<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/NCT02970721</url>
  </required_header>
  <id_info>
    <org_study_id>108217</org_study_id>
    <nct_id>NCT02970721</nct_id>
  </id_info>
  <brief_title>Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder</brief_title>
  <official_title>Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder: Patterns, Determinants, and Impact on Perinatal Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of the proposed project are:&#xD;
&#xD;
        1. To describe the patterns of mood stabilizer, antipsychotic, antidepressant, and&#xD;
           anxiolytic prescriptions during pregnancy over a period of 12 years (2002-2014) in women&#xD;
           aged 13 to 50 years who are diagnosed with bipolar disorder in Ontario.&#xD;
&#xD;
        2. To identify the factors associated with use of antipsychotics, antidepressants, and&#xD;
           antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar&#xD;
           disorder.&#xD;
&#xD;
        3. To assess the impact of antipsychotics, antidepressants, and&#xD;
           antipsychotic-antidepressant polytherapy on the risk of maternal, neonatal, and labour&#xD;
           and delivery outcomes in women with bipolar disorder.&#xD;
&#xD;
        4. To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant&#xD;
           polytherapy on psychiatric readmission rates during the early postpartum period in women&#xD;
           with bipolar disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal Outcomes (pregnancy)</measure>
    <time_frame>2002-2014</time_frame>
    <description>Venous Thromboembolism, gestational diabetes, gestational hypertension, preeclampsia or eclampsia, placental abruption, placental infarction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neonatal Outcomes</measure>
    <time_frame>2002-2014</time_frame>
    <description>Preterm birth, small for gestational age, large for gestational age, sepsis, mortality, infection, neonatal adaption syndrome, respiratory distress syndrome, seizure, intraventricular haemorrhage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal Outcomes</measure>
    <time_frame>2002-2014</time_frame>
    <description>Stillbirth, congenital malformation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Labour and Delivery Outcomes</measure>
    <time_frame>2002-2014</time_frame>
    <description>Caesarean, forceps/ventouse, induced labour, episiotomy or delivery with tear (3rd or 4th degree)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychiatric Readmission</measure>
    <time_frame>2002-2014</time_frame>
    <description>Readmission for mental health reasons ≤ 7 days post-delivery, readmission for mental health reasons within 1 to 12 weeks post-delivery</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3357</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Bipolar disorder-treated</arm_group_label>
    <description>Individuals in this group are taking any medication (mood stabilizer, antipsychotic, antidepressants, antianxiety) during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bipolar Disorder-Not Treated</arm_group_label>
    <description>Individuals in this group are not taking any medications during pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antipsychotic</intervention_name>
    <description>Antipsychotic monotherapy</description>
    <arm_group_label>Bipolar disorder-treated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antidepressant</intervention_name>
    <description>Antidepressant monotherapy</description>
    <arm_group_label>Bipolar disorder-treated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antipsychotic and Antidepressant</intervention_name>
    <description>Polytherapy</description>
    <arm_group_label>Bipolar disorder-treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women between the ages of 13 and 50 years who were hospitalized for a singleton obstetrical&#xD;
        delivery between 2002-2014. Additionally, these women must be covered under the provincial&#xD;
        drug benefit plan during index pregnancy, which is defined as having filled a drug&#xD;
        prescription in the period from six months prior to pregnancy to six months after delivery.&#xD;
        For women who had multiple pregnancies over the study period, we will select their first&#xD;
        pregnancy as the index pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women were included in our study cohort if they met at least one of the following criteria:&#xD;
        (i) an inpatient hospitalization with a primary discharge diagnosis of BD prior to the&#xD;
        index pregnancy; (ii) an outpatient OHIP fee code for a mood disorder plus a prescription&#xD;
        of a mood stabilizer prior to the index pregnancy (note that the outpatient OHIP fee code&#xD;
        (296) without a prescription would not have been sufficient to identify BD patients because&#xD;
        the fee code is used concurrently used for diagnosis of unipolar depression). Additionally,&#xD;
        women were included in the study cohort if they were continuously covered for ODB&#xD;
        throughout their pregnancy, defined as having filled any provincially funded drug&#xD;
        prescription within six months prior to conception and another either during their&#xD;
        pregnancy or within six months after delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) women with gestational weeks less than 20 and more than 45 at delivery; (2) pregnancies&#xD;
        with multiple overlapping records over the study time period; (3) any data with&#xD;
        inconsistencies and duplicate records for pregnancy; (4) any woman sharing the newborn's&#xD;
        IKN, given that we would be unable to differentiate between the two persons; (5)&#xD;
        observations with missing birth date for the baby and the time period between the mother's&#xD;
        admission and discharge date greater than 14 days (since we were unable to determine the&#xD;
        conception date for these women; and (6) women who filled a treatment prescription up to 30&#xD;
        days prior to pregnancy and none during the period of pregnancy.very&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Boden R, Lundgren M, Brandt L, Reutfors J, Andersen M, Kieler H. Risks of adverse pregnancy and birth outcomes in women treated or not treated with mood stabilisers for bipolar disorder: population based cohort study. BMJ. 2012 Nov 8;345:e7085. doi: 10.1136/bmj.e7085.</citation>
    <PMID>23137820</PMID>
  </reference>
  <reference>
    <citation>Vigod SN, Gomes T, Wilton AS, Taylor VH, Ray JG. Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study. BMJ. 2015 May 13;350:h2298. doi: 10.1136/bmj.h2298.</citation>
    <PMID>25972273</PMID>
  </reference>
  <reference>
    <citation>Broeks SC, Thisted Horsdal H, Glejsted Ingstrup K, Gasse C. Psychopharmacological drug utilization patterns in pregnant women with bipolar disorder - A nationwide register-based study. J Affect Disord. 2017 Mar 1;210:158-165. doi: 10.1016/j.jad.2016.12.001. Epub 2016 Dec 8.</citation>
    <PMID>28040641</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Kelly Anderson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>bipolar disorder</keyword>
  <keyword>adverse outcomes</keyword>
  <keyword>readmission</keyword>
  <keyword>polytherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antipsychotic Agents</mesh_term>
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_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/NCT02970721
org study id: 108217
nct id: NCT02970721
lead sponsor: 
has dmc: No
The objectives of the proposed project are:

