<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/NCT04405700</url>
  </required_header>
  <id_info>
    <org_study_id>2002126816</org_study_id>
    <nct_id>NCT04405700</nct_id>
  </id_info>
  <brief_title>Measuring Adverse Pregnancy and Newborn Congenital Outcomes</brief_title>
  <acronym>MANGO</acronym>
  <official_title>Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</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>
      The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to&#xD;
      monitor adverse pregnancy and infant outcomes, including the presence of congenital&#xD;
      abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites&#xD;
      affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In part 1 of this study, the investigators will use a mixed prospective and cross-sectional&#xD;
      cohort study design to implement a PV program at two health facilities affiliated with the&#xD;
      Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators&#xD;
      will analyze these data to examine any associations between antiretroviral treatment (ART)&#xD;
      and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create&#xD;
      standardized protocols and data exchange standards within IeDEA to enable the merging and&#xD;
      analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating&#xD;
      Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and&#xD;
      archiving data from the study in Kenya as well as data collected through a similar, ongoing&#xD;
      study at health facilities in South Africa affiliated with IeDEA. This study will establish a&#xD;
      multiregional PV infrastructure within IeDEA that can be further scaled within the broader&#xD;
      IeDEA network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy outcomes</measure>
    <time_frame>2021-2022</time_frame>
    <description>Live Birth, Still Birth, Miscarriage, Termination of pregnancy, Ectopic Pregnancy, Molar Pregnancy, Not Pregnant, Other); also including pre-term delivery (&lt;37 weeks gestational age) or very pre-term delivery (&lt;32 weeks gestational age)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant/birth outcomes</measure>
    <time_frame>2021-2022</time_frame>
    <description>Congenital abnormalities on newborn surface exam (e.g., extra digit, hydrocephalus, skull defects, eyes, face, mouth/lip/palate, chest, abdomen, anus, limbs, spine (including neural tube defects), hips, genitalia, skin, etc.); also including low birth weight, small for gestational age (&lt;10th percentile) or very small for gestational age (&lt;3rd percentile)</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Pregnancy Related</condition>
  <condition>Congenital Disorders</condition>
  <condition>Newborn Morbidity</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (C1)</arm_group_label>
    <description>Prospective recruitment of pregnant women enrolling in antenatal clinic (ANC) at the site. All HIV+ pregnant women and a 1:1 systematic sample of HIV- pregnant women enrolling in ANC at the site will be prospectively enrolled. In addition, medical record data for the mother and infant will be collected at the time of delivery for all women who deliver at the site and as such will contribute to a subset of C2 (below). Women enrolled in C1 who do not deliver at the site will be contacted by phone and through field follow-up to ascertain their pregnancy and infant outcomes. Infants born to women enrolled in this component who are suspected of having congenital abnormalities (CAs) will be enrolled as outlined in C3 (below) if their mothers deliver at the site. If their mothers do not deliver at the site these infants will be enrolled in the field. Photos/videos of infants with CAs will also be taken for review and classification by a panel of experts (see C3 below).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (C2)</arm_group_label>
    <description>Cross-sectional data collection for deliveries at the site. Data will be collected retrospectively from medical records for all women who deliver at the site (including the women enrolled in C1 above), as well from the medical records of all newborn infants and stillbirths delivered at the site. Missing or incomplete information in the woman or her infant's medical record will be clarified by contacting the woman to provide this information.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 (C3)</arm_group_label>
    <description>Photos/videos of infants with CAs. All newborn infants and stillbirths ≥ 24 weeks gestational age delivered at the site, as well as all infants born to women enrolled in C1, will be assessed by surface exam for the presence of CAs. Video and photographs will be taken of CAs identified on surface exam. These images will be reviewed and classified by panel of experts in genetics, dysmorphology and teratology. Mothers of infants with major CAs will be contacted by phone at 1, 6, and 12 months post-delivery to ascertain their infants' vital status and care engagement status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacovigilance surveillance program</intervention_name>
    <description>The pharmacovigilance (PV) surveillance program will prospectively monitor for adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).</description>
    <arm_group_label>Cohort 1 (C1)</arm_group_label>
    <arm_group_label>Cohort 2 (C2)</arm_group_label>
    <arm_group_label>Cohort 3 (C3)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant and postpartum women who are HIV+ and HIV- and their infants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:&#xD;
&#xD;
        Inclusion criteria for women&#xD;
&#xD;
          1. Pregnant and enrolled in ANC at the study site;&#xD;
&#xD;
          2. Understands English or Swahili.&#xD;
&#xD;
        Exclusion criteria for women a. Any physical or mental disability that prevents the woman&#xD;
        from providing informed consent&#xD;
&#xD;
        Inclusion criteria for infants&#xD;
&#xD;
        a. All infants at any gestational age who are born to enrolled women will be included&#xD;
        Exclusion criteria for infants (none)&#xD;
&#xD;
        C2. Data collection for all deliveries at the site:&#xD;
&#xD;
        Inclusion criteria for women a. Woman delivers at the site and the delivery is registered&#xD;
        at the site&#xD;
&#xD;
        Exclusion criteria for women (none)&#xD;
&#xD;
        Inclusion criteria for live/stillborn infants&#xD;
&#xD;
        a. Infant is delivered at the site and results in the infant/stillbirth being registered at&#xD;
        the site&#xD;
&#xD;
        Exclusion criteria for infants (none)&#xD;
&#xD;
        C3. Photos/videos of infants with CAs:&#xD;
&#xD;
        Inclusion criteria for infants&#xD;
&#xD;
          1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age&#xD;
&#xD;
          2. The infant has a suspected CA on surface exam&#xD;
&#xD;
