<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/NCT03030742</url>
  </required_header>
  <id_info>
    <org_study_id>NortherwesternU</org_study_id>
    <nct_id>NCT03030742</nct_id>
  </id_info>
  <brief_title>Postpartum Opioid Prescribing Patterns and Patient Utilization</brief_title>
  <official_title>Postpartum Opioid Prescribing Patterns and Patient Utilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society for Maternal-Fetal Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</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 study seeks to investigate the prescribing patterns and patient utilization of opioid&#xD;
      pain medication in the postpartum setting. Postpartum women will be surveyed prior to&#xD;
      hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid&#xD;
      tablets they used (in relation to the number prescribed), pain satisfaction, and&#xD;
      storage/disposal of any remaining opioid tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opiate abuse is a national epidemic and has paralleled the increase in opioid prescriptions,&#xD;
      with diversion of surplus medication playing a key contributing role. As the majority of&#xD;
      reproductive age women in the U.S. will experience childbirth, understanding opioid&#xD;
      prescription patterns and patient opioid utilization in the postpartum period is critical.&#xD;
&#xD;
      Postpartum women will be recruited during a 9-month period to take part in pre-hospital&#xD;
      discharge and 2-4 week postpartum surveys to prospectively assess opioid medication use with&#xD;
      regard to quantity of opioid tablets prescribed and quantity used, storage and disposal of&#xD;
      unused opioids and satisfaction with pain control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum outpatient opioid use</measure>
    <time_frame>8 weeks</time_frame>
    <description>Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with outpatient pain control</measure>
    <time_frame>8 weeks from time of hospital discharge</time_frame>
    <description>Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proper disposal/storage of remaining opioid tablets</measure>
    <time_frame>8 weeks from time of discharge</time_frame>
    <description>Proportion of patients who report proper disposal/storage of remaining opioid tablets at the time of postpartum survey administered 2-4 weeks postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High opioid use</measure>
    <time_frame>8 weeks from time of hospital discharge</time_frame>
    <description>Comparison of characteristics of women with &gt;50% remaining versus &lt;50% remaining of prescribed opioid tablets</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">494</enrollment>
  <condition>Postpartum</condition>
  <condition>Opioid Use</condition>
  <condition>Post-operative</condition>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Post-cesarean delivery</arm_group_label>
    <description>Women who have undergone cesarean delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-vaginal delivery</arm_group_label>
    <description>Women who have undergone vaginal delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>A survey will be administered at two time points (time of hospital discharge and 2-4 weeks postpartum) to determine:&#xD;
Satisfaction with pain control 2-4 weeks postpartum&#xD;
Patient-reported use of opioid medication postpartum (receipt of prescription, filling of prescription, if refill was obtained, and number of opioid pills remaining at the time of follow-up)&#xD;
Patient characteristics associated with high opioid use&#xD;
Methods of storage and disposal of unused opioids</description>
    <arm_group_label>Post-cesarean delivery</arm_group_label>
    <arm_group_label>Post-vaginal delivery</arm_group_label>
    <other_name>Survey/Questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who are postpartum&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who deliver during the recruitment period&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Opiate-naïve (as determined by admission medication reconciliation)&#xD;
&#xD;
          -  Receive oral opioid medications during inpatient postpartum admission&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to NSAID use&#xD;
&#xD;
          -  Required use of general anesthesia without concurrent neuraxial analgesia&#xD;
&#xD;
          -  Undergo hysterectomy, or unanticipated surgical procedures during the postpartum&#xD;
             period&#xD;
&#xD;
          -  Are admitted to the intensive care unit during their admission.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nevert Badreldin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women--United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013 Jul 5;62(26):537-42.</citation>
    <PMID>23820967</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.</citation>
    <PMID>22048730</PMID>
  </reference>
  <reference>
    <citation>Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.</citation>
    <PMID>22786464</PMID>
  </reference>
  <reference>
    <citation>Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/</citation>
    <PMID>23596641</PMID>
  </reference>
  <reference>
    <citation>Peirce GL, Smith MJ, Abate MA, Halverson J. Doctor and pharmacy shopping for controlled substances. Med Care. 2012 Jun;50(6):494-500. doi: 10.1097/MLR.0b013e31824ebd81.</citation>
    <PMID>22410408</PMID>
  </reference>
  <reference>
    <citation>Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.</citation>
    <PMID>21168869</PMID>
  </reference>
  <reference>
    <citation>Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.</citation>
    <PMID>27631771</PMID>
  </reference>
  <reference>