        1. To describe the patterns of mood stabilizer, antipsychotic, antidepressant, and
           anxiolytic prescriptions during pregnancy over a period of 12 years (2002-2014) in women
           aged 13 to 50 years who are diagnosed with bipolar disorder in Ontario.

        2. To identify the factors associated with use of antipsychotics, antidepressants, and
           antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar
           disorder.

        3. To assess the impact of antipsychotics, antidepressants, and
           antipsychotic-antidepressant polytherapy on the risk of maternal, neonatal, and labour
           and delivery outcomes in women with bipolar disorder.

        4. To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant
           polytherapy on psychiatric readmission rates during the early postpartum period in women
           with bipolar disorder.
observational model: Cohort
time perspective: Retrospective
measure: Maternal Outcomes (pregnancy)
time frame: 2002-2014
description: Venous Thromboembolism, gestational diabetes, gestational hypertension, preeclampsia or eclampsia, placental abruption, placental infarction
measure: Neonatal Outcomes
time frame: 2002-2014
description: Preterm birth, small for gestational age, large for gestational age, sepsis, mortality, infection, neonatal adaption syndrome, respiratory distress syndrome, seizure, intraventricular haemorrhage
measure: Fetal Outcomes
time frame: 2002-2014
description: Stillbirth, congenital malformation
measure: Labour and Delivery Outcomes
time frame: 2002-2014
description: Caesarean, forceps/ventouse, induced labour, episiotomy or delivery with tear (3rd or 4th degree)
measure: Psychiatric Readmission
time frame: 2002-2014
description: Readmission for mental health reasons ≤ 7 days post-delivery, readmission for mental health reasons within 1 to 12 weeks post-delivery
arm group label: Bipolar disorder-treated
description: Individuals in this group are taking any medication (mood stabilizer, antipsychotic, antidepressants, antianxiety) during pregnancy
arm group label: Bipolar Disorder-Not Treated
description: Individuals in this group are not taking any medications during pregnancy
intervention type: Drug
intervention name: Antipsychotic
description: Antipsychotic monotherapy
arm group label: Bipolar disorder-treated
intervention type: Drug
intervention name: Antidepressant
description: Antidepressant monotherapy
arm group label: Bipolar disorder-treated
intervention type: Drug
intervention name: Antipsychotic and Antidepressant
description: Polytherapy
arm group label: Bipolar disorder-treated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: No
citation: Boden R, Lundgren M, Brandt L, Reutfors J, Andersen M, Kieler H. Risks of adverse pregnancy and birth outcomes in women treated or not treated with mood stabilisers for bipolar disorder: population based cohort study. BMJ. 2012 Nov 8;345:e7085. doi: 10.1136/bmj.e7085.
PMID: 23137820
citation: Vigod SN, Gomes T, Wilton AS, Taylor VH, Ray JG. Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study. BMJ. 2015 May 13;350:h2298. doi: 10.1136/bmj.h2298.
PMID: 25972273
citation: Broeks SC, Thisted Horsdal H, Glejsted Ingstrup K, Gasse C. Psychopharmacological drug utilization patterns in pregnant women with bipolar disorder - A nationwide register-based study. J Affect Disord. 2017 Mar 1;210:158-165. doi: 10.1016/j.jad.2016.12.001. Epub 2016 Dec 8.
PMID: 28040641
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Kelly Anderson
investigator title: Assistant Professor
mesh term: Pregnancy Complications
mesh term: Bipolar Disorder
mesh term: Antipsychotic Agents
mesh term: Antidepressive Agents