<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754322</url>
  </required_header>
  <id_info>
    <org_study_id>REB17-1335</org_study_id>
    <nct_id>NCT03754322</nct_id>
  </id_info>
  <brief_title>LAMP Detection of Malaria in PREGnancy (LAMPREG) Trial</brief_title>
  <acronym>LAMPREG</acronym>
  <official_title>&quot;LAMPREG TRIAL&quot; Active Case Detection and Treatment of Malaria in Pregnancy Using LAMP Technology: A Pragmatic Randomized Multi-Center Diagnostic Outcomes Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amhara Public Health Institute, Ethiopia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Armauer Hansen Research Institute, Ethiopia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The aim of this study is to evaluate the impact of enhanced malaria cases&#xD;
      detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a&#xD;
      prospective study design.&#xD;
&#xD;
      A pragmatic randomized control diagnostic trial will be conducted from October 2020 until&#xD;
      March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic&#xD;
      first and early second trimester pregnant women will be included in the study and&#xD;
      individually randomized to either standard of care or enhanced cased detection arms using&#xD;
      LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing&#xD;
      the peak transmission seasons and then followed until delivery. In the standard of care arm,&#xD;
      venous blood sample will be collected from each study participant and the presence of&#xD;
      Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women&#xD;
      who test positive for malaria will be referred and treated for malaria with quinine or&#xD;
      artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm,&#xD;
      mothers who are symptomatic or asymptomatic will be tested by a commercially available&#xD;
      CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated&#xD;
      if positive by any test. Pregnant mothers who require treatment will be referred and treated&#xD;
      with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The&#xD;
      primary outcome is the proportion of deliveries with low birth weight based on WHO&#xD;
      definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal&#xD;
      hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and&#xD;
      (vi) prematurity in each arm of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malaria in pregnancy often results in high degree of morbidity and mortality of the pregnant&#xD;
      mother and the fetus. Early and accurate diagnosis of subclinical infections will be critical&#xD;
      to malaria elimination and specifically the goals of the World Health Organization to reduce&#xD;
      the burden of disease by 90% before 2030. This goal can only be achieved using highly&#xD;
      sensitive methods such as LAMP that are capable of detecting subclinical infections with very&#xD;
      low parasitemia. Currently both Giemsa stained blood film microscopy and RDT are the only&#xD;
      laboratory methods that are used to diagnose malaria both in pregnant mothers and the general&#xD;
      population. This leaves a big gap in the detection of low-level infections and asymptomatic&#xD;
      malaria due to the documented lack of sensitivity of the aforementioned methods. This, in&#xD;
      turn, predisposes pregnant mothers to malaria-related complications that endangers the life&#xD;
      of the mother and the fetus. In this study, we propose that the use of a highly sensitive&#xD;
      LAMP technique will enable us to detect more asymptomatic Plasmodium infections in pregnant&#xD;
      women. This consequently results in early treatment of the pregnant mothers and may avert&#xD;
      maternal and fetal morbidity and mortality. This study is of particular importance in&#xD;
      Ethiopia where IPT is not used for pregnant women and therefore accurate screening is&#xD;
      paramount.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      General objective To assess the impact of LAMP in the diagnosis of malaria in pregnancy and&#xD;
      its potential role in reducing mortality and morbidity attributable to malaria. We&#xD;
      hypothesize that the additional sensitivity of LAMP coupled with active case detection in&#xD;
      detecting malaria in pregnancy will result in additional cases being identified and treated.&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
        1. To evaluate the impact of LAMP versus microscopy/RDT for the detection of malaria in&#xD;
           pregnant mothers in terms maternal and infant morbidity and mortality.&#xD;
&#xD;
        2. To evaluate the impact of enhanced case detection of malaria in pregnancy by screening&#xD;
           asymptomatic mothers at each antenatal visit until delivery.&#xD;
&#xD;
        3. To determine the impact of treating LAMP-positive asymptomatic and symptomatic pregnant&#xD;
           women as compared to standard of care. Treatment is per national guidelines.&#xD;
&#xD;
      MATERIALS AND METHODS&#xD;
&#xD;
      Study area The study will be conducted at sites across several sites in Ethiopia to obtain&#xD;
      sufficient enrolment and spanning different transmission settings based on epidemiological&#xD;
      data provided by the Federal Ministry of Health. The study sites are in the Amhara region&#xD;
      (Chisabay Health center, Hamusit health center and Andasa Health center), and in the Jimma&#xD;
      area (Bonga (GebreTsadik Shawo) General hospital, Uffa health center and Lare health center).&#xD;
      In Ethiopia, malaria is characterized by its seasonality where the peak transmission season&#xD;
      is from October to December with a second peak in June. P. falciparum and P. vivax are the&#xD;
      predominant species in the area.&#xD;
&#xD;
      Study design and period&#xD;
&#xD;
      The study is a prospective diagnostic study of malaria in pregnant women. The goal is to&#xD;
      determine whether: (i) LAMP provides a clinically measurable benefit compared to current&#xD;
      first line diagnostic test of Giemsa-stained microscopy and whether (ii) enhanced case&#xD;
      detection of asymptomatic mothers with LAMP has added value in terms of outcomes. We&#xD;
      hypothesize that addition of LAMP to one arm will be of greater benefit than microscopy alone&#xD;
      due to additional LAMP sensitivity. We further hypothesize that enhanced case detection by&#xD;
      screening asymptomatic mothers at each antenatal visit will be of additional value in&#xD;
      treating malaria. Both symptomatic and asymptomatic first and second trimester mothers will&#xD;
      be included in the study and individually randomized to one of two arms: standard of care or&#xD;
      enhanced cased detection arms using LAMP for malaria. Mothers will be enrolled during a&#xD;
      seven-month period from June 2021 to January 2022 and then followed until 28 days after&#xD;
      delivery. Given the rate of pregnant mothers at the locations, we anticipate that the&#xD;
      required minimum of 2583 mothers will be enrolled in the study during the study period. In&#xD;
      the first standard of care arm, venous blood sample will be collected from each study&#xD;
      participant and the presence of Plasmodium infection will be diagnosed by microscopy in&#xD;
