<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/NCT03005600</url>
  </required_header>
  <id_info>
    <org_study_id>MRMV0135</org_study_id>
    <nct_id>NCT03005600</nct_id>
  </id_info>
  <brief_title>Stratification of Risk of Diabetes in Early Pregnancy</brief_title>
  <acronym>STRiDE</acronym>
  <official_title>Stratification of Risk of Diabetes in Early Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Madras Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moi Univeristy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Warwick</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common&#xD;
      obstetric medical conditions which when undetected can cause significant adverse outcomes for&#xD;
      the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy&#xD;
      using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened&#xD;
      prior to detection. Although universal screening is recommended by many guidelines, this is&#xD;
      not uniformly followed across the world, partly because of doubts about cost-effectiveness.&#xD;
      Only selective screening is followed based on presence of at least one of the high risk&#xD;
      factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In&#xD;
      addition, no data exists in India and Kenya. In low and middle-income countries (LMICs),&#xD;
      where majority live in rural settings, the major limitations are difficulty in conducting&#xD;
      OGTT, which requires prompt access to laboratory facilities. Combining the clinical and&#xD;
      easily analysable biochemical markers (composite risk score) could improve the prediction and&#xD;
      if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes&#xD;
      levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better&#xD;
      marker as it can be done point-of-care and does not require patients to be in a fasting&#xD;
      state. The overall objective of the proposed project is to develop a composite risk score to&#xD;
      predict GDM in early pregnancy using a combination of easily identifiable risk factors such&#xD;
      as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The&#xD;
      project will recruit pregnant women in early pregnancy from South India (n=3400) and Western&#xD;
      Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score&#xD;
      on the risk of developing GDM will be assessed. Detailed health economic analyses will enable&#xD;
      policy makers to make informed decision based on local data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High glucose level in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most&#xD;
      common medical conditions during pregnancy. When undetected, it can cause significant harm&#xD;
      for the pregnant women and her offspring. GDM can affect 5-25% of all pregnant women. It&#xD;
      depends on the population and where the boundary is drawn between normal and abnormal glucose&#xD;
      levels.&#xD;
&#xD;
      Certain ethnic minority groups are considered at high-risk for developing GDM, including&#xD;
      Indians. It is estimated &gt;15% of pregnancies are affected by GDM in India. The immediate&#xD;
      risks of untreated GDM are high rates of pre-eclampsia, higher caesarean section rates and&#xD;
      psychological effects such as anxiety and depression. Women who develop GDM have a 7-8 times&#xD;
      higher life-time risk of type 2 diabetes (T2D). Similarly, the immediate risks to the&#xD;
      children are being too big or too small, shoulder damage during labour, low glucose levels or&#xD;
      jaundice at birth, difficulty in breathing and in rare cases stillbirth. In the long term,&#xD;
      the risk of obesity and T2D is also higher.&#xD;
&#xD;
      The diagnosis of GDM is usually made between 24-28 weeks of pregnancy using a glucose drink&#xD;
      test called oral glucose tolerance test (OGTT). Although treatment can improve the outcomes,&#xD;
      some of the damage may have already been done before the detection of GDM. Therefore,&#xD;
      screening to detect high glucose level in pregnancy seems beneficial. However, there can be&#xD;
      harms as well as benefits in screening programmes. Therefore a balance should be achieved&#xD;
      between identifying women whose blood glucose level is high enough to cause harm and those&#xD;
      with glucose level that would not cause harm. Currently, it is recommended that all pregnant&#xD;
      women should be screened for GDM if they belong to a high-risk ethnic population. However,&#xD;
      conducting OGTT in India is challenging, as this test requires pregnant women present&#xD;
      themselves to a laboratory facility in a fasting state.&#xD;
&#xD;
      In many countries, women are selected for OGTT based on the presence of at least one of the&#xD;
      high risk factors such as higher body weight, older age and family history of T2D. However,&#xD;
      this selection method can miss up to 50% of women who may develop GDM. The aim of the study&#xD;
      is to develop a risk score in early pregnancy based on a combination of these risk factors&#xD;
      that can be collected easily along with a simple finger prick average blood glucose test&#xD;
      (called HbA1c). The efficiency of different levels of this combined risk score will be tested&#xD;
      against the risk of developing GDM in the later part of pregnancy.&#xD;
&#xD;
      Cost effectiveness analysis will also be conducted to identify at what risk level screening&#xD;
      can be recommended in India. An accurate score that can safely exclude women at low risk of&#xD;
      developing GDM will have significant benefits to the pregnant women. They can be safely&#xD;
      reassured. Avoiding the need for OGTT will have significant time and cost benefits. In&#xD;
      contrast, if the score identifies them as at high-risk, healthy eating and appropriate life&#xD;
      style advice can reduce their risk of developing GDM in later pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>Development and validation of composite risk score for GDM with the risk factors of interest and/or point-of-care HbA1c</measure>
    <time_frame>3 YEARS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification and the impact of other novel risk factors on the diagnosis of GDM and other adverse maternal outcomes</measure>
    <time_frame>3 YEARS</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">7400</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Asian Indian</arm_group_label>
