xml: <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/NCT06005272</url>
    </required_header>
    <id_info>
      <org_study_id>314658</org_study_id>
      <nct_id>NCT06005272</nct_id>
    </id_info>
    <brief_title>Mothers Working to Prevent Early Stillbirth Study 20-28</brief_title>
    <acronym>MiNESS20-28</acronym>
    <official_title>Mothers Working to Prevent Early Stillbirth Study 20-28</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manchester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Birmingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Manchester</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>
        This project aims to identify factors linked to pregnancy losses occurring between 20 and 28&#xD;
        weeks of pregnancy that can be modified by changing mother's behaviour or healthcare&#xD;
        provision.&#xD;
  &#xD;
        The death of a child before birth (also called stillbirth or miscarriage) has enduring&#xD;
        psychological, social and economic effects for women, their families and wider society. In&#xD;
        2015, the stillbirth rate in the UK was higher than comparable countries. The UK government&#xD;
        has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of&#xD;
        pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks&#xD;
        of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year.&#xD;
  &#xD;
        Identification of modifiable causes of stillbirth was identified as a research priority by&#xD;
        the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third&#xD;
        of whom were bereaved parents. The investigators previously completed a study of 291 women&#xD;
        who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in&#xD;
        41 maternity units in the UK. This study identified factors linked to stillbirth which can be&#xD;
        changed including the position women go to sleep in, cigarette smoking and caffeine&#xD;
        consumption. In addition, the investigators previously found changes in mother's perception&#xD;
        of baby's movements, whether women had tests for diabetes or whether women were exposed to&#xD;
        domestic violence or stressful situations. These factors can be addressed by different care&#xD;
        in pregnancy. Information from this study has been included in national and international&#xD;
        guidelines that aim to reduce stillbirth.&#xD;
  &#xD;
        The investigators will use the same study type to identify factors associated with pregnancy&#xD;
        loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked&#xD;
        parents who have experienced the death of a baby at these stages of pregnancy about the&#xD;
        design of the study, the questions that would be asked and how best to approach bereaved&#xD;
        parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not&#xD;
        usually &quot;counted&quot; in UK stillbirth statistics. The investigators will need 316 women with&#xD;
        stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy&#xD;
        to participate in the study. All women will complete a questionnaire about themselves, their&#xD;
        diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will&#xD;
        compare information between women who have early stillbirth and those who have a live birth&#xD;
        to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study&#xD;
        findings will be disseminated in collaboration with patient organisations using effective&#xD;
        ways to reach pregnant women. The investigators anticipate the findings from this study will&#xD;
        be included in clinical practice guidelines and rapidly translated into antenatal care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research question What are the modifiable risk factors for early stillbirth (between 20-28&#xD;
        weeks' gestation)?&#xD;
  &#xD;
        Background The NHS Long Term Plan sets a goal to reduce stillbirth by 50% by 2025 (from 2013&#xD;
        rates). Some progress has been made with reduction of stillbirths in late pregnancy (≥28&#xD;
        weeks' gestation). However, rates of early stillbirth (&lt;28 weeks' gestation) remain&#xD;
        intractable and new initiatives to reduce early stillbirth rates are needed to achieve this&#xD;
        goal. Our previous study (MiNESS) informed about modifiable risk factors for stillbirth ≥28&#xD;
        weeks' gestation and were incorporated into national guidance to reduce stillbirth. However,&#xD;
        there is an evidence gap related to modifiable risk factors for early stillbirth.&#xD;
  &#xD;
        Aims and Objectives The overall aim of the study is to&#xD;
  &#xD;
          1. Identify modifiable risk factors for early stillbirth that are amenable to public health&#xD;
             campaigns or adaptation of antenatal care.&#xD;
  &#xD;
             The study will specifically,&#xD;
  &#xD;
          2. Confirm or refute whether modifiable behavioural factors associated with late stillbirth&#xD;
             are also independently associated with early stillbirth.&#xD;
  &#xD;
          3. Explore interactions between maternal characteristics (especially those relating to&#xD;
             health inequalities including ethnicity and socioeconomic deprivation), fetal factors&#xD;
             (including fetal growth restriction, reduced fetal movements) and early stillbirth risk.&#xD;
  &#xD;
          4. Determine differences in risk factor profiles by cause of death.&#xD;
  &#xD;
        Methods This study uses a case-control design based upon that successfully used in the MiNESS&#xD;
        study. The eligible population are women with a non-anomalous singleton pregnancy. &quot;Cases&quot;&#xD;
        are women who have a stillbirth between 20+0 and 27+6 weeks' gestation and &quot;Controls&quot; are&#xD;
        women who have an ongoing viable pregnancy at an equivalent gestational age. Controls will be&#xD;