      symptomatic patients. Pregnant women who test positive for malaria will be referred and&#xD;
      treated for malaria with quinine or ACTs as per national guidelines. In the second (test)&#xD;
      arm, mothers whether symptomatic or asymptomatic will be tested by a commercially available&#xD;
      CE-approved LAMP malaria test (Human Diagnostics LoopAMP (Wiesbaden, Germany)) at each clinic&#xD;
      visit in addition to RDT/microscopy. The commercial LAMP tests can distinguish P. falciparum&#xD;
      and P. vivax and treatment will be given according to national guidelines. The purpose of&#xD;
      doing all tests in the intervention arm is to determine how many additional cases LAMP&#xD;
      identified. The primary outcome is the proportion of deliveries with low birth weight, with&#xD;
      secondary outcomes of: (i) absolute birth weight; (ii) maternal hemoglobin; (ii) neonatal&#xD;
      hemoglobin at birth (Standard Hgb testing from peripheral blood or finger prick); (iv)&#xD;
      neonatal mortality; (v) pregnancy loss; and (vi) prematurity in each of the two arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 18, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of deliveries with low birth weight</measure>
    <time_frame>At the head to toe assessment of the baby within 24 hours of delivery</time_frame>
    <description>Birth weight will be considered as low if &lt; 2500 g</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute birth weight</measure>
    <time_frame>At the head to toe assessment of the baby within 24 hours of delivery</time_frame>
    <description>Birth weight in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal hemoglobin</measure>
    <time_frame>During the pregnancy and at delivery</time_frame>
    <description>Maternal hemoglobin in g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal hemoglobin at birth</measure>
    <time_frame>At the head to toe assessment of the baby within 24 hours of delivery</time_frame>
    <description>Foetal hemoglobin in g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of fetal loss</measure>
    <time_frame>During the study time, for each inclusion until delivery</time_frame>
    <description>Early stillbirth &lt; 20-27 completed weeks of pregnancy Late stillbirth 28 -36 weeks of pregnancy Term still birth &gt; 37 weeks of pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prematurity</measure>
    <time_frame>At delivery</time_frame>
    <description>Baby born Extremely preterm &lt; 28 weeks of pregnancy Very preterm 28-32 weeks of pregnancy Moderate to late preterm 32-37 weeks of pregnancy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Performance of diagnosis methods compared to qRT-PCR as a gold standard</measure>
    <time_frame>At the end of the study</time_frame>
    <description>Evaluation of the sensitivity, specificity, PPV and NPV for LAMP, RDT and microscopy in the study</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of the development of placental malaria</measure>
    <time_frame>At delivery and post hoc</time_frame>
    <description>Evaluation of the presence of malaria pigment in macrophages from placental blood. qPCR in placenta blood</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2583</enrollment>
  <condition>Malaria</condition>
  <condition>Pregnancy Malaria</condition>
  <condition>Malaria in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One third of individuals get allocated to the standard of care arm. At each antenatal visit as per Ethiopian guidelines, pregnant women enrolled in the study will be submitted to the standard of care for malaria in pregnancy. If the pregnant mothers are symptomatic for malaria, they receive microscopy (blood smear for Plasmodium detection) and then are treated with anti-malarial therapy if microscopy is positive for Plasmodium. If it is negative they receive no treatment. If they are asymptomatic, they do not receive any further investigations or treatment in relation to malaria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The remaining two-thirds of participants will be actively screened (symptomatic and asymptomatic) for Plasmodium infection at each antenatal visit, using both LAMP and conventional techniques (microscopy and RDT). If either is positive, participants will be treated with antimalarial therapy according to Ethiopian Ministry of Health guidelines. If both are negative then they receive no treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>LAMP</intervention_name>
    <description>LAMP testing involves taking a blood specimen using venous puncture, extracting DNA and performing a commercial CE-marked LAMP malaria assay to obtain a malaria result (presence/absence of parasite DNA) at the species level</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Microscopy/RDT</intervention_name>
    <description>Standard of care management of malaria in pregnancy relies on microscopy and/or RDT for diagnosis</description>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a pregnant woman in the first or second trimester at time of enrollment&#xD;
&#xD;
          -  Consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman in the third trimester at time of enrollment&#xD;
&#xD;
          -  Multiparity&#xD;
&#xD;
          -  Severe malaria at inclusion as per WHO criteria&#xD;
&#xD;
          -  At risk pregnancy as per Ethiopian guidelines&#xD;
&#xD;
          -  Impossibility to date pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dylan Pillai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dylan Pillai, MD, PhD</last_name>
    <phone>403-770-3578</phone>
    <email>drpillai@ucalgary.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2L 2K8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Amhara Public Health Institute</name>
      <address>
        <city>Bahir Dar</city>
        <state>Amhara</state>
        <country>Ethiopia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Banchamlak Tegegne, MSc</last_name>
      <phone>+251582201698</phone>
      <email>banteg92@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tropical &amp; Infectious Diseases Research Center (TIDRC), Jimma University</name>
      <address>
        <city>Jimma</city>
        <state>Oromia</state>
        <country>Ethiopia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Armauer Hansen Research Institute, Ethiopia</name>
      <address>
        <city>Addis Ababa</city>
        <country>Ethiopia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mekonnen Teferi, PhD</last_name>
      <phone>251-13483752</phone>
      <email>mekonnen.teferi@ahri.gov.et</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Dylan R Pillai</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Plasmodium</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Malaria</keyword>
  <keyword>LAMP</keyword>
  <keyword>Asymptomatic infections</keyword>
  <keyword>Low Birth Weight</keyword>
  <keyword>Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03754322/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03754322/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754322
org study id: REB17-1335
nct id: NCT03754322
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Objective: The aim of this study is to evaluate the impact of enhanced malaria cases
      detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a
      prospective study design.

