<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/NCT02989220</url>
  </required_header>
  <id_info>
    <org_study_id>RHM O&amp;G0207</org_study_id>
    <nct_id>NCT02989220</nct_id>
  </id_info>
  <brief_title>Feasibility Study of a Coping Intervention for Recurrent Miscarriage</brief_title>
  <official_title>A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some women experience the pain of miscarriage on numerous occasions. Studies show that these&#xD;
      women experience feelings of anxiety and distress during the early stages of a new pregnancy&#xD;
      as they worry another miscarriage will occur. This study will investigate whether a coping&#xD;
      strategy, developed for a similar group of women, would be acceptable and useful to women&#xD;
      suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A&#xD;
      secondary aim of the study is to develop a deeper understanding of the experiences and&#xD;
      feelings of women in the early stages of a new pregnancy, following multiple miscarriages.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2014</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients recruited into the study using current inclusion/exclusion criteria</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of completed questionnaires</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Are the proposed study questionnaires and data collection methods appropriate?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data collected from questionnaires</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Is there a preliminary indication of an effect of the PRCI?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Data Collected from questionnaires</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Data Collected from questionnaires</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Data Collected from questionnaires</measure>
    <time_frame>Through Study Completion - Average of 1 year</time_frame>
    <description>Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Miscarriage</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive the PRCI in addition to the current recommended care pathway</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will follow the current recommended care pathway</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positive Reappraisal Coping Intervention</intervention_name>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with three or more miscarriages&#xD;
&#xD;
          -  Women aged &gt;18 years&#xD;
&#xD;
          -  Willing and able to give written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women will be excluded from this study if they do not speak English well enough to&#xD;
             understand and complete study materials. This criterion is in place because the study&#xD;
             materials (including PRCI) are not currently available in translation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Princess Anne Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 8YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Miscarriage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Habitual</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/NCT02989220
org study id: RHM O&G0207
nct id: NCT02989220
lead sponsor: 
has dmc: No
Some women experience the pain of miscarriage on numerous occasions. Studies show that these
      women experience feelings of anxiety and distress during the early stages of a new pregnancy
      as they worry another miscarriage will occur. This study will investigate whether a coping
      strategy, developed for a similar group of women, would be acceptable and useful to women
      suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A
      secondary aim of the study is to develop a deeper understanding of the experiences and
      feelings of women in the early stages of a new pregnancy, following multiple miscarriages.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
time frame: Through Study Completion - Average of 1 year
description: How acceptable are the proposed methods of recruitment, randomisation, intervention and follow-up?
measure: Number of patients recruited into the study using current inclusion/exclusion criteria
time frame: Through Study Completion - Average of 1 year
description: Is it possible to achieve acceptable recruitment and retention rates within each centre, taking into account defined inclusion/exclusion criteria?
measure: Number of completed questionnaires
time frame: Through Study Completion - Average of 1 year
description: Are the proposed study questionnaires and data collection methods appropriate?
measure: Data collected from questionnaires
time frame: Through Study Completion - Average of 1 year
description: Is there a preliminary indication of an effect of the PRCI?
measure: Data Collected from questionnaires
time frame: Through Study Completion - Average of 1 year
description: Qualitative analysis of questionnaires to explore in-depth women's subjective experience of the study intervention and research methods (including study outcome measures).
measure: Data Collected from questionnaires
time frame: Through Study Completion - Average of 1 year
description: Qualitative analysis of questionnaires to provide information to refine the study intervention (if required).
measure: Data Collected from questionnaires
time frame: Through Study Completion - Average of 1 year
description: Qualitative analysis of questionnaires to strengthen further in-depth understanding of the initial experience of pregnancy following repeated miscarriages.
arm group label: Intervention group
arm group type: Experimental
description: Will receive the PRCI in addition to the current recommended care pathway
arm group label: Control Group
arm group type: No Intervention
description: Will follow the current recommended care pathway
intervention type: Other
intervention name: Positive Reappraisal Coping Intervention
arm group label: Intervention group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Abortion, Spontaneous
mesh term: Abortion, Habitual