<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/NCT01703884</url>
  </required_header>
  <id_info>
    <org_study_id>B00531</org_study_id>
    <nct_id>NCT01703884</nct_id>
  </id_info>
  <brief_title>ANC &amp; Malaria Diagnostic in Pregnancy</brief_title>
  <acronym>AQUAMOD</acronym>
  <official_title>Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Muraz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Muraz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The program's overall objective is to assess the impact of a package of interventions aimed&#xD;
      at reducing malaria-related mortality and morbidity in pregnant women and newborns by&#xD;
      ensuring access to a package of interventions designed to optimise the detection and&#xD;
      treatment of malaria during pregnancy as well as improving the early detection and treatment&#xD;
      of malaria during the third trimester.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cluster-randomised study in which the health facility is the unit of randomisation.&#xD;
      16 health facilities will be randomised to intervention and control. At the community level&#xD;
      women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal&#xD;
      visits throughout the pregnancy and deliver at the facility. The current recommended standard&#xD;
      of care will be provided to all women attending antenatal and obstetric care. In the&#xD;
      intervention area, obstetric, medical, drug-exposure histories will be collected at ANC&#xD;
      visits. In addition, in the last trimester of the pregnancy (&gt; 28 weeks of pregnancy), women&#xD;
      will be systematically evaluated with selected diagnostic test for whether they have malaria&#xD;
      parasites and treated effectively. Skilled birth attendants at the facility will be trained&#xD;
      in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low&#xD;
      birth weight and external/observable birth defects. In the control area, women will be&#xD;
      provided with standard practice of care. In both areas, women will be diagnosed and treated&#xD;
      at delivery if they are positive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Placental malaria at delivery</measure>
    <time_frame>9 months</time_frame>
    <description>The main outcome variable of interest will be the proportion of women in each group with placental malaria at delivery (defined as placental biopsies positive for P. falciparum )</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of women with peripheral positive malaria infection at delivery</measure>
    <time_frame>9 months</time_frame>
    <description>The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The proportion of women with severe anaemia in women at delivery</measure>
    <time_frame>9 months</time_frame>
    <description>The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg &lt;8 g/dL),</description>
  </other_outcome>
  <other_outcome>
    <measure>Low Birth Weight</measure>
    <time_frame>9 months</time_frame>
    <description>Low Birth Weight (defined as &lt;2500g)</description>
  </other_outcome>
  <other_outcome>
    <measure>Stillbirth</measure>
    <time_frame>28 weeks of gestation</time_frame>
    <description>Stillbirth (defined as dead birth after 28 weeks of gestation)</description>
  </other_outcome>
  <other_outcome>
    <measure>Perinatal and early neonatal deaths</measure>
    <time_frame>7 days post delivery</time_frame>
    <description>Perinatal and early neonatal deaths (i.e. death within 7 days of birth)</description>
  </other_outcome>
  <other_outcome>
    <measure>External/observable birth defects</measure>
    <time_frame>9 months</time_frame>
    <description>Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal death</measure>
    <time_frame>42 days post delivery</time_frame>
    <description>Maternal death (death within 42 days of delivery, regardless of cause)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5254</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>ASAQ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At ANC and labor wards for women in the control area, there will be no change from routine approaches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASAQ</intervention_name>
    <description>In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (&gt; 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.</description>
    <arm_group_label>ASAQ</arm_group_label>
    <other_name>Coarsucam, ASAQ Winthrop</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Located in the geographical location of Dafra &amp; Do district&#xD;
&#xD;
          -  Have a minimum attendance of 200 pregnant women per year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other public health facilities, private clinics and Dafra District Hospital will be&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halidou Tinto, PharmD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>centre muraz - irss</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dafra &amp; Do districts</name>
      <address>
        <city>Bobo-Dioulasso</city>
        <state>Hauts Bassins-houet</state>
        <zip>01</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>July 29, 2015</last_update_submitted>
  <last_update_submitted_qc>July 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Muraz</investigator_affiliation>
    <investigator_full_name>Tinto Halidou</investigator_full_name>
    <investigator_title>PharmD, Msc, PhD</investigator_title>
  </responsible_party>
  <keyword>Malria diagnosis</keyword>
  <keyword>Malaria prevention in pregnancy</keyword>
  <keyword>ANC services improvement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <!-- 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/NCT01703884
org study id: B00531
nct id: NCT01703884
lead sponsor: 
collaborator: 
has dmc: No
The program's overall objective is to assess the impact of a package of interventions aimed
      at reducing malaria-related mortality and morbidity in pregnant women and newborns by
      ensuring access to a package of interventions designed to optimise the detection and
      treatment of malaria during pregnancy as well as improving the early detection and treatment
      of malaria during the third trimester.
This is a cluster-randomised study in which the health facility is the unit of randomisation.
      16 health facilities will be randomised to intervention and control. At the community level
      women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal
      visits throughout the pregnancy and deliver at the facility. The current recommended standard
      of care will be provided to all women attending antenatal and obstetric care. In the
      intervention area, obstetric, medical, drug-exposure histories will be collected at ANC
      visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women
      will be systematically evaluated with selected diagnostic test for whether they have malaria
      parasites and treated effectively. Skilled birth attendants at the facility will be trained
      in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low
      birth weight and external/observable birth defects. In the control area, women will be
      provided with standard practice of care. In both areas, women will be diagnosed and treated
      at delivery if they are positive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Placental malaria at delivery
time frame: 9 months
description: The main outcome variable of interest will be the proportion of women in each group with placental malaria at delivery (defined as placental biopsies positive for P. falciparum )
measure: The proportion of women with peripheral positive malaria infection at delivery
time frame: 9 months
description: The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)
measure: The proportion of women with severe anaemia in women at delivery
time frame: 9 months
description: The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL),
measure: Low Birth Weight
time frame: 9 months
description: Low Birth Weight (defined as <2500g)
measure: Stillbirth
time frame: 28 weeks of gestation
description: Stillbirth (defined as dead birth after 28 weeks of gestation)
measure: Perinatal and early neonatal deaths
time frame: 7 days post delivery
description: Perinatal and early neonatal deaths (i.e. death within 7 days of birth)
measure: External/observable birth defects
time frame: 9 months
description: Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.
measure: Maternal death
time frame: 42 days post delivery
description: Maternal death (death within 42 days of delivery, regardless of cause)
arm group label: ASAQ
arm group type: Experimental
description: In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively.
arm group label: SP
arm group type: No Intervention
description: At ANC and labor wards for women in the control area, there will be no change from routine approaches.
intervention type: Drug
intervention name: ASAQ
description: In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.
arm group label: ASAQ
other name: Coarsucam, ASAQ Winthrop
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: No
last name: Halidou Tinto, PharmD, PhD
role: Principal Investigator
affiliation: centre muraz - irss
facility: 
country: Burkina Faso
responsible party type: Principal Investigator
investigator affiliation: Centre Muraz
investigator full name: Tinto Halidou
investigator title: PharmD, Msc, PhD
mesh term: Malaria