      A pragmatic randomized control diagnostic trial will be conducted from October 2020 until
      March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic
      first and early second trimester pregnant women will be included in the study and
      individually randomized to either standard of care or enhanced cased detection arms using
      LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing
      the peak transmission seasons and then followed until delivery. In the standard of care arm,
      venous blood sample will be collected from each study participant and the presence of
      Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women
      who test positive for malaria will be referred and treated for malaria with quinine or
      artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm,
      mothers who are symptomatic or asymptomatic will be tested by a commercially available
      CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated
      if positive by any test. Pregnant mothers who require treatment will be referred and treated
      with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The
      primary outcome is the proportion of deliveries with low birth weight based on WHO
      definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal
      hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and
      (vi) prematurity in each arm of the study.
Malaria in pregnancy often results in high degree of morbidity and mortality of the pregnant
      mother and the fetus. Early and accurate diagnosis of subclinical infections will be critical
      to malaria elimination and specifically the goals of the World Health Organization to reduce
      the burden of disease by 90% before 2030. This goal can only be achieved using highly
      sensitive methods such as LAMP that are capable of detecting subclinical infections with very
      low parasitemia. Currently both Giemsa stained blood film microscopy and RDT are the only
      laboratory methods that are used to diagnose malaria both in pregnant mothers and the general
      population. This leaves a big gap in the detection of low-level infections and asymptomatic
      malaria due to the documented lack of sensitivity of the aforementioned methods. This, in
      turn, predisposes pregnant mothers to malaria-related complications that endangers the life
      of the mother and the fetus. In this study, we propose that the use of a highly sensitive
      LAMP technique will enable us to detect more asymptomatic Plasmodium infections in pregnant
      women. This consequently results in early treatment of the pregnant mothers and may avert
      maternal and fetal morbidity and mortality. This study is of particular importance in
      Ethiopia where IPT is not used for pregnant women and therefore accurate screening is
      paramount.

