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/NCT06029673</url>
    </required_header>
    <id_info>
      <org_study_id>71540</org_study_id>
      <nct_id>NCT06029673</nct_id>
    </id_info>
    <brief_title>Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss</brief_title>
    <acronym>eLISTA</acronym>
    <official_title>Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Planned Parenthood Mar Monte</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Breast pain following second-trimester abortion is common. Breast engorgement and milk&#xD;
        leakage following second-trimester perinatal loss and abortion can cause both physical pain&#xD;
        and emotional distress. Dopamine agonists have previously been shown to be effective in&#xD;
        lactation inhibition for third-trimester fetal/neonatal loss or contraindications to&#xD;
        breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single&#xD;
        dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28&#xD;
        weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to&#xD;
        determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a double-blinded, placebo-controlled, gestational-age stratified superiority&#xD;
        trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks&#xD;
        gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg&#xD;
        or placebo the day of procedure. Participants will complete a survey to assess symptoms,&#xD;
        using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day&#xD;
        2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to&#xD;
        detect a 45% decrease in those reporting breast symptoms compared to the control group.&#xD;
  &#xD;
        This study has the potential to improve overall patient experience by validating the routine&#xD;
        use of cabergoline for lactation inhibition in the early second-trimester after abortion or&#xD;
        pregnancy loss.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 2</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>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Reporting Breast Pain</measure>
      <time_frame>Day 4 after procedure</time_frame>
      <description>Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Side-effects</measure>
      <time_frame>Cumulative over 2 weeks</time_frame>
      <description>Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Reporting Significant Bother From Breast Pain</measure>
      <time_frame>Day 4 after procedure</time_frame>
      <description>Assessed using a Facial Pain Score (scale range 0-6, significant bother &gt;=4)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Reporting Significant Bother From Side-effects</measure>
      <time_frame>Cumulative over 2 weeks</time_frame>
      <description>Assessed using a Facial Pain Score (scale range 0-6, significant bother &gt;=4)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Lactation Suppressed</condition>
    <arm_group>
      <arm_group_label>Cabergoline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cabergoline 1 MG</intervention_name>
      <description>Dopamine agonist</description>
      <arm_group_label>Cabergoline</arm_group_label>
      <other_name>Dosintex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant people, ages 18 years or older&#xD;
  &#xD;
            -  Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating&#xD;
               performed prior to or same day of enrollment visit)&#xD;
  &#xD;
            -  Consented for an induced, elective abortion or undergoing management of fetal demise&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Able to consent for a research study, literate in English or Spanish&#xD;
  &#xD;
            -  Willing to comply with study procedures and follow-up&#xD;
  &#xD;
            -  Access to smart phone throughout study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          18 Years Female No No&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant people, ages 18 years or older&#xD;
  &#xD;
            -  Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating&#xD;
               performed prior to or same day of enrollment visit)&#xD;
  &#xD;
            -  Consented for an induced, elective abortion or undergoing induction for demise&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Able to consent for a research study, literate in English or Spanish&#xD;
  &#xD;
            -  Willing to comply with study procedures and follow-up&#xD;
  &#xD;
            -  Access to smart phone throughout study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior mastectomy (breast reduction or chest masculinization surgery acceptable)&#xD;
  &#xD;
            -  Currently breastfeeding&#xD;
  &#xD;
            -  Currently receiving dopamine agonist or antagonist therapy for other indication leg&#xD;
               syndrome)&#xD;
  &#xD;
            -  Contraindication to cabergoline (as per package insert)&#xD;
  &#xD;
            -  Uncontrolled hypertension - defined as baseline BP &gt; 160/110, or chronic hypertension&#xD;
               requiring more than one baseline medication, or current pregnancy-induced hypertension&#xD;
               spectrum disorders (gestational hypertension, preeclampsia, eclampsia)&#xD;
  &#xD;
            -  History of cardiac valvular disorders or valvular repair&#xD;
  &#xD;
            -  History of pulmonary, pericardial, or retroperitoneal fibrotic disorders&#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>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>abortion</keyword>
    <keyword>fetal demise</keyword>
    <keyword>lactation</keyword>
    <keyword>engorgement</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cabergoline</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data may be requested for meta-analysis inclusion</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT06029673
  org study id: 71540
  nct id: NCT06029673
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Breast pain following second-trimester abortion is common. Breast engorgement and milk
        leakage following second-trimester perinatal loss and abortion can cause both physical pain
        and emotional distress. Dopamine agonists have previously been shown to be effective in
        lactation inhibition for third-trimester fetal/neonatal loss or contraindications to
        breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single
        dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28
        weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to
        determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
  This study is a double-blinded, placebo-controlled, gestational-age stratified superiority
        trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks
        gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg
        or placebo the day of procedure. Participants will complete a survey to assess symptoms,
        using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day
        2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to
        detect a 45% decrease in those reporting breast symptoms compared to the control group.
  
        This study has the potential to improve overall patient experience by validating the routine
        use of cabergoline for lactation inhibition in the early second-trimester after abortion or
        pregnancy loss.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of Participants Reporting Breast Pain
  time frame: Day 4 after procedure
  description: Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
  measure: Number of Participants Experiencing Side-effects
  time frame: Cumulative over 2 weeks
  description: Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect.
  measure: Number of Participants Reporting Significant Bother From Breast Pain
  time frame: Day 4 after procedure
  description: Assessed using a Facial Pain Score (scale range 0-6, significant bother >=4)
  measure: Number of Participants Reporting Significant Bother From Side-effects
  time frame: Cumulative over 2 weeks
  description: Assessed using a Facial Pain Score (scale range 0-6, significant bother >=4)
  arm group label: Cabergoline
  arm group type: Experimental
  description: After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
  intervention type: Drug
  intervention name: Cabergoline 1 MG
  description: Dopamine agonist
  arm group label: Cabergoline
  other name: Dosintex
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cabergoline
  sharing ipd: Yes
  ipd description: De-identified data may be requested for meta-analysis inclusion
  ipd info type: Study Protocol