Pregnant women of all gravidities attending an ANC clinic for the first time and who had not received IPTp during their current pregnancy were invited to participate in the study after provision of informed consent. Inclusion criteria were: permanent residence in the study area, gestational age ≤28 weeks, negative HIV-testing at recruitment, absence of history of allergy to sulfa drugs or MQ, absence of history of severe renal, hepatic, psychiatric, or neurological disease, and of MQ or halofantrine treatment in the preceding 4 weeks. Gestational age was determined from fundal height measurement by bimanual palpation. Women not meeting inclusion criteria received standard ANC following national guidelines. Hemoglobin (Hb), HIV test and the syphilis rapid plasma reagin test (RPR) were assessed at the first antenatal visit as per local standard procedures. In Mozambique and Tanzania, HIV-infected women were invited to participate in a placebo-controlled trial evaluating MQ IPTp in women on daily cotrimoxazole prophylaxis [26] (link). The allocation of the participants to the study arms was done centrally by randomization stratified by country according to a 1∶1∶1 scheme. The sponsor's institution biostatistician produced the computer-generated randomization list for each recruiting site. Treatment allocation for each participant was concealed in opaque sealed envelopes that were opened only after recruitment. Study participants were assigned a unique study number linked to the allocated treatment group. All participants received a LLITN (PermaNet, Vestergaard Fransen) at enrolment as part of the study intervention.
Following physical examination, recruited women with gestational age ≥13 weeks received their first dose of IPTp (either SP or MQ) under supervision. Women allocated to the SP group received standard IPTp (three tablets of the fixed combination therapy containing 500 mg of sulfadoxine and 25 mg of pyrimethamine, Malastop, Sterop), whereas participants allocated to the MQ groups received 15 mg/kg of the drug (Lariam, Roche, tablets of 250 mg of MQ base). The number of tablets was calculated according to body weight, thus a woman weighing 70 kg would receive four and a quarter tablets. The maximum dosage would not exceed 1,500 mg of MQ base corresponding to six tablets. For women allocated to the MQ split dose group, the 15 mg/kg dose was divided into two halves and administered over two consecutive days with the second half dose administered either at the ANC clinic or at home (by study personnel). All study participants were observed for 60 minutes following IPT administration. Women who vomited within the first 30 minutes were provided a second full IPT dose and those vomiting 30–60 minutes after drug intake were given a half replacement dose. Home visits by field workers were done two days after IPTp administration to assess drug tolerability and correct LLITN use. The second IPTp-SP/MQ administration was given at least one month later than the first one.
Following physical examination, recruited women with gestational age ≥13 weeks received their first dose of IPTp (either SP or MQ) under supervision. Women allocated to the SP group received standard IPTp (three tablets of the fixed combination therapy containing 500 mg of sulfadoxine and 25 mg of pyrimethamine, Malastop, Sterop), whereas participants allocated to the MQ groups received 15 mg/kg of the drug (Lariam, Roche, tablets of 250 mg of MQ base). The number of tablets was calculated according to body weight, thus a woman weighing 70 kg would receive four and a quarter tablets. The maximum dosage would not exceed 1,500 mg of MQ base corresponding to six tablets. For women allocated to the MQ split dose group, the 15 mg/kg dose was divided into two halves and administered over two consecutive days with the second half dose administered either at the ANC clinic or at home (by study personnel). All study participants were observed for 60 minutes following IPT administration. Women who vomited within the first 30 minutes were provided a second full IPT dose and those vomiting 30–60 minutes after drug intake were given a half replacement dose. Home visits by field workers were done two days after IPTp administration to assess drug tolerability and correct LLITN use. The second IPTp-SP/MQ administration was given at least one month later than the first one.
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