      OBJECTIVES

      General objective To assess the impact of LAMP in the diagnosis of malaria in pregnancy and
      its potential role in reducing mortality and morbidity attributable to malaria. We
      hypothesize that the additional sensitivity of LAMP coupled with active case detection in
      detecting malaria in pregnancy will result in additional cases being identified and treated.

      Specific objectives

        1. To evaluate the impact of LAMP versus microscopy/RDT for the detection of malaria in
           pregnant mothers in terms maternal and infant morbidity and mortality.

        2. To evaluate the impact of enhanced case detection of malaria in pregnancy by screening
           asymptomatic mothers at each antenatal visit until delivery.

        3. To determine the impact of treating LAMP-positive asymptomatic and symptomatic pregnant
           women as compared to standard of care. Treatment is per national guidelines.

      MATERIALS AND METHODS

      Study area The study will be conducted at sites across several sites in Ethiopia to obtain
      sufficient enrolment and spanning different transmission settings based on epidemiological
      data provided by the Federal Ministry of Health. The study sites are in the Amhara region
      (Chisabay Health center, Hamusit health center and Andasa Health center), and in the Jimma
      area (Bonga (GebreTsadik Shawo) General hospital, Uffa health center and Lare health center).
      In Ethiopia, malaria is characterized by its seasonality where the peak transmission season
      is from October to December with a second peak in June. P. falciparum and P. vivax are the
      predominant species in the area.

