<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/NCT04446949</url>
  </required_header>
  <id_info>
    <org_study_id>68329</org_study_id>
    <nct_id>NCT04446949</nct_id>
  </id_info>
  <brief_title>Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.</brief_title>
  <official_title>Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Women's Public Health Association (NKS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo Church City Mission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Red Cross</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Emergency General Practice (DEGP) Oslo and Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</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>
      Little research on the health service utilization and the health situation of undocumented&#xD;
      pregnant migrants has been performed previously, and it is essential to obtain more&#xD;
      information on the services given, and to examine whether residency status is a risk factor&#xD;
      in maternal and perinatal health among migrants.This project will give new knowledge on&#xD;
      undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in&#xD;
      Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The&#xD;
      project will present new knowledge by showing trends in undocumented pregnant migrants care&#xD;
      seeking compared to general trends among other migrants and Norwegian residents. It will also&#xD;
      give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants&#xD;
      compared to foreign and Norwegian born women. This approach has not previously been used to&#xD;
      study undocumented migrants in Norway, and there are very few similar studies in other&#xD;
      European countries. Cause and effect relations are rarely claimed in findings from&#xD;
      observational epidemiologic studies, however the information from three different sources&#xD;
      (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall&#xD;
      picture of the use of primary health care in undocumented pregnant migrants, as well as a&#xD;
      comparative assessment of maternal outcomes in this population. The proposed research will&#xD;
      also give important knowledge on how to conduct quantitative research in a population that is&#xD;
      difficult to reach, and that is not commonly included in research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research questions and objectives&#xD;
&#xD;
        1. Work package 1 (WP1): What characterizes pregnant undocumented migrants attending the&#xD;
           voluntary clinics in Oslo and Bergen from 2009 to 2020?&#xD;
&#xD;
             1. Give a descriptive summary of the population of pregnant undocumented migrants&#xD;
                seeking care (e.g. age, number of children, time stayed in Norway, work status,&#xD;
                family network) and the medical problems they are presenting.&#xD;
&#xD;
             2. Investigate the care received based on indicators such as number of antenatal&#xD;
                visits and the extent of collaboration with or referral to other health facilities.&#xD;
&#xD;
             3. Investigate the risk of pregnancy related complications (e.g. pre-eclampsia and&#xD;
                gestational diabetes) and adverse perinatal outcomes (e.g. use of Caesarean Section&#xD;
                and pre-term birth) in women seeking care at the clinics.&#xD;
&#xD;
        2. Work package 2 (WP2): Are there any consultation trends in pregnant undocumented&#xD;
           migrants seeking emergency care at the emergency units (DEGPs) in Oslo and Bergen from&#xD;
           2007 to 2020?&#xD;
&#xD;
             1. Give a descriptive summary of the population of undocumented migrants seeking&#xD;
                emergency care at the DEGPs, in particular pregnant undocumented migrants seeking&#xD;
                care.&#xD;
&#xD;
             2. Investigate trends in emergency consultations at the DEGPs for pregnant&#xD;
                undocumented migrants after the start of the voluntary clinics (2009/2014),&#xD;
                comparing with the trends in consultations for the general population of pregnant&#xD;
                women seeking care.&#xD;
&#xD;
             3. Investigate trends in emergency consultations at the DEGPs for pregnant&#xD;
                undocumented migrants after the start of the voluntary clinics (2009/2014),&#xD;
                comparing to the trends in consultations for other undocumented migrants.&#xD;
&#xD;
        3. Work package 3 (WP3): What is the occurrence of pregnancy-related complications and&#xD;
           adverse perinatal outcomes (as reported in the Medical Birth Registry of Norway) in&#xD;
           patients without national identity number from 1999 to 2020?&#xD;
&#xD;
             1. Investigate the prevalence of pregnancy related complications (e.g. pre-eclampsia,&#xD;
                gestational diabetes, nutrient deficiency) in undocumented migrant women compared&#xD;
                to foreign and Norwegian born women.&#xD;
&#xD;
             2. Investigate the incidence of adverse perinatal outcomes (e.g. use of Caesarean&#xD;
                section, pre-term birth, small for gestational age, low Apgar score) in&#xD;
                undocumented migrant women compared with foreign and Norwegian born women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Anticipated">February 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse pregnancy outcomes</measure>
    <time_frame>1999-2020</time_frame>
    <description>From medical records and the Medical Birth Registry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary health care use by undocumented pregnant migrants</measure>
    <time_frame>2007-2020</time_frame>
    <description>From voluntary clinics and emergency units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care use of undocumented migrants in general</measure>
    <time_frame>2007-2020</time_frame>
    <description>From voluntary clinics and emergency units</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">70000</enrollment>
  <condition>Transients and Migrants</condition>
  <condition>Primary Health Care</condition>
  <condition>Pregnancy Outcome</condition>
  <arm_group>
    <arm_group_label>Undocumented migrants</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Immigrants with Norwegian ID</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Norwegian residents</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Register follow-up</intervention_name>
    <description>Number of adverse pregnancy outcomes</description>
    <arm_group_label>Immigrants with Norwegian ID</arm_group_label>
    <arm_group_label>Norwegian residents</arm_group_label>
    <arm_group_label>Undocumented migrants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        WP1: Women attending voluntary clinics for primary care to undocumented migrants in Oslo&#xD;
        and Bergen WP2: Patients without a national ID receiving treatment at the emergency care&#xD;
        units in Oslo and Bergen WP3: Women registered to give birth in the Medical Birth Registry&#xD;
        of Norway (probably undocumented migrants without a Norwegian ID, Norwegian residents with&#xD;
        an immigration background, Norwegian-born women)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No registered Norwegian identity number&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women giving birth in Norway</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilie Dahl, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frode Eick, M.Phil</last_name>
    <phone>+4793853244</phone>
    <email>Frode.Eick@bymisjon.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cecilie Dahl, PhD, MPH</last_name>
    <phone>+4740550210</phone>
    <email>Cecilie.dahl@medisin.uio.no</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Cecilie Dahl</investigator_full_name>
    <investigator_title>Dr. Cecilie Dahl</investigator_title>
  </responsible_party>
  <keyword>Norway</keyword>
  <keyword>Emergency care</keyword>
  <keyword>Medical Birth Registry</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are not allowed to share IPD due to GDPR regulations and Norwegian Law.</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/NCT04446949
org study id: 68329
nct id: NCT04446949
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Little research on the health service utilization and the health situation of undocumented
      pregnant migrants has been performed previously, and it is essential to obtain more
      information on the services given, and to examine whether residency status is a risk factor
      in maternal and perinatal health among migrants.This project will give new knowledge on
      undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in
      Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The
      project will present new knowledge by showing trends in undocumented pregnant migrants care
      seeking compared to general trends among other migrants and Norwegian residents. It will also
      give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants
      compared to foreign and Norwegian born women. This approach has not previously been used to
      study undocumented migrants in Norway, and there are very few similar studies in other
      European countries. Cause and effect relations are rarely claimed in findings from
      observational epidemiologic studies, however the information from three different sources
      (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall
      picture of the use of primary health care in undocumented pregnant migrants, as well as a
      comparative assessment of maternal outcomes in this population. The proposed research will
      also give important knowledge on how to conduct quantitative research in a population that is
      difficult to reach, and that is not commonly included in research.
Research questions and objectives

