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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/69255
A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
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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.
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TAGBOR, Harry, CAIRNS, Matthew, BOJANG, Kalifa, COULIBALY, Sheikh, KAYENTAO, Kassoum, WILLIAMS, John, ABUBAKAR, Ismaela, AKOR, Francis, MOHAMMED, Khalifa, BATIONO, Richard, DABIRA, Edgar, SOULAMA, Alamissa, DJIMDÉ, Moussa, GUIROU, Etienne, AWINE, Timothy, QUAYE, Stephen l., NJIE, Fanta, ORDI I MAJÀ, Jaume, DOUMBO, Ogobara, HODGSON, Abraham, ODURO, Abraham, MESHNICK, Steven r., TAYLOR, Steve, MAGNUSSEN, Pascal, TER KUILE, Feiko o., WOUKEU, Arouna, MILLIGAN, Paul, CHANDRAMOHAN, Daniel, GREENWOOD, Brian. A Non-Inferiority, Individually Randomized Trial of Intermittent
Screening and Treatment versus Intermittent Preventive Treatment
in the Control of Malaria in Pregnancy. _PLoS One_. 2015. Vol. 10, núm. 8, pàgs. e0132247. [consulta: 14 de gener de 2026]. ISSN: 1932-6203. [Disponible a: https://hdl.handle.net/2445/69255]