<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/NCT02974608</url>
  </required_header>
  <id_info>
    <org_study_id>999917018</org_study_id>
    <secondary_id>17-I-N018</secondary_id>
    <nct_id>NCT02974608</nct_id>
  </id_info>
  <brief_title>Impact of Malaria on Pregnant Women in Ouelessebougou, Mali</brief_title>
  <official_title>Demographic Surveillance to Monitor Impact of Malaria on Pregnant Women in Ouelessebougou, Mali</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa,&#xD;
      malaria continues to be the main cause of death in young children and pregnant women.&#xD;
      Researchers want to find out more about how malaria affects pregnant women and their babies.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To study the rate of miscarriage and stillbirth during the second and third trimesters among&#xD;
      women in a certain district in Mali. To study rates of malaria infection over time among&#xD;
      pregnant women and children in this area.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Pregnant women of any age and pregnancy stage and their newborns. They must live in&#xD;
      Ouelessebougou, Mali. Children up to 10 years old who live there.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Information about the study will be shared at community meetings, during visits to the health&#xD;
      centers, and during census updates.&#xD;
&#xD;
      Participants will read and sign a consent form.&#xD;
&#xD;
      Pregnant women will be screened to see if they are eligible. They may have a urine test. They&#xD;
      may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures&#xD;
      of the body.&#xD;
&#xD;
      Women will be enrolled in the study after they have their babies.&#xD;
&#xD;
      Participants may have a physical exam.&#xD;
&#xD;
      Some participants will provide a finger/heel prick blood sample.&#xD;
&#xD;
      Participants will complete a questionnaire. They will be asked about:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Antimalarial and other interventions&#xD;
&#xD;
      Socioeconomic status&#xD;
&#xD;
      Their pregnancy&#xD;
&#xD;
      Previous pregnancies&#xD;
&#xD;
      Health of their newborn...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Placental malaria (PM) leads to poor outcomes for pregnant women and their babies, and is&#xD;
      caused by Plasmodium falciparum sequestration in the intervillous spaces of the placenta and&#xD;
      ensuing inflammation. Severe maternal anemia, low birth weight (LBW) delivery and fetal loss&#xD;
      are common sequelae. Malaria-related LBW alone is estimated to cause 62,000-363,000 infant&#xD;
      deaths in Africa each year. To reduce poor pregnancy outcomes associated with malaria&#xD;
      infection, WHO recommends monthly anti-malarial treatment with sulfadoxine pyrimethamine (SP)&#xD;
      during the second and third trimester and the use of insecticide-treated bed nets. However,&#xD;
      in East and Southern Africa, SP has lost its efficacy due to the spread of drug-resistant&#xD;
      parasites. Therefore, an effective vaccine for PM is needed. Although the ideal vaccine will&#xD;
      be given to adolescent girls prior to becoming pregnant, at this early stage of pregnancy&#xD;
      malaria vaccine development, it is unknown if a boosting dose may be needed during pregnancy.&#xD;
&#xD;
      Before testing new interventions to improve pregnancy outcomes, it is important to obtain&#xD;
      baseline information on pregnancy outcomes in the target population. In our recent&#xD;
      longitudinal study of 1,885 pregnant women in Mali, in which women were closely followed&#xD;
      during pregnancy (including malaria prevention and treatment), 2.9%, 2.4% and 6% of&#xD;
      pregnancies ended in miscarriage, stillbirth, and preterm delivery, respectively.&#xD;
&#xD;
      The primary goal of the study is to assess pregnancy outcomes in women in the community with&#xD;
      access to the WHO recommended standard of care. In the first part of the study, all women&#xD;
      presenting for an antenatal visit at Ouelessebougou health centers will be recruited into the&#xD;
      study. In the second part of the study, non-pregnant women will be enrolled and followed to&#xD;
      capture data on pregnancy outcomes including early pregnancy losses. Pregnancy outcome&#xD;
      information will be collected after the birth of the child or after pregnancy termination&#xD;
      (i.e. miscarriage/stillbirth). Primary and secondary endpoints will be analyzed using&#xD;
      appropriate statistical methods, including possible confounders, to determine the prevalence&#xD;
      and factors associated with poor pregnancy outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">April 21, 2022</completion_date>
  <primary_completion_date type="Actual">October 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of malaria infection</measure>
    <time_frame>Semi-annual</time_frame>
    <description>Rates of malaria infections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the rate of fetal loss during the 2nd and 3rd trimesters</measure>
    <time_frame>Annual</time_frame>
    <description>Rates of fetal losses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the prevalence rate of SP resistant parasites</measure>
    <time_frame>Annual</time_frame>
    <description>Rate of SP resistant parasites (in vivo and molecular markers)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the rate of pre-term and low birth weight deliveries</measure>
    <time_frame>Annual</time_frame>
    <description>Number of pre-term deliveries, low birthweight deliveries, neonatal mortality</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">7691</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>Children 0-10 years</arm_group_label>
    <description>Children living in selected villages surrounding the district of Ouelessebougou</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant Women + Newborns</arm_group_label>
    <description>Pregnant women of any age and their newborn children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women of Child Bearing Age Potential</arm_group_label>
    <description>Non-pregnant women of child-bearing age</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Study population from which the cohorts will be selected live in selected villages&#xD;
        surrounding the districts of Ouelessebougou, Mali&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        A study participant must satisfy the following criteria to be enrolled in this study:&#xD;
&#xD;
          1. Pregnant women and their newborn cohort: Pregnant women of any age and pregnancy stage&#xD;
             and their newborns residing in the study area&#xD;
&#xD;
          2. women of child-bearing age cohort: women who are not under contraception or&#xD;
             breastfeeding for less than 12 months and planning to become pregnant, and their&#xD;
             newborn once they become pregnant&#xD;
&#xD;
          3. Children between the ages of 0-10 years residing in the study area&#xD;
&#xD;
          4. The study participant or parent/guardian understands the study and is able to provide&#xD;
             informed consent for themselves and/or their child.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Temporary residence in the study area&#xD;
&#xD;
          2. Conditions that in the judgment of the investigator could impair the ability of the&#xD;
             participants to understand the study or comply with the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michal Fried, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ouelessebougou Clinical Research Center (Malaria Research and Training Center)</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <verification_date>March 21, 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Placental</keyword>
  <keyword>Fetal Loss</keyword>
  <keyword>Observational</keyword>
  <keyword>Antenatal</keyword>
  <keyword>Infection</keyword>
  <keyword>Natural History</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/NCT02974608
org study id: 999917018
secondary id: 17-I-N018
nct id: NCT02974608
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa,
      malaria continues to be the main cause of death in young children and pregnant women.
      Researchers want to find out more about how malaria affects pregnant women and their babies.

