# name
A Non-Inferiority, Individually Randomized Trial of Intermittent
                Screening and Treatment versus Intermittent Preventive Treatment
                in the Control of Malaria in Pregnancy

# metadata.dc.description.abstract[].value
BACKGROUND: The efficacy of intermittent preventive treatment
                for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in
                pregnancy is threatened in parts of Africa by the emergence and
                spread of resistance to SP. Intermittent screening with a rapid
                diagnostic test (RDT) and treatment of positive women (ISTp) is
                an alternative approach. METHODS AND FINDINGS: An open,
                individually randomized, non-inferiority trial of IPTp-SP versus
                ISTp was conducted in 5,354 primi- or secundigravidae in four
                West African countries with a low prevalence of resistance to SP
                (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP
                group received SP on two or three occasions whilst women in the
                ISTp group were screened two or three times with a RDT and
                treated if positive for malaria with artemether-lumefantrine
                (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low
                birth weight (LBW), anemia and placental malaria, the primary
                trial endpoints. The prevalence of LBW was 15.1% and 15.6% in
                the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI:
                0.88, 1.22]). The mean hemoglobin concentration at the last
                clinic attendance before delivery was 10.97g/dL and 10.94g/dL in
                the IPTp-SP and ISTp-AL groups respectively (mean difference:
                -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of
                the placenta was found in 24.5% and in 24.2% of women in the
                IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81,
                1.12]). More women in the ISTp-AL than in the IPTp-SP group
                presented with malaria parasitemia between routine antenatal
                clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000
                pregnancies [95% CI 30.5, 68.3], but the number of hospital
                admissions for malaria was similar in the two groups.
                CONCLUSIONS: Despite low levels of resistance to SP in the study
                areas, ISTp-AL performed as well as IPTp-SP. In the absence of
                an effective alternative medication to SP for IPTp, ISTp-AL is a
                potential alternative to IPTp in areas where SP resistance is
                high. It may also have a role in areas where malaria
                transmission is low and for the prevention of malaria in HIV
                positive women receiving cotrimoxazole prophylaxis in whom SP is
                contraindicated. TRIAL REGISTRATION: ClinicalTrials.gov
                NCT01084213 Pan African Clinical trials Registry
                PACT201202000272122.

# metadata.dc.relation.isformatof[].value
Reproducció del document publicat a:
                http://dx.doi.org/10.1371/journal.pone.0132247

# metadata.dc.source[].value
Articles publicats en revistes (Fonaments Clínics)

# metadata.dc.title[].value
A Non-Inferiority, Individually Randomized Trial of Intermittent
                Screening and Treatment versus Intermittent Preventive Treatment
                in the Control of Malaria in Pregnancy