence within the study catchment area and no intent to move out of the study catchment area before delivery or to deliver outside of the catchment area

• Willingness to adhere to all study requirements including to deliver at the health facility

• Ability to take oral medication

Exclusion criteria

• Infection with HIV at enrollment or unknown HIV statusc

• History of IPTp-SP or other antimalarial drug use during the current pregnancy

• History of intolerance or allergic reaction to any of the study drugs

• History of known pregnancy complications or bad obstetric history including pre-existing illness likely to cause complication of pregnancy such as repeated abortions, stillbirths or eclampsia

• Hemoglobin concentration <7 g/dL

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

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

• Treatment with antimicrobials with antimalarial activity within the prior 2 weeks (e.g., clindamycin, azithromycin, tetracycline, clarithromycin, levofloxacin)

• Concurrent use of medications with potential for drug-drug interaction or potentiation of cardiac arrhythmiad

• History or presence of major illnesses likely to influence pregnancy outcome including hypertension, diabetes mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis.

  1. HIV, human immunodeficiency virus; IPTp-SP, intermittent preventive treatment with sulfadoxine-pyrimethamine; RDT, rapid diagnostic test for P. falciparum. aFor participants <17 years old, consent will be obtained from the parent or legal guardian and verbal assent will be obtained from the participant. bAsymptomatic defined as absence of fever (temperature <37.5 °C) at baseline and fewer than three of the following symptoms: fever in the past 24 h, headache, weakness/fatigue, myalgia, and arthralgia. cHIV voluntary counseling and testing will be included. We will exclude those on current cotrimoxazole prophylaxis or antiretroviral treatment. dThe list of agents includes pentamidine, antiarrhythmic agents (e.g., amiodarone, sotalol), antihistamines (e.g., promethazine), systemic antifungals (ketoconazole, fluconazole, itraconazole), diuretics (e.g., hydrochlorothiazide, furosemide), antipsychotics (haloperidol, thioridazine), antidepressants (imipramine, citalopram, escitalopram), and antiemetics (domperidone, chlorpromazine, ondansetron)
Back to article page

Trials

ISSN: 1745-6215