    <description>Recruitment to the Indian cohort will be carried out in urban areas of Chennai and be coordinated from Madras Diabetes Research Foundation (MDRF).&#xD;
As a part of their routine care, all pregnant women will undergo regular blood tests at presentation, a dating scan if the last menstrual period is unknown and an ultrasound at 20 weeks of pregnancy for foetal anomalies.&#xD;
3400 pregnant women in early pregnancy will be studied in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African</arm_group_label>
    <description>Recruitment to the Kenyan cohort will be based and coordinated from Moi Teaching and Referral hospital (MTRH). The bulk of the recruitment will happen at MTRH with significant contribution from Usain Gisu District hospital (UGDH) and Medi-Heal.&#xD;
4000 pregnant women in early pregnancy will be studied in this cohort.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Both sites have the capacity for all the necessary measurements. All samples will be&#xD;
      temporarily stored in fridge and -20°C freezers after which it will be shifted to -80°C&#xD;
      freezers for long term storage.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The project will be set in and around Chennai (Tamil Nadu, South India) and Eldoret&#xD;
        (Western Kenya). Two independent cohorts will be formed, comprising of 3400 and 4000&#xD;
        pregnant women in early pregnancy in India and Kenya, respectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pregnant women between the age of 18 and 50 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women presenting beyond 16 weeks of gestation Known Type 1 or Type 2 diabetes&#xD;
&#xD;
          -  Severe anaemia defined as haemoglobin (Hb) &lt;8g/L and&#xD;
&#xD;
          -  Sickle cell traits, sickle cell anaemia and other genetic Hb variants&#xD;
&#xD;
          -  Women on Metformin therapy for anovulation and/or infertility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ponnusamy Saravanan, FRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Warwick</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ponnusamy Saravanan, FRCP PhD</last_name>
    <phone>00442476 153592</phone>
    <email>P.Saravanan@warwick.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Deepa Mohan, PhD</last_name>
    <phone>00914443968888</phone>
    <email>deepa.mohan1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Madras Diabetes Research Foundation</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600086</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deepa Mohan, PhD</last_name>
      <phone>00914443968888</phone>
      <email>deepa.mohan1@gamil.com</email>
    </contact>
    <contact_backup>
      <last_name>Bhavadharini Balaji, PhD</last_name>
      <phone>00914443968888</phone>
      <email>bhavadharini.balaji@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>V Mohan, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Uma Ram, FRCOG</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ranjit M Anjana, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Deepa Mohan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moi University School of Medicine &amp; Teaching and Referral Hospital</name>
      <address>
        <city>Eldoret</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonak Pastakia, DPharm MPH</last_name>
      <phone>00254729027569</phone>
      <email>spastaki@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Wycliffe Kosgei, MBBS, MMed</last_name>
      <phone>00254723758638</phone>
      <email>wycliffe.kosgei@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sonak Pastakia, DPharm MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Astrid Christoffersen-Deb, MRCOG PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wycliffe Kosgei, MBBS, MMed</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Beryl Onyango, BPharm</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
    <country>Kenya</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Warwick</investigator_affiliation>
    <investigator_full_name>Dr P Saravanan</investigator_full_name>
    <investigator_title>Associate Clinical Professor &amp; Honorary Consultant Physician</investigator_title>
  </responsible_party>
  <keyword>Screening, diagnosis, risk stratification, ethnic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Metadata will be archived following the publication of the study findings as per MRC UK's guidelines</ipd_description>
  </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/NCT03005600
org study id: MRMV0135
nct id: NCT03005600
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common
      obstetric medical conditions which when undetected can cause significant adverse outcomes for
      the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy
      using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened
      prior to detection. Although universal screening is recommended by many guidelines, this is
      not uniformly followed across the world, partly because of doubts about cost-effectiveness.
      Only selective screening is followed based on presence of at least one of the high risk
      factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In
      addition, no data exists in India and Kenya. In low and middle-income countries (LMICs),
      where majority live in rural settings, the major limitations are difficulty in conducting
      OGTT, which requires prompt access to laboratory facilities. Combining the clinical and
      easily analysable biochemical markers (composite risk score) could improve the prediction and
      if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes
      levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better
      marker as it can be done point-of-care and does not require patients to be in a fasting
      state. The overall objective of the proposed project is to develop a composite risk score to
      predict GDM in early pregnancy using a combination of easily identifiable risk factors such
      as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The
      project will recruit pregnant women in early pregnancy from South India (n=3400) and Western
      Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score
      on the risk of developing GDM will be assessed. Detailed health economic analyses will enable
      policy makers to make informed decision based on local data.
