Intermittent Screening and Treatment versus Intermittent Preventive Treatment of Malaria in Pregnancy: A Randomised Controlled Non-Inferiority Trial
Open accessAbstract
BACKGROUND: The effectiveness of intermittent preventive treatment of malaria in pregnancy (IPTp) may be compromised by the spread of resistance to sulphadoxine/pyrimethamine (SP) across Africa. But little information exists on alternative drugs for IPTp or alternative strategies for the prevention of malaria in pregnancy. Therefore, we have investigated whether screening with a rapid diagnostic test and treatment of those who are positive (IST) at routine antenatal clinic attendances is as effective and as safe as SP-IPTp in pregnant women. METHODS AND FINDINGS: During antenatal clinic sessions in six health facilities in Ghana held between March 2007 and September 2007, 3333 pregnant women who satisfied inclusion criteria were randomised into three intervention arms (1) standard SP-IPTp, (2) IST and treatment with SP or (3) IST and treatment with amodiaquine+artesunate (AQ+AS). All women received a long-lasting insecticide treated net. Study women had a maximum of three scheduled follow-up visits following enrollment. Haemoglobin concentration and peripheral parasitaemia were assessed between 36 and 40 weeks of gestation. Birth weight was measured at delivery or within 72 hours for babies delivered at home. Parasite prevalence at enrollment in primigravidae and in multigravidae was 29.6% and 10.2% respectively. At 36-40 weeks of gestation the prevalence of asymptomatic parasitaemia was 12.1% in study women overall and was very similar in all treatment groups. The risk of third trimester severe anaemia or low birth weight did not differ significantly between the three treatment groups regardless of gravidity. IST with AQ+AS or SP was not inferior to SP-IPTp in reducing the risk of low birth weight (RD = -1.17[95%CI; -4.39-1.02] for IST-SP vs. SP-IPTp and RD = 0.78[95%CI; -2.11-3.68] for IST-AQAS vs. SP-IPTp); third trimester severe anaemia (RD = 0.29[95%CI; -0.69-1.30] for IST-SP vs. SP-IPTp and RD = -0.36[95%CI;-1.12-0.44] for IST-AQAS vs. SP-IPTp). CONCLUSION: The results of this study suggest that in an area of moderately high malaria transmission, IST with SP or AS+AQ may be a safe and effective strategy for the control of malaria in pregnancy. However, it is important that these encouraging findings are confirmed in other geographical areas and that the impact of IST on placental malaria is investigated. TRIAL REGISTRATION: ClinicalTrials.gov NCT00432367 [NCT00432367].
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In stable transmission settings, most malaria infections in pregnancy are asymptomatic but increase substantially the risk of anaemia.
“Where transmission is stable, such as in most of sub-Saharan Africa, most infections are asymptomatic but increase substantially the risk of anaemia.19,26,30–31”
From Malaria in pregnancy. (2013) · cites this paper as [26]
The Results (Baseline demographic and clinical characteristics; page unavailable) report asymptomatic parasitaemia in 16.3% of study women and a significant association between asymptomatic parasitaemia and anaemia at enrolment. They do not establish that most infections were asymptomatic. In the Results (Study outcomes – per protocol analysis; page unavailable), baseline parasitaemia was only marginally associated with third-trimester severe anaemia after adjustment (p=0.07), so the claim of a substantial increase in risk is stronger than this trial establishes. (LLM, conf=0.85)
Experimental — accuracy not yet measuredSystematic screening for malaria infections at regular intervals and treatment of positive women has been shown to have similar protective efficacy than IPTp.
“It has already be shown to have similar protective efficacy than IPTp but additional trials for a more thorough evaluation of this intervention are probably needed.26”
From Malaria in pregnancy. (2013) · cites this paper as [26]
ISTp using an LDH-based RDT prevents LBW and severe anaemia to a similar extent to SP-IPTp in an area of moderately high transmission in Ghana.
“Results of the first reported trial of ISTp, which was conducted in an area of moderately high malaria transmission in Ghana, suggest that ISTp using an lactate dehydrogenase-based RDT prevents LBW and severe anaemia to a similar extent to SP-IPTp [10]”
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References 27 · Cited by 113
Research works printed but not linked: 1
- [15]Mbaye A Richardson K Balajo B Dunyo S Shulman C 2006 A randomized, placebo-controlled trial of intermittent preventive treatment with sulphadoxine-pyrimethamine in Gambian multigravidae. Trop Med Int Health 11 992 1002 16827700
- Authors
- Tagbor, H., Bruce, J., Agbo, M., Greenwood, B., & Chandramohan, D.
- Affiliations
- Kwame Nkrumah University of Science and Technology (GH)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Tagbor, Harry
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2010-12-28
- Volume
- 5
- Issue
- 12
- Pages
- e14425
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3010999
- OpenAlex
- W2006928697
- Cited by
- 113
- References
- 27
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2022: 10 · 2021: 6 · 2020: 6 · 2019: 2 · 2018: 7 · 2017: 6 · 2016: 7 · 2015: 15 · 2014: 14 · 2013: 7 · 2012: 21
- FWCI
- 11.45
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- Bill and Melinda Gates Foundation
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Health Sciences › Medicine › Genetics › Hemoglobinopathies and Related Disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
- Keywords
- malaria in pregnancy, intermittent preventive treatment, intermittent screening and treatment, rapid diagnostic tests, sulfadoxine-pyrimethamine, low birth weight, antimalarial drug resistance, primigravida, multigravidae, prenatal care, long-lasting insecticidal nets
- MeSH terms
- Adolescent, Adult, Antimalarials, Drug Combinations, Drug Resistance, Female, Geography, Ghana, Humans, Malaria, Pregnancy, Prenatal Care, Pyrimethamine, Sulfadoxine, Models, Statistical, Pregnancy Complications, Parasitic, Treatment Outcome
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