        randomly selected from participating maternity units' booking list at the appropriate week of&#xD;
        pregnancy to match the unit's historic distribution of early stillbirths in a 1:2&#xD;
        (case:control) ratio. The study will recruit 316 cases and 632 controls; this gives 80% power&#xD;
        to detect associations with an odds ratio ≥1.5. Participants will complete a&#xD;
        researcher-administered questionnaire and relevant data will be extracted from medical&#xD;
        records. Cases will be approached before hospital discharge, aiming to complete the research&#xD;
        interview where possible within 3 weeks.&#xD;
  &#xD;
        Unadjusted associations between early stillbirth and each exposure will be calculated.&#xD;
        Logistic regression models, adjusted for confounding variables, will consider multiple&#xD;
        exposures in relation to early stillbirth.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Maternal sleep position during pregnancy</measure>
      <time_frame>The night prior to questionnaire or the night prior to pregnancy loss</time_frame>
      <description>Self-reported sleep position</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of sleep during pregnancy</measure>
      <time_frame>The night prior to questionnaire or the night prior to pregnancy loss</time_frame>
      <description>Self-reported duration of sleep</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Presence of snoring during pregnancy</measure>
      <time_frame>The night prior to questionnaire or the night prior to pregnancy loss</time_frame>
      <description>Self-reported presence of snoring during pregnancy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maternal perception of fetal movement frequency</measure>
      <time_frame>Two-weeks prior to questionnaire or two weeks prior to pregnancy loss</time_frame>
      <description>Self-reported perception of frequency of fetal activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal perception of fetal movement strength</measure>
      <time_frame>Two-weeks prior to questionnaire or two weeks prior to pregnancy loss</time_frame>
      <description>Self-reported perception of strength of fetal activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal caffeine exposure</measure>
      <time_frame>One month prior to questionnaire</time_frame>
      <description>Self-reported intake of caffeinated drinks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Engagement with antenatal care</measure>
      <time_frame>Duration of Pregnancy (from booking to the time interview)</time_frame>
      <description>Number of appointments with health professionals</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to Intimate Partner Violence</measure>
      <time_frame>Duration of Pregnancy (from booking to the time interview)</time_frame>
      <description>Self-reported exposure to abusive behaviour using standardised questions</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">948</enrollment>
    <condition>Stillbirth and Fetal Death</condition>
    <condition>Perinatal Death</condition>
    <arm_group>
      <arm_group_label>Cases</arm_group_label>
      <description>Recently pregnant women/people who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>Individuals still pregnant at same gestational age</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>Interviewer assisted completion of questionnaire.</description>
      <arm_group_label>Cases</arm_group_label>
      <arm_group_label>Controls</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women who have experienced an early stillbirth and women who have an ongoing pregnancy at&#xD;
          gestations matched to the profile of women who experienced an early stillbirth from&#xD;
          participating maternity units in the UK.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Cases&#xD;
  &#xD;
            -  Bereaved mothers/parents who have recently birthed a singleton baby who died&#xD;
               before/during or immediately after labour between 20 and 28 weeks of pregnancy.&#xD;
  &#xD;
            -  Baby has no evidence of congenital anomaly&#xD;
  &#xD;
            -  Able to give written informed consent&#xD;
  &#xD;
          Controls&#xD;
  &#xD;
            -  Pregnant women/people with an ongoing pregnancy (at the target gestation) receiving&#xD;
               antenatal care from a participating maternity unit, at a gestation matched to the&#xD;
               distribution of stillbirths between 20 to 28 weeks of pregnancy in the same unit&#xD;
  &#xD;
            -  Baby has no evidence of congenital anomaly&#xD;
  &#xD;
            -  Able to give written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alexander E Heazell, PhD</last_name>
      <phone>+441612646484</phone>
      <email>alexander.heazell@manchester.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lucy Higgins, PhD</last_name>
      <email>lucy.higgins@manchester.ac.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manchester</investigator_affiliation>
      <investigator_full_name>Dr Alexander Heazell</investigator_full_name>
      <investigator_title>Professor of Obstetrics</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stillbirth</mesh_term>
      <mesh_term>Fetal Death</mesh_term>
      <mesh_term>Perinatal Death</mesh_term>
      <mesh_term>Death</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Awaiting clearance from the Health Research Authority to share anonymised data for IPD.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005272
  org study id: 314658
  nct id: NCT06005272
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project aims to identify factors linked to pregnancy losses occurring between 20 and 28
        weeks of pregnancy that can be modified by changing mother's behaviour or healthcare
        provision.
  
