Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol
Introduction Malaria is one of the major public health problems in sub-Saharan Africa. It contributes significantly to maternal and fetal morbidity and mortality in affected countries. This study aims to evaluate the impact of enhanced case detection using molecular testing called loop-mediated isot...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e058397.full |
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| author | Mekonnen Teferi Claire Kamaliddin Hiwot Tilahun Rediet Fikru Gebresenbet Zelalem Mekonnen Bekele Banchamlak Tegegne Delenasaw Yewhalaw Abebe Genetu Bayih Dylan R Pillai Filmona Mekuria Getaneh Alemu Beka Raya Omar Abdullah Taye Teka James Cheaveau Ruth Legese Hiwot Asmerom Ermias Hundito Ebrahim Nursefa Samuel Ayele |
| author_facet | Mekonnen Teferi Claire Kamaliddin Hiwot Tilahun Rediet Fikru Gebresenbet Zelalem Mekonnen Bekele Banchamlak Tegegne Delenasaw Yewhalaw Abebe Genetu Bayih Dylan R Pillai Filmona Mekuria Getaneh Alemu Beka Raya Omar Abdullah Taye Teka James Cheaveau Ruth Legese Hiwot Asmerom Ermias Hundito Ebrahim Nursefa Samuel Ayele |
| author_sort | Mekonnen Teferi |
| collection | DOAJ |
| description | Introduction Malaria is one of the major public health problems in sub-Saharan Africa. It contributes significantly to maternal and fetal morbidity and mortality in affected countries. This study aims to evaluate the impact of enhanced case detection using molecular testing called loop-mediated isothermal amplification (LAMP) on birth outcomes in a prospective study design.Methods and analysis A pragmatic randomised diagnostic outcomes trial will be conducted in several health institutes in different Ethiopian regions. Women (n=2583) in their first and second trimesters of pregnancy will be included in the study and individually randomised to the standard of care or enhanced case detection arms, and followed until delivery. Enrolment will encompass the malaria peak transmission seasons. In the standard of care arm, a venous blood sample will be collected for malaria diagnosis only in symptomatic patients. In contrast, in the intervention arm, mothers will be tested by a commercially available Conformité Européene (CE)-approved LAMP malaria test, microscopy and rapid diagnostic test for malaria regardless of their symptoms at each antenatal care visit. The primary outcome of the study is to measure birth weight.Ethics and dissemination The study was approved by the following ethical research boards: Armauer Hansen Research Institute/ALERT Ethics Review Committee (FORM AF-10-015.1, Protocol number PO/05/20), the Ethiopia Ministry of Science and Higher Education National Research Ethics Review Committee (approval SRA/11.7/7115/20), the Ethiopia Food and Drug Administration (approval 02/25/33/I), UCalgary Conjoint Health Research Ethics Board (REB21-0234). The study results will be shared with the institutions and stakeholders such as the Ethiopia Ministry of Health, the Foundation for Innovative Diagnostics, WHO’s Multilateral initiative on Malaria - Tropical Diseases Research (TDR-MIM), Roll Back Malaria and the Malaria in Pregnancy Consortium. The study results will also be published in peer-reviewed journals and presented at international conferences.Trial registration number NCT03754322. |
| format | Article |
| id | doaj-art-02448f0fffa248ca8816b145beea162b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-02448f0fffa248ca8816b145beea162b2025-01-31T17:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-058397Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocolMekonnen Teferi0Claire Kamaliddin1Hiwot TilahunRediet Fikru Gebresenbet2Zelalem Mekonnen Bekele3Banchamlak Tegegne4Delenasaw Yewhalaw5Abebe Genetu Bayih6Dylan R Pillai7Filmona MekuriaGetaneh AlemuBeka RayaOmar AbdullahTaye TekaJames CheaveauRuth LegeseHiwot AsmeromErmias HunditoEbrahim NursefaSamuel AyeleClinical Trials Unit, Armauer Hansen Research Institute, Addis Ababa, Oromia, EthiopiaPathology and Laboratory Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, CanadaArmauer Hansen Research Institute, Addis Ababa, EthiopiaArmauer Hansen Research Institute, Addis Ababa, EthiopiaAmhara Public Health Institute, Bahir Dar, EthiopiaTropical and Infectious Disease Research Center, Jimma University, Jimma, EthiopiaArmauer Hansen Research Institute, Addis Ababa, EthiopiaMicrobiology, Immunology and Infectious Diseases, University of Calgary Cumming School of Medicine, Calgary, Alberta, CanadaIntroduction Malaria is one of the major public health problems in sub-Saharan Africa. It contributes significantly to maternal and fetal morbidity and mortality in affected countries. This study aims to evaluate the impact of enhanced case detection using molecular testing called loop-mediated isothermal amplification (LAMP) on birth outcomes in a prospective study design.Methods and analysis A pragmatic randomised diagnostic outcomes trial will be conducted in several health institutes in different Ethiopian regions. Women (n=2583) in their first and second trimesters of pregnancy will be included in the study and individually randomised to the standard of care or enhanced case detection arms, and followed until delivery. Enrolment will encompass the malaria peak transmission seasons. In the standard of care arm, a venous blood sample will be collected for malaria diagnosis only in symptomatic patients. In contrast, in the intervention arm, mothers will be tested by a commercially available Conformité Européene (CE)-approved LAMP malaria test, microscopy and rapid diagnostic test for malaria regardless of their symptoms at each antenatal care visit. The primary outcome of the study is to measure birth weight.Ethics and dissemination The study was approved by the following ethical research boards: Armauer Hansen Research Institute/ALERT Ethics Review Committee (FORM AF-10-015.1, Protocol number PO/05/20), the Ethiopia Ministry of Science and Higher Education National Research Ethics Review Committee (approval SRA/11.7/7115/20), the Ethiopia Food and Drug Administration (approval 02/25/33/I), UCalgary Conjoint Health Research Ethics Board (REB21-0234). The study results will be shared with the institutions and stakeholders such as the Ethiopia Ministry of Health, the Foundation for Innovative Diagnostics, WHO’s Multilateral initiative on Malaria - Tropical Diseases Research (TDR-MIM), Roll Back Malaria and the Malaria in Pregnancy Consortium. The study results will also be published in peer-reviewed journals and presented at international conferences.Trial registration number NCT03754322.https://bmjopen.bmj.com/content/12/7/e058397.full |
| spellingShingle | Mekonnen Teferi Claire Kamaliddin Hiwot Tilahun Rediet Fikru Gebresenbet Zelalem Mekonnen Bekele Banchamlak Tegegne Delenasaw Yewhalaw Abebe Genetu Bayih Dylan R Pillai Filmona Mekuria Getaneh Alemu Beka Raya Omar Abdullah Taye Teka James Cheaveau Ruth Legese Hiwot Asmerom Ermias Hundito Ebrahim Nursefa Samuel Ayele Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol BMJ Open |
| title | Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol |
| title_full | Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol |
| title_fullStr | Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol |
| title_full_unstemmed | Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol |
| title_short | Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol |
| title_sort | active case detection and treatment of malaria in pregnancy using lamp technology lampreg a pragmatic randomised diagnostic outcomes trial study protocol |
| url | https://bmjopen.bmj.com/content/12/7/e058397.full |
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