High glucose level in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most
      common medical conditions during pregnancy. When undetected, it can cause significant harm
      for the pregnant women and her offspring. GDM can affect 5-25% of all pregnant women. It
      depends on the population and where the boundary is drawn between normal and abnormal glucose
      levels.

      Certain ethnic minority groups are considered at high-risk for developing GDM, including
      Indians. It is estimated >15% of pregnancies are affected by GDM in India. The immediate
      risks of untreated GDM are high rates of pre-eclampsia, higher caesarean section rates and
      psychological effects such as anxiety and depression. Women who develop GDM have a 7-8 times
      higher life-time risk of type 2 diabetes (T2D). Similarly, the immediate risks to the
      children are being too big or too small, shoulder damage during labour, low glucose levels or
      jaundice at birth, difficulty in breathing and in rare cases stillbirth. In the long term,
      the risk of obesity and T2D is also higher.

      The diagnosis of GDM is usually made between 24-28 weeks of pregnancy using a glucose drink
      test called oral glucose tolerance test (OGTT). Although treatment can improve the outcomes,
      some of the damage may have already been done before the detection of GDM. Therefore,
      screening to detect high glucose level in pregnancy seems beneficial. However, there can be
      harms as well as benefits in screening programmes. Therefore a balance should be achieved
      between identifying women whose blood glucose level is high enough to cause harm and those
      with glucose level that would not cause harm. Currently, it is recommended that all pregnant
      women should be screened for GDM if they belong to a high-risk ethnic population. However,
      conducting OGTT in India is challenging, as this test requires pregnant women present
      themselves to a laboratory facility in a fasting state.

      In many countries, women are selected for OGTT based on the presence of at least one of the
      high risk factors such as higher body weight, older age and family history of T2D. However,
      this selection method can miss up to 50% of women who may develop GDM. The aim of the study
      is to develop a risk score in early pregnancy based on a combination of these risk factors
      that can be collected easily along with a simple finger prick average blood glucose test
      (called HbA1c). The efficiency of different levels of this combined risk score will be tested
      against the risk of developing GDM in the later part of pregnancy.

      Cost effectiveness analysis will also be conducted to identify at what risk level screening
      can be recommended in India. An accurate score that can safely exclude women at low risk of
      developing GDM will have significant benefits to the pregnant women. They can be safely
      reassured. Avoiding the need for OGTT will have significant time and cost benefits. In
      contrast, if the score identifies them as at high-risk, healthy eating and appropriate life
      style advice can reduce their risk of developing GDM in later pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Development and validation of composite risk score for GDM with the risk factors of interest and/or point-of-care HbA1c
time frame: 3 YEARS
measure: Identification and the impact of other novel risk factors on the diagnosis of GDM and other adverse maternal outcomes
time frame: 3 YEARS
arm group label: Asian Indian
description: Recruitment to the Indian cohort will be carried out in urban areas of Chennai and be coordinated from Madras Diabetes Research Foundation (MDRF).
As a part of their routine care, all pregnant women will undergo regular blood tests at presentation, a dating scan if the last menstrual period is unknown and an ultrasound at 20 weeks of pregnancy for foetal anomalies.
3400 pregnant women in early pregnancy will be studied in this cohort.
arm group label: African
description: Recruitment to the Kenyan cohort will be based and coordinated from Moi Teaching and Referral hospital (MTRH). The bulk of the recruitment will happen at MTRH with significant contribution from Usain Gisu District hospital (UGDH) and Medi-Heal.
4000 pregnant women in early pregnancy will be studied in this cohort.
Both sites have the capacity for all the necessary measurements. All samples will be
      temporarily stored in fridge and -20°C freezers after which it will be shifted to -80°C
      freezers for long term storage.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ponnusamy Saravanan, FRCP PhD
role: Principal Investigator
affiliation: University of Warwick
last name: Ponnusamy Saravanan, FRCP PhD
phone: 00442476 153592
email: P.Saravanan@warwick.ac.uk
last name: Deepa Mohan, PhD
phone: 00914443968888
email: deepa.mohan1@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: India
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Warwick
investigator full name: Dr P Saravanan
investigator title: Associate Clinical Professor & Honorary Consultant Physician
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: Yes
ipd description: Metadata will be archived following the publication of the study findings as per MRC UK's guidelines