<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/NCT04412005</url>
  </required_header>
  <id_info>
    <org_study_id>1R01AI123050</org_study_id>
    <nct_id>NCT04412005</nct_id>
  </id_info>
  <brief_title>Pregnant Women for Malaria Surveillance</brief_title>
  <acronym>MiPMon</acronym>
  <official_title>Pregnant Women as a Sentinel Group for Malaria Surveillance in an Era of Changing Malaria Transmission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barcelona Institute for Global Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barcelona Institute for Global Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Close monitoring of malaria in pregnancy can help to quickly identify changes in malaria&#xD;
      burden and related adverse outcomes, especially in areas embarking in malaria elimination&#xD;
      activities. The easy access of pregnant women through antenatal clinics, combined with the&#xD;
      potential of pregnancy-specific serology to assess cumulative exposure to malaria, can&#xD;
      provide the basis for new sentinel surveillance methods. Such an approach has the potential&#xD;
      to guide clinical practice and the choice of malaria control/preventive tools adapted to&#xD;
      areas of different transmission intensity, as well as to generate sensitive metrics of&#xD;
      transmission during malaria elimination activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Continued monitoring of malaria in pregnancy is lacking in most endemic settings, in spite of&#xD;
      its significant disease burden. Increases in malaria-related harmful effects observed among&#xD;
      Mozambican pregnant women after drastic malaria declines during the last decade [2] suggest&#xD;
      that closely monitoring of the transmission is needed to quickly identify rebounds in adverse&#xD;
      outcomes, especially in areas embarking in malaria elimination activities. Moreover, several&#xD;
      evidences point to IgGs against VAR2CSA (the parasite antigen that mediates sequestration of&#xD;
      P. falciparum in the placenta) as a marker of cumulative exposure to P. falciparum during&#xD;
      pregnancy that can provide estimates of malaria transmission. The investigators hypothesize&#xD;
      that dynamics of malaria in pregnancy and pregnancy-specific immunity reflect changes in the&#xD;
      intensity of transmission through location and time, not only among pregnant women but also&#xD;
      in the underlying community. The goal of this study is to provide epidemiological, molecular&#xD;
      and immunological insights of the value of pregnant women attending health facilities to&#xD;
      generate estimates of malaria burden and its adverse consequences in situation of varying&#xD;
      levels of malaria transmission, with the ultimate hope of developing new tools for the&#xD;
      monitoring of malaria in endemic countries. To address this, the investigators will conduct a&#xD;
      three-year prospective observational study at three health facilities with different levels&#xD;
      of malaria transmission in Maputo Province to determine the relationship between malaria&#xD;
      transmission, parasitological outcomes and the clinical impact of malaria infection in&#xD;
      pregnant women at their first antenatal visit, delivery and during sick visits (Aim 1.1).&#xD;
      Moreover, the investigators will create a sample repository biobank for future investigations&#xD;
      on host and parasite factors influencing malaria disease during pregnancy (Aim 1.2). The&#xD;
      investigators will also determine the relationship between malaria estimates obtained from&#xD;
      pregnant women, children at hospital visits, (Aim 2.1) and seroprevalences against VAR2CSA&#xD;
      (Aim 2.2). The impact of interrupting malaria transmission on pregnancy-specific serology&#xD;
      (Aim 2.3) will be assessed in pregnant women from Magude after mass drug administration in&#xD;
      the community. Finally, scientific capacity in the Manhiça Health Research Center (Aim 3)&#xD;
      will be developed through training on a) epidemiological research and management of malaria&#xD;
      data; b) molecular tools for detection of malaria parasites and molecular markers of&#xD;
      antimalarial resistance for rapid mapping of drug resistance; and c) pregnancy-specific&#xD;
      immunity as an innovative tool to assess malaria transmission. This study will contribute to&#xD;
      promote a pregnancy malaria research agenda by improving our scientific knowledge on&#xD;
      determinants of malaria susceptibility during pregnancy and demonstrating the feasibility and&#xD;
      value of an easy-to-implement new generation serological tool for malaria surveillance in&#xD;
      malaria elimination contexts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pregnant women with a P. falciparum infection</measure>
    <time_frame>3 years</time_frame>
    <description>P. falciparum detected by qPCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of pregnant women with maternal anemia</measure>
    <time_frame>3 years</time_frame>
    <description>Hemoglobin levels (Hemocue)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pregnant women delivering a newborn with low birthweight</measure>
    <time_frame>3 years</time_frame>
    <description>grams in a digital scale</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">16958</enrollment>
  <condition>P. Falciparum</condition>
  <arm_group>
    <arm_group_label>Manhiça</arm_group_label>
    <description>Pregnant women attending the Manhiça District Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ilha Josina</arm_group_label>
    <description>Pregnant women attending the Ilha Josina Health Center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magude</arm_group_label>
    <description>Pregnant women attending the Magude Health Center</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Ilha Josina</arm_group_label>
    <arm_group_label>Magude</arm_group_label>
    <arm_group_label>Manhiça</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Dried blood spots Plasma and PBMCS from a random selection of study participants&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending three health centers in areas of Maputo Province with different&#xD;