        Exclusion criteria for infants (none)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>John Humphrey, MD</last_name>
      <phone>317-274-8438</phone>
      <email>humphrjm@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Nichelle Turentine, BA</last_name>
      <phone>317-274-8114</phone>
      <email>nturenti@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>John Humphrey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rena Patel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edwin Were, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kara Wools-Kaloustian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mary-Ann Davies, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Boulle, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emma Kalk, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ushma Mehta, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Constantin Yiannoutsos, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Megan McHenry, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julia Songok, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bett Kipchumba, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wycliffe Kosgei, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marsha Alera, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caitlin Bernard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Beverly Musick, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Oyiengo, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elvis Oyugi, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Molly McPheron, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Carlucci, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Audrey Chepkemoi, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moi Teaching and Referral Hospital</name>
      <address>
        <city>Eldoret</city>
        <zip>30100</zip>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edwin O Were, MBChB, MMed</last_name>
      <phone>+254722288653</phone>
      <email>eowere@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Kara Wools-Kaloustian</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04405700
org study id: 2002126816
nct id: NCT04405700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to
      monitor adverse pregnancy and infant outcomes, including the presence of congenital
      abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites
      affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
In part 1 of this study, the investigators will use a mixed prospective and cross-sectional
      cohort study design to implement a PV program at two health facilities affiliated with the
      Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators
      will analyze these data to examine any associations between antiretroviral treatment (ART)
      and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create
      standardized protocols and data exchange standards within IeDEA to enable the merging and
      analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating
      Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and
      archiving data from the study in Kenya as well as data collected through a similar, ongoing
      study at health facilities in South Africa affiliated with IeDEA. This study will establish a
      multiregional PV infrastructure within IeDEA that can be further scaled within the broader
      IeDEA network.
observational model: Cohort
time perspective: Prospective
measure: Pregnancy outcomes
time frame: 2021-2022
description: Live Birth, Still Birth, Miscarriage, Termination of pregnancy, Ectopic Pregnancy, Molar Pregnancy, Not Pregnant, Other); also including pre-term delivery (<37 weeks gestational age) or very pre-term delivery (<32 weeks gestational age)
measure: Infant/birth outcomes
time frame: 2021-2022
description: Congenital abnormalities on newborn surface exam (e.g., extra digit, hydrocephalus, skull defects, eyes, face, mouth/lip/palate, chest, abdomen, anus, limbs, spine (including neural tube defects), hips, genitalia, skin, etc.); also including low birth weight, small for gestational age (<10th percentile) or very small for gestational age (<3rd percentile)
arm group label: Cohort 1 (C1)
description: Prospective recruitment of pregnant women enrolling in antenatal clinic (ANC) at the site. All HIV+ pregnant women and a 1:1 systematic sample of HIV- pregnant women enrolling in ANC at the site will be prospectively enrolled. In addition, medical record data for the mother and infant will be collected at the time of delivery for all women who deliver at the site and as such will contribute to a subset of C2 (below). Women enrolled in C1 who do not deliver at the site will be contacted by phone and through field follow-up to ascertain their pregnancy and infant outcomes. Infants born to women enrolled in this component who are suspected of having congenital abnormalities (CAs) will be enrolled as outlined in C3 (below) if their mothers deliver at the site. If their mothers do not deliver at the site these infants will be enrolled in the field. Photos/videos of infants with CAs will also be taken for review and classification by a panel of experts (see C3 below).
arm group label: Cohort 2 (C2)
description: Cross-sectional data collection for deliveries at the site. Data will be collected retrospectively from medical records for all women who deliver at the site (including the women enrolled in C1 above), as well from the medical records of all newborn infants and stillbirths delivered at the site. Missing or incomplete information in the woman or her infant's medical record will be clarified by contacting the woman to provide this information.
arm group label: Cohort 3 (C3)
description: Photos/videos of infants with CAs. All newborn infants and stillbirths ≥ 24 weeks gestational age delivered at the site, as well as all infants born to women enrolled in C1, will be assessed by surface exam for the presence of CAs. Video and photographs will be taken of CAs identified on surface exam. These images will be reviewed and classified by panel of experts in genetics, dysmorphology and teratology. Mothers of infants with major CAs will be contacted by phone at 1, 6, and 12 months post-delivery to ascertain their infants' vital status and care engagement status.
intervention type: Other
intervention name: Pharmacovigilance surveillance program
description: The pharmacovigilance (PV) surveillance program will prospectively monitor for adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
arm group label: Cohort 1 (C1)
arm group label: Cohort 2 (C2)
arm group label: Cohort 3 (C3)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Not yet recruiting
contact: 
contact backup: 
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facility: 
status: Recruiting
contact: 
country: Kenya
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Kara Wools-Kaloustian
investigator title: Professor of Medicine
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No