      Study design and period

      The study is a prospective diagnostic study of malaria in pregnant women. The goal is to
      determine whether: (i) LAMP provides a clinically measurable benefit compared to current
      first line diagnostic test of Giemsa-stained microscopy and whether (ii) enhanced case
      detection of asymptomatic mothers with LAMP has added value in terms of outcomes. We
      hypothesize that addition of LAMP to one arm will be of greater benefit than microscopy alone
      due to additional LAMP sensitivity. We further hypothesize that enhanced case detection by
      screening asymptomatic mothers at each antenatal visit will be of additional value in
      treating malaria. Both symptomatic and asymptomatic first and second trimester mothers will
      be included in the study and individually randomized to one of two arms: standard of care or
      enhanced cased detection arms using LAMP for malaria. Mothers will be enrolled during a
      seven-month period from June 2021 to January 2022 and then followed until 28 days after
      delivery. Given the rate of pregnant mothers at the locations, we anticipate that the
      required minimum of 2583 mothers will be enrolled in the study during the study period. In
      the first standard of care arm, venous blood sample will be collected from each study
      participant and the presence of Plasmodium infection will be diagnosed by microscopy in
      symptomatic patients. Pregnant women who test positive for malaria will be referred and
      treated for malaria with quinine or ACTs as per national guidelines. In the second (test)
      arm, mothers whether symptomatic or asymptomatic will be tested by a commercially available
      CE-approved LAMP malaria test (Human Diagnostics LoopAMP (Wiesbaden, Germany)) at each clinic
      visit in addition to RDT/microscopy. The commercial LAMP tests can distinguish P. falciparum
      and P. vivax and treatment will be given according to national guidelines. The purpose of
      doing all tests in the intervention arm is to determine how many additional cases LAMP
      identified. The primary outcome is the proportion of deliveries with low birth weight, with
      secondary outcomes of: (i) absolute birth weight; (ii) maternal hemoglobin; (ii) neonatal
      hemoglobin at birth (Standard Hgb testing from peripheral blood or finger prick); (iv)
      neonatal mortality; (v) pregnancy loss; and (vi) prematurity in each of the two arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Proportion of deliveries with low birth weight
time frame: At the head to toe assessment of the baby within 24 hours of delivery
description: Birth weight will be considered as low if < 2500 g
measure: Absolute birth weight
time frame: At the head to toe assessment of the baby within 24 hours of delivery
description: Birth weight in grams
measure: Maternal hemoglobin
time frame: During the pregnancy and at delivery
description: Maternal hemoglobin in g/dL
measure: Neonatal hemoglobin at birth
time frame: At the head to toe assessment of the baby within 24 hours of delivery
description: Foetal hemoglobin in g/dL
measure: Proportion of fetal loss
time frame: During the study time, for each inclusion until delivery
description: Early stillbirth < 20-27 completed weeks of pregnancy Late stillbirth 28 -36 weeks of pregnancy Term still birth > 37 weeks of pregnancy
measure: Prematurity
time frame: At delivery
description: Baby born Extremely preterm < 28 weeks of pregnancy Very preterm 28-32 weeks of pregnancy Moderate to late preterm 32-37 weeks of pregnancy
measure: Performance of diagnosis methods compared to qRT-PCR as a gold standard
time frame: At the end of the study
description: Evaluation of the sensitivity, specificity, PPV and NPV for LAMP, RDT and microscopy in the study
measure: Assessment of the development of placental malaria
time frame: At delivery and post hoc
description: Evaluation of the presence of malaria pigment in macrophages from placental blood. qPCR in placenta blood
arm group label: Standard of care
arm group type: Active Comparator
description: One third of individuals get allocated to the standard of care arm. At each antenatal visit as per Ethiopian guidelines, pregnant women enrolled in the study will be submitted to the standard of care for malaria in pregnancy. If the pregnant mothers are symptomatic for malaria, they receive microscopy (blood smear for Plasmodium detection) and then are treated with anti-malarial therapy if microscopy is positive for Plasmodium. If it is negative they receive no treatment. If they are asymptomatic, they do not receive any further investigations or treatment in relation to malaria.
arm group label: Intervention arm
arm group type: Experimental
description: The remaining two-thirds of participants will be actively screened (symptomatic and asymptomatic) for Plasmodium infection at each antenatal visit, using both LAMP and conventional techniques (microscopy and RDT). If either is positive, participants will be treated with antimalarial therapy according to Ethiopian Ministry of Health guidelines. If both are negative then they receive no treatment.
intervention type: Diagnostic Test
intervention name: LAMP
description: LAMP testing involves taking a blood specimen using venous puncture, extracting DNA and performing a commercial CE-marked LAMP malaria assay to obtain a malaria result (presence/absence of parasite DNA) at the species level
arm group label: Intervention arm
intervention type: Diagnostic Test
intervention name: Microscopy/RDT
description: Standard of care management of malaria in pregnancy relies on microscopy and/or RDT for diagnosis
arm group label: Intervention arm
arm group label: Standard of care
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women only
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dylan Pillai, MD, PhD
role: Principal Investigator
affiliation: University of Calgary
last name: Dylan Pillai, MD, PhD
phone: 403-770-3578
email: drpillai@ucalgary.ca
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
contact: 
country: Canada
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Dylan R Pillai
investigator title: Professor
mesh term: Malaria
sharing ipd: No
provided document: 
provided document: 