        levels of malaria transmission (Manhiça District Hospital [Manhiça District], Ilha Josina&#xD;
        Health Center [Manhiça District] and Magude Health Center [Magude District])&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women attending their first routine ANCs or pregnant women seen at the moment&#xD;
             of delivery or pregnant women with signs/symptoms of malaria (axillary temperature ≥&#xD;
             37.5°C, referred history of fever in the last 24 hours, pallor, arthromyalgias,&#xD;
             headache and/or history of convulsions)&#xD;
&#xD;
          -  Being equal or older than 16 years&#xD;
&#xD;
          -  Being from the study area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the study or to have samples obtained&#xD;
&#xD;
          -  Not being from the study area.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Being pregnant</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malaria</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>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04412005
org study id: 1R01AI123050
nct id: NCT04412005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Close monitoring of malaria in pregnancy can help to quickly identify changes in malaria
      burden and related adverse outcomes, especially in areas embarking in malaria elimination
      activities. The easy access of pregnant women through antenatal clinics, combined with the
      potential of pregnancy-specific serology to assess cumulative exposure to malaria, can
      provide the basis for new sentinel surveillance methods. Such an approach has the potential
      to guide clinical practice and the choice of malaria control/preventive tools adapted to
      areas of different transmission intensity, as well as to generate sensitive metrics of
      transmission during malaria elimination activities.
Continued monitoring of malaria in pregnancy is lacking in most endemic settings, in spite of
      its significant disease burden. Increases in malaria-related harmful effects observed among
      Mozambican pregnant women after drastic malaria declines during the last decade [2] suggest
      that closely monitoring of the transmission is needed to quickly identify rebounds in adverse
      outcomes, especially in areas embarking in malaria elimination activities. Moreover, several
      evidences point to IgGs against VAR2CSA (the parasite antigen that mediates sequestration of
      P. falciparum in the placenta) as a marker of cumulative exposure to P. falciparum during
      pregnancy that can provide estimates of malaria transmission. The investigators hypothesize
      that dynamics of malaria in pregnancy and pregnancy-specific immunity reflect changes in the
      intensity of transmission through location and time, not only among pregnant women but also
      in the underlying community. The goal of this study is to provide epidemiological, molecular
      and immunological insights of the value of pregnant women attending health facilities to
      generate estimates of malaria burden and its adverse consequences in situation of varying
      levels of malaria transmission, with the ultimate hope of developing new tools for the
      monitoring of malaria in endemic countries. To address this, the investigators will conduct a
      three-year prospective observational study at three health facilities with different levels
      of malaria transmission in Maputo Province to determine the relationship between malaria
      transmission, parasitological outcomes and the clinical impact of malaria infection in
      pregnant women at their first antenatal visit, delivery and during sick visits (Aim 1.1).
      Moreover, the investigators will create a sample repository biobank for future investigations
      on host and parasite factors influencing malaria disease during pregnancy (Aim 1.2). The
      investigators will also determine the relationship between malaria estimates obtained from
      pregnant women, children at hospital visits, (Aim 2.1) and seroprevalences against VAR2CSA
      (Aim 2.2). The impact of interrupting malaria transmission on pregnancy-specific serology
      (Aim 2.3) will be assessed in pregnant women from Magude after mass drug administration in
      the community. Finally, scientific capacity in the Manhiça Health Research Center (Aim 3)
      will be developed through training on a) epidemiological research and management of malaria
      data; b) molecular tools for detection of malaria parasites and molecular markers of
      antimalarial resistance for rapid mapping of drug resistance; and c) pregnancy-specific
      immunity as an innovative tool to assess malaria transmission. This study will contribute to
      promote a pregnancy malaria research agenda by improving our scientific knowledge on
      determinants of malaria susceptibility during pregnancy and demonstrating the feasibility and
      value of an easy-to-implement new generation serological tool for malaria surveillance in
      malaria elimination contexts.
observational model: Other
time perspective: Prospective
measure: Number of pregnant women with a P. falciparum infection
time frame: 3 years
description: P. falciparum detected by qPCR
measure: Number of pregnant women with maternal anemia
time frame: 3 years
description: Hemoglobin levels (Hemocue)
measure: Number of pregnant women delivering a newborn with low birthweight
time frame: 3 years
description: grams in a digital scale
arm group label: Manhiça
description: Pregnant women attending the Manhiça District Hospital
arm group label: Ilha Josina
description: Pregnant women attending the Ilha Josina Health Center
arm group label: Magude
description: Pregnant women attending the Magude Health Center
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Ilha Josina
arm group label: Magude
arm group label: Manhiça
Dried blood spots Plasma and PBMCS from a random selection of study participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Being pregnant
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Malaria
sharing ipd: Undecided