      Objectives:

      To study the rate of miscarriage and stillbirth during the second and third trimesters among
      women in a certain district in Mali. To study rates of malaria infection over time among
      pregnant women and children in this area.

      Eligibility:

      Pregnant women of any age and pregnancy stage and their newborns. They must live in
      Ouelessebougou, Mali. Children up to 10 years old who live there.

      Design:

      Information about the study will be shared at community meetings, during visits to the health
      centers, and during census updates.

      Participants will read and sign a consent form.

      Pregnant women will be screened to see if they are eligible. They may have a urine test. They
      may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures
      of the body.

      Women will be enrolled in the study after they have their babies.

      Participants may have a physical exam.

      Some participants will provide a finger/heel prick blood sample.

      Participants will complete a questionnaire. They will be asked about:

      Medical history

      Antimalarial and other interventions

      Socioeconomic status

      Their pregnancy

      Previous pregnancies

      Health of their newborn...
Placental malaria (PM) leads to poor outcomes for pregnant women and their babies, and is
      caused by Plasmodium falciparum sequestration in the intervillous spaces of the placenta and
      ensuing inflammation. Severe maternal anemia, low birth weight (LBW) delivery and fetal loss
      are common sequelae. Malaria-related LBW alone is estimated to cause 62,000-363,000 infant
      deaths in Africa each year. To reduce poor pregnancy outcomes associated with malaria
      infection, WHO recommends monthly anti-malarial treatment with sulfadoxine pyrimethamine (SP)
      during the second and third trimester and the use of insecticide-treated bed nets. However,
      in East and Southern Africa, SP has lost its efficacy due to the spread of drug-resistant
      parasites. Therefore, an effective vaccine for PM is needed. Although the ideal vaccine will
      be given to adolescent girls prior to becoming pregnant, at this early stage of pregnancy
      malaria vaccine development, it is unknown if a boosting dose may be needed during pregnancy.

      Before testing new interventions to improve pregnancy outcomes, it is important to obtain
      baseline information on pregnancy outcomes in the target population. In our recent
      longitudinal study of 1,885 pregnant women in Mali, in which women were closely followed
      during pregnancy (including malaria prevention and treatment), 2.9%, 2.4% and 6% of
      pregnancies ended in miscarriage, stillbirth, and preterm delivery, respectively.

      The primary goal of the study is to assess pregnancy outcomes in women in the community with
      access to the WHO recommended standard of care. In the first part of the study, all women
      presenting for an antenatal visit at Ouelessebougou health centers will be recruited into the
      study. In the second part of the study, non-pregnant women will be enrolled and followed to
      capture data on pregnancy outcomes including early pregnancy losses. Pregnancy outcome
      information will be collected after the birth of the child or after pregnancy termination
      (i.e. miscarriage/stillbirth). Primary and secondary endpoints will be analyzed using
      appropriate statistical methods, including possible confounders, to determine the prevalence
      and factors associated with poor pregnancy outcomes.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of malaria infection
time frame: Semi-annual
description: Rates of malaria infections
measure: Assess the rate of fetal loss during the 2nd and 3rd trimesters
time frame: Annual
description: Rates of fetal losses
measure: Assess the prevalence rate of SP resistant parasites
time frame: Annual
description: Rate of SP resistant parasites (in vivo and molecular markers)
measure: Assess the rate of pre-term and low birth weight deliveries
time frame: Annual
description: Number of pre-term deliveries, low birthweight deliveries, neonatal mortality
arm group label: Children 0-10 years
description: Children living in selected villages surrounding the district of Ouelessebougou
arm group label: Pregnant Women + Newborns
description: Pregnant women of any age and their newborn children
arm group label: Women of Child Bearing Age Potential
description: Non-pregnant women of child-bearing age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michal Fried, Ph.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: Mali
responsible party type: Sponsor
mesh term: Malaria