        The death of a child before birth (also called stillbirth or miscarriage) has enduring
        psychological, social and economic effects for women, their families and wider society. In
        2015, the stillbirth rate in the UK was higher than comparable countries. The UK government
        has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of
        pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks
        of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year.
  
        Identification of modifiable causes of stillbirth was identified as a research priority by
        the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third
        of whom were bereaved parents. The investigators previously completed a study of 291 women
        who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in
        41 maternity units in the UK. This study identified factors linked to stillbirth which can be
        changed including the position women go to sleep in, cigarette smoking and caffeine
        consumption. In addition, the investigators previously found changes in mother's perception
        of baby's movements, whether women had tests for diabetes or whether women were exposed to
        domestic violence or stressful situations. These factors can be addressed by different care
        in pregnancy. Information from this study has been included in national and international
        guidelines that aim to reduce stillbirth.
  
        The investigators will use the same study type to identify factors associated with pregnancy
        loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked
        parents who have experienced the death of a baby at these stages of pregnancy about the
        design of the study, the questions that would be asked and how best to approach bereaved
        parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not
        usually "counted" in UK stillbirth statistics. The investigators will need 316 women with
        stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy
        to participate in the study. All women will complete a questionnaire about themselves, their
        diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will
        compare information between women who have early stillbirth and those who have a live birth
        to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study
        findings will be disseminated in collaboration with patient organisations using effective
        ways to reach pregnant women. The investigators anticipate the findings from this study will
        be included in clinical practice guidelines and rapidly translated into antenatal care.
  Research question What are the modifiable risk factors for early stillbirth (between 20-28
        weeks' gestation)?
  
        Background The NHS Long Term Plan sets a goal to reduce stillbirth by 50% by 2025 (from 2013
        rates). Some progress has been made with reduction of stillbirths in late pregnancy (≥28
        weeks' gestation). However, rates of early stillbirth (<28 weeks' gestation) remain
        intractable and new initiatives to reduce early stillbirth rates are needed to achieve this
        goal. Our previous study (MiNESS) informed about modifiable risk factors for stillbirth ≥28
        weeks' gestation and were incorporated into national guidance to reduce stillbirth. However,
        there is an evidence gap related to modifiable risk factors for early stillbirth.
  
        Aims and Objectives The overall aim of the study is to
  
          1. Identify modifiable risk factors for early stillbirth that are amenable to public health
             campaigns or adaptation of antenatal care.
  
             The study will specifically,
  
          2. Confirm or refute whether modifiable behavioural factors associated with late stillbirth
             are also independently associated with early stillbirth.
  
          3. Explore interactions between maternal characteristics (especially those relating to
             health inequalities including ethnicity and socioeconomic deprivation), fetal factors
             (including fetal growth restriction, reduced fetal movements) and early stillbirth risk.
  
          4. Determine differences in risk factor profiles by cause of death.
  
        Methods This study uses a case-control design based upon that successfully used in the MiNESS
        study. The eligible population are women with a non-anomalous singleton pregnancy. "Cases"
        are women who have a stillbirth between 20+0 and 27+6 weeks' gestation and "Controls" are
        women who have an ongoing viable pregnancy at an equivalent gestational age. Controls will be
        randomly selected from participating maternity units' booking list at the appropriate week of
        pregnancy to match the unit's historic distribution of early stillbirths in a 1:2
        (case:control) ratio. The study will recruit 316 cases and 632 controls; this gives 80% power
        to detect associations with an odds ratio ≥1.5. Participants will complete a
        researcher-administered questionnaire and relevant data will be extracted from medical
        records. Cases will be approached before hospital discharge, aiming to complete the research
        interview where possible within 3 weeks.
  
        Unadjusted associations between early stillbirth and each exposure will be calculated.
        Logistic regression models, adjusted for confounding variables, will consider multiple
        exposures in relation to early stillbirth.
  observational model: Case-Control
  time perspective: Prospective
  measure: Maternal sleep position during pregnancy
  time frame: The night prior to questionnaire or the night prior to pregnancy loss
  description: Self-reported sleep position
  measure: Duration of sleep during pregnancy
  time frame: The night prior to questionnaire or the night prior to pregnancy loss
  description: Self-reported duration of sleep
  measure: Presence of snoring during pregnancy
  time frame: The night prior to questionnaire or the night prior to pregnancy loss
  description: Self-reported presence of snoring during pregnancy
  measure: Maternal perception of fetal movement frequency
  time frame: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
  description: Self-reported perception of frequency of fetal activity
  measure: Maternal perception of fetal movement strength
  time frame: Two-weeks prior to questionnaire or two weeks prior to pregnancy loss
  description: Self-reported perception of strength of fetal activity
  measure: Maternal caffeine exposure
  time frame: One month prior to questionnaire
  description: Self-reported intake of caffeinated drinks
  measure: Engagement with antenatal care
  time frame: Duration of Pregnancy (from booking to the time interview)
  description: Number of appointments with health professionals
  measure: Exposure to Intimate Partner Violence
  time frame: Duration of Pregnancy (from booking to the time interview)
  description: Self-reported exposure to abusive behaviour using standardised questions
  arm group label: Cases
  description: Recently pregnant women/people who have experienced baby loss during pregnancy, labour or shortly after birth between 20-28 weeks of pregnancy
  arm group label: Controls
  description: Individuals still pregnant at same gestational age
  intervention type: Other
  intervention name: Questionnaire
  description: Interviewer assisted completion of questionnaire.
  arm group label: Cases
  arm group label: Controls
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 16 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alexander E Heazell, PhD
  phone: +441612646484
  email: alexander.heazell@manchester.ac.uk
  last name: Lucy Higgins, PhD
  email: lucy.higgins@manchester.ac.uk
  responsible party type: Principal Investigator
  investigator affiliation: University of Manchester
  investigator full name: Dr Alexander Heazell
  investigator title: Professor of Obstetrics
  mesh term: Stillbirth
  mesh term: Fetal Death
  mesh term: Perinatal Death
  mesh term: Death
  sharing ipd: Undecided
  ipd description: Awaiting clearance from the Health Research Authority to share anonymised data for IPD.