    <citation>Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.</citation>
    <PMID>26720857</PMID>
  </reference>
  <reference>
    <citation>Paulozzi LJ, Mack KA, Hockenberry JM; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb Mortal Wkly Rep. 2014 Jul 4;63(26):563-8.</citation>
    <PMID>24990489</PMID>
  </reference>
  <reference>
    <citation>Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.</citation>
    <PMID>25821010</PMID>
  </reference>
  <reference>
    <citation>Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.</citation>
    <PMID>26827847</PMID>
  </reference>
  <reference>
    <citation>Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.</citation>
    <PMID>26996986</PMID>
  </reference>
  <reference>
    <citation>Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum In: JAMA Intern Med. 2016 Sep 1;176(9):1412. JAMA Intern Med. 2022 Jun 1;182(6):690. JAMA Intern Med. 2022 Jul 1;182(7):783.</citation>
    <PMID>27400458</PMID>
  </reference>
  <reference>
    <citation>Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.</citation>
    <PMID>26824844</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Lynn M Yee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03030742
org study id: NortherwesternU
nct id: NCT03030742
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study seeks to investigate the prescribing patterns and patient utilization of opioid
      pain medication in the postpartum setting. Postpartum women will be surveyed prior to
      hospital discharge and again at 2-4 weeks postpartum in order to assess the number of opioid
      tablets they used (in relation to the number prescribed), pain satisfaction, and
      storage/disposal of any remaining opioid tablets.
Opiate abuse is a national epidemic and has paralleled the increase in opioid prescriptions,
      with diversion of surplus medication playing a key contributing role. As the majority of
      reproductive age women in the U.S. will experience childbirth, understanding opioid
      prescription patterns and patient opioid utilization in the postpartum period is critical.

      Postpartum women will be recruited during a 9-month period to take part in pre-hospital
      discharge and 2-4 week postpartum surveys to prospectively assess opioid medication use with
      regard to quantity of opioid tablets prescribed and quantity used, storage and disposal of
      unused opioids and satisfaction with pain control.
observational model: Cohort
time perspective: Prospective
measure: Postpartum outpatient opioid use
time frame: 8 weeks
description: Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum
measure: Satisfaction with outpatient pain control
time frame: 8 weeks from time of hospital discharge
description: Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum
measure: Proper disposal/storage of remaining opioid tablets
time frame: 8 weeks from time of discharge
description: Proportion of patients who report proper disposal/storage of remaining opioid tablets at the time of postpartum survey administered 2-4 weeks postpartum
measure: High opioid use
time frame: 8 weeks from time of hospital discharge
description: Comparison of characteristics of women with >50% remaining versus <50% remaining of prescribed opioid tablets
arm group label: Post-cesarean delivery
description: Women who have undergone cesarean delivery
arm group label: Post-vaginal delivery
description: Women who have undergone vaginal delivery
intervention type: Other
intervention name: Survey
description: A survey will be administered at two time points (time of hospital discharge and 2-4 weeks postpartum) to determine:
Satisfaction with pain control 2-4 weeks postpartum
Patient-reported use of opioid medication postpartum (receipt of prescription, filling of prescription, if refill was obtained, and number of opioid pills remaining at the time of follow-up)
Patient characteristics associated with high opioid use
Methods of storage and disposal of unused opioids
arm group label: Post-cesarean delivery
arm group label: Post-vaginal delivery
other name: Survey/Questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Nevert Badreldin, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women--United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013 Jul 5;62(26):537-42.
PMID: 23820967
citation: Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
PMID: 22048730
citation: Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PMID: 22786464
citation: Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/
PMID: 23596641
citation: Peirce GL, Smith MJ, Abate MA, Halverson J. Doctor and pharmacy shopping for controlled substances. Med Care. 2012 Jun;50(6):494-500. doi: 10.1097/MLR.0b013e31824ebd81.
PMID: 22410408
citation: Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
PMID: 21168869
citation: Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PMID: 27631771
citation: Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.
PMID: 26720857
citation: Paulozzi LJ, Mack KA, Hockenberry JM; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb Mortal Wkly Rep. 2014 Jul 4;63(26):563-8.
PMID: 24990489
citation: Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2.
PMID: 25821010
citation: Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
PMID: 26827847
citation: Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
PMID: 26996986
citation: Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum In: JAMA Intern Med. 2016 Sep 1;176(9):1412. JAMA Intern Med. 2022 Jun 1;182(6):690. JAMA Intern Med. 2022 Jul 1;182(7):783.
PMID: 27400458
citation: Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
PMID: 26824844
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Lynn M Yee
investigator title: Assistant Professor
sharing ipd: No