Abstract
BackgroundIntermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse outcomes in high burden areas. However, the efficacy of IPTp-SP has decreased in step with increasing parasite drug resistance. Suitable alternative strategies are needed.MethodsThis is a protocol for a phase IIIb open-label, two-armed randomized controlled superiority trial to assess the safety and efficacy of a hybrid approach to IPTp combining screening and treatment with dihydroartemisinin-piperaquine (DP) to the current IPTp-SP regimen at the first antenatal care clinic visit. Pregnant women without HIV infection and without signs or symptoms of malaria will be randomized to either standard IPTp-SP or hybrid IPTp-SP plus screening and treatment (IPTp-SP+). In the IPTp-SP+ arm, participants who screen positive by rapid diagnostic test for P. falciparum will be treated with DP at the first antenatal visit while those who screen negative will receive SP per current guidelines. All participants will be administered SP on days 35 and 63 and will be actively followed biweekly up to day 63 and then monthly until delivery. Infants will be followed until 1 year after delivery. The primary endpoint is incident PCR-confirmed MIP at day 42. Secondary endpoints include incident MIP at other time points, placental malaria, congenital malaria, hemoglobin trends, birth outcomes, and incidence of adverse events in infants up to the first birthday.DiscussionA hybrid approach to IPTp that combines screening and treatment with an artemisinin-based combination therapy at the first visit with standard IPTp-SP is hypothesized to confer added benefit over IPTp-SP alone in a high malaria transmission area with prevalent SP resistant parasites.Trial registrationPan African Clinical Trials Registry 201905721140808. Registered retrospectively on 11 May 2019
Highlights
Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended by the World Health Organization for the prevention of malaria in pregnancy (MIP)-associated adverse outcomes in high burden areas
This clinical trial protocol tests the safety and efficacy of a hybrid approach that combines screening and treatment with rapid diagnostic test (RDT) and dihydroartemisinin-piperaquine (DP) at the first antenatal visit in addition to standard Intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) to reduce the incidence of MIP and improve maternal and birth outcomes in a high-transmission area with moderate to high prevalence of dhps K540E quintuple mutations
Rationale for this study Prevention of malaria during pregnancy is important to maternal and child health in endemic areas, but the spread of drug resistant P. falciparum has compromised the effectiveness of the current standard approach of IPTp-SP [28,29,30,31,32]
Summary
Study design {8} This is a phase IIIb open-label randomized controlled superiority trial of standard IPTp-SP vs. IPTp-SP plus screen-and-treat using DP (IPTp-SP+). Participants randomized to the IPTp-SP arm will receive care according to current national guidelines. Participants who are randomized to the IPTp-SP+ arm will receive standard-ofcare with the addition of screen-and-treat using RDT and DP at the first ANC visit. Study site {9} The trial will take place in Nchelenge District, Luapula Province, Zambia. The district is located in the northern wetlands of Zambia alongside Lake Mweru, an area of hyperendemic malaria [18]. Nchelenge District has one hospital, Saint Paul’s General Hospital (SPGH), twelve rural health centers, and two health posts. The trial will recruit and follow obstetric patients and their offspring at two of the rural health centers and SPGH. SPGH is equipped with an operation theater and labor-and-delivery ward for the provision of essential obstetric services
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