Last Updated: 26/09/2025
Intermittent Screening and Treatment Or intermittent Preventive therapy for the control of Malaria in Pregnancy in Indonesia (STOPMiP-Indonesia)
Objectives
This new project will provide malaria testing to women with or without the symptoms of malaria on every scheduled antenatal visit using a rapid diagnostic test (RDT). The RDT is simple to perform, uses a single drop of blood and gives results within 15 minutes. Those women testing positive will be treated with an artemisinin combination drug called dihydroartemisinin-piperaquine (DHP), which is the treatment of choice in the 2nd and 3rd trimester of pregnancy in Indonesia. A second method called intermittent preventive treatment, which is used in most countries in Africa but not yet in Asia, will also be tested.
With this method, women without symptoms of malaria will be selected to receive the same drug but without prior blood testing. Both methods will be compared with the existing policy in Indonesia, where all pregnant women are tested for malaria on the first antenatal visit only, and those with a positive result are treated with DHP. During subsequent antenatal visits, women are only tested if they have symptoms of malaria such as fever. This means that some infections will go undetected. It is anticipated that the two new methods will either detect infections much earlier than the current approach, or prevent them altogether.
The findings of this study, together with an assessment of feasibility and cost effectiveness of each method, will be used to inform malaria prevention policy for pregnant women in Indonesia and other parts of South East Asia.
Liverpool School of Tropical Medicine (LSTM), United Kingdom
The control of malaria in pregnancy in Indonesia, where approximately 10% of pregnant women get infected with malaria, could receive a potential boost through a new study conducted by the Eijkman Institute for Molecular Biology and the Timika Research Facility in Indonesia. Together with experts from the Liverpool School of Tropical Medicine in the UK, they are going to test two new methods of preventing malaria and the harmful effects in pregnancy. When pregnant women contract malaria this can have devastating consequences for pregnancy, resulting in fever which may trigger preterm onset of labour or even pregnancy loss. It is also possible for women to be infected without showing any outward signs or symptoms, yet if these infections are undetected and left untreated, they can cause anaemia in the mother and can interfere with the growth of the fetus leading to low birth weight, which increases the risk of babies dying during infancy.
Open-label, three-arm, parallel-group multicentre cluster-randomised controlled superiority trial conducted in two rural sites in Eastern Indonesia comparing the efficacy, safety and cost-effectiveness of IPTp and ISTp with the current SSTp strategy. Dihydroartemisinin-piperaquine will be used in all three arms.
Trial ID: ISRCTN34010937
Trial ID: ISRCTN34010937
Study design: Open-label three-arm parallel-group cluster randomised superiority trial
Primary study design: Interventional
Secondary study design: Cluster randomised trial
Trial type: Treatment
Methodology:
The trial was initially designed to detect a 50% reduction in malaria at delivery with IPT or with IST relative to SST across both sites pooled. Following recommendations from the ethics committee in Indonesia on June 27, 2014, to stop recruitment in Sumba because of the unexpected low malaria prevalence in the area, a blinded interim re-estimation of sample size was done with the aim to provide the study with 80% power across both sites pooled and 85% power in Papua alone to detect at least a 50% reduction in the primary outcome (two-sided α value of 0·0167, intracluster correlation coefficient of 0·005; appendix p 9). The revised study required 2279 participants (1290 from Papua and 989 from Sumba), accounting for a 13% efficiency loss owing to varying cluster sizes and 20% loss to follow-up.
Ahmed R., 2019 PMID: 31353217Hoyt J., 2018 PMID: 30261877Hill J., 2018 PMID: 30143041Webster J., 2018 PMID: 30143047
UK Research & Development - Trial detailsISRCTN Trial Details
Oct 2011 — Jun 2017
$4.08M
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