        1. Work package 1 (WP1): What characterizes pregnant undocumented migrants attending the
           voluntary clinics in Oslo and Bergen from 2009 to 2020?

             1. Give a descriptive summary of the population of pregnant undocumented migrants
                seeking care (e.g. age, number of children, time stayed in Norway, work status,
                family network) and the medical problems they are presenting.

             2. Investigate the care received based on indicators such as number of antenatal
                visits and the extent of collaboration with or referral to other health facilities.

             3. Investigate the risk of pregnancy related complications (e.g. pre-eclampsia and
                gestational diabetes) and adverse perinatal outcomes (e.g. use of Caesarean Section
                and pre-term birth) in women seeking care at the clinics.

        2. Work package 2 (WP2): Are there any consultation trends in pregnant undocumented
           migrants seeking emergency care at the emergency units (DEGPs) in Oslo and Bergen from
           2007 to 2020?

             1. Give a descriptive summary of the population of undocumented migrants seeking
                emergency care at the DEGPs, in particular pregnant undocumented migrants seeking
                care.

             2. Investigate trends in emergency consultations at the DEGPs for pregnant
                undocumented migrants after the start of the voluntary clinics (2009/2014),
                comparing with the trends in consultations for the general population of pregnant
                women seeking care.

             3. Investigate trends in emergency consultations at the DEGPs for pregnant
                undocumented migrants after the start of the voluntary clinics (2009/2014),
                comparing to the trends in consultations for other undocumented migrants.

        3. Work package 3 (WP3): What is the occurrence of pregnancy-related complications and
           adverse perinatal outcomes (as reported in the Medical Birth Registry of Norway) in
           patients without national identity number from 1999 to 2020?

             1. Investigate the prevalence of pregnancy related complications (e.g. pre-eclampsia,
                gestational diabetes, nutrient deficiency) in undocumented migrant women compared
                to foreign and Norwegian born women.

             2. Investigate the incidence of adverse perinatal outcomes (e.g. use of Caesarean
                section, pre-term birth, small for gestational age, low Apgar score) in
                undocumented migrant women compared with foreign and Norwegian born women.
observational model: Cohort
time perspective: Other
measure: Adverse pregnancy outcomes
time frame: 1999-2020
description: From medical records and the Medical Birth Registry
measure: Primary health care use by undocumented pregnant migrants
time frame: 2007-2020
description: From voluntary clinics and emergency units
measure: Health care use of undocumented migrants in general
time frame: 2007-2020
description: From voluntary clinics and emergency units
arm group label: Undocumented migrants
arm group label: Immigrants with Norwegian ID
arm group label: Norwegian residents
intervention type: Other
intervention name: Register follow-up
description: Number of adverse pregnancy outcomes
arm group label: Immigrants with Norwegian ID
arm group label: Norwegian residents
arm group label: Undocumented migrants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women giving birth in Norway
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Cecilie Dahl, PhD, MPH
role: Principal Investigator
affiliation: University of Oslo
last name: Frode Eick, M.Phil
phone: +4793853244
email: Frode.Eick@bymisjon.no
last name: Cecilie Dahl, PhD, MPH
phone: +4740550210
email: Cecilie.dahl@medisin.uio.no
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Cecilie Dahl
investigator title: Dr. Cecilie Dahl
sharing ipd: No
ipd description: We are not allowed to share IPD due to GDPR regulations and Norwegian Law.