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Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial
- Source :
- PLoS Medicine, Vol 13, Iss 9, p e1002124 (2016), PLoS Medicine
- Publication Year :
- 2016
- Publisher :
- Public Library of Science (PLoS), 2016.
-
Abstract
- Background In Africa, most plasmodium infections during pregnancy remain asymptomatic, yet are associated with maternal anemia and low birthweight. WHO recommends intermittent preventive therapy in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP). However, sulfadoxine-pyrimethamine (SP) efficacy is threatened by high-level parasite resistance. We conducted a trial to evaluate the efficacy and safety of scheduled intermittent screening with malaria rapid diagnostic tests (RDTs) and treatment of RDT-positive women with dihydroartemisinin-piperaquine (DP) as an alternative strategy to IPTp-SP. Methods and Findings This was an open-label, two-arm individually randomized superiority trial among HIV-seronegative women at three sites in Malawi with high SP resistance. The intervention consisted of three or four scheduled visits in the second and third trimester, 4 to 6 wk apart. Women in the IPTp-SP arm received SP at each visit. Women in the intermittent screening and treatment in pregnancy with DP (ISTp-DP) arm were screened for malaria at every visit and treated with DP if RDT-positive. The primary outcomes were adverse live birth outcome (composite of small for gestational age, low birthweight [<br />In an open-label randomized controlled trial, Feiko O. ter Kuile and colleagues found that ISTp-DP was not superior to IPTp-SP in an area with high malaria transmission and high SP resistance.<br />Author Summary Why Was This Study Done? Malaria infection during the course of pregnancy can have devastating consequences on the mother and unborn child. Intermittent preventive treatment in pregnancy (IPTp) with the antimalarial sulfadoxine-pyrimethamine (SP) is one of the main interventions to protect pregnant women during pregnancy in malaria endemic areas in sub-Saharan Africa. The effectiveness of SP, however, is threatened by increasing resistance of the malaria parasite to this drug in east and southern Africa. We conducted this study to evaluate if an alternative strategy consisting of screening pregnant women for malaria with rapid diagnostic tests at regular intervals during pregnancy and then treating the test-positive women with dihydroartemisinin-piperaquine (DP) would reduce the risk of malaria infection and the adverse consequences to the mother and newborn. This strategy is called intermittent screening and treatment in pregnancy (ISTp). What Did the Researchers Do and Find? Our team conducted a two-arm, open-label trial to compare the effect of the new ISTp with DP (ISTp-DP) strategy against the existing IPTp with SP (IPTp-SP) strategy (the control arm) in 1,873 pregnant women in southern Malawi, where almost all of the malaria parasites were highly resistant to SP. We found that the rate of malaria infection was high in both groups and that the new ISTp-DP strategy was not any better than the existing IPTp-SP strategy in terms of reducing malaria infection or improving pregnancy outcomes; in fact, women in the ISTp-DP arm had more malaria than women in the IPTp-SP arm. What Do These Findings Mean? ISTp-DP with the current generation of rapid diagnostic tests is not a viable alternative strategy to replace IPTp-SP in malaria endemic areas in sub-Saharan Africa, despite the high levels of resistance to SP. IPTp with SP should still be used as one of the interventions against malaria in pregnancy in sub-Saharan Africa. Further studies to explore alternative drugs that can replace SP for IPTp will be required in these areas of high SP resistance.
- Subjects :
- Malawi
Plasmodium
medicine.medical_treatment
Maternal Health
Biochemistry
law.invention
Labor and Delivery
Families
0302 clinical medicine
Dihydroartemisinin/piperaquine
Randomized controlled trial
law
Pregnancy
Medicine and Health Sciences
030212 general & internal medicine
Children
Protozoans
Obstetrics
Malarial Parasites
Obstetrics and Gynecology
General Medicine
Artemisinins
3. Good health
Drug Combinations
Pyrimethamine
Quinolines
Medicine
Female
Live birth
Infants
medicine.drug
Research Article
Adult
medicine.medical_specialty
wc_20
Adolescent
Sulfadoxine
030231 tropical medicine
qv_38
qv_34
03 medical and health sciences
Antimalarials
Young Adult
Parasite Groups
parasitic diseases
medicine
Parasitic Diseases
Humans
Hemoglobin
Intermittent preventive therapy
business.industry
Diagnostic Tests, Routine
Organisms
Biology and Life Sciences
Proteins
medicine.disease
Tropical Diseases
Sulfadoxine/pyrimethamine
Parasitic Protozoans
Surgery
wc_750
Malaria
Age Groups
Pregnancy Complications, Parasitic
People and Places
Birth
Women's Health
Parasitology
Population Groupings
wq_256
business
Apicomplexa
Subjects
Details
- Language :
- English
- ISSN :
- 15491676 and 15491277
- Volume :
- 13
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- PLoS Medicine
- Accession number :
- edsair.doi.dedup.....64c44b88e031ebf726c3912caaccbec5