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Postpartum Opioid Prescribing Patterns and Patient Utilization

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ClinicalTrials.gov Identifier: NCT03030742
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Society for Maternal-Fetal Medicine
Information provided by (Responsible Party):
Lynn M Yee, Northwestern University

Tracking Information
First Submitted Date January 23, 2017
First Posted Date January 25, 2017
Last Update Posted Date August 21, 2018
Actual Study Start Date June 1, 2017
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2017)
Postpartum outpatient opioid use [ Time Frame: 8 weeks ]
Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03030742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2017)
  • Satisfaction with outpatient pain control [ Time Frame: 8 weeks from time of hospital discharge ]
    Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum
  • Proper disposal/storage of remaining opioid tablets [ Time Frame: 8 weeks from time of discharge ]
    Proportion of patients who report proper disposal/storage of remaining opioid tablets at the time of postpartum survey administered 2-4 weeks postpartum
  • High opioid use [ Time Frame: 8 weeks from time of hospital discharge ]
    Comparison of characteristics of women with >50% remaining versus <50% remaining of prescribed opioid tablets
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Postpartum Opioid Prescribing Patterns and Patient Utilization
Official Title Postpartum Opioid Prescribing Patterns and Patient Utilization
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women who are postpartum
Condition
  • Postpartum
  • Opioid Use
  • Post-operative
  • Cesarean Delivery
Intervention Other: Survey

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
Other Name: Survey/Questionnaire
Study Groups/Cohorts
  • Post-cesarean delivery
    Women who have undergone cesarean delivery
    Intervention: Other: Survey
  • Post-vaginal delivery
    Women who have undergone vaginal delivery
    Intervention: Other: Survey
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2017)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women who deliver during the recruitment period
  • English-speaking
  • Opiate-naïve (as determined by admission medication reconciliation)
  • Receive oral opioid medications during inpatient postpartum admission
  • 18 years or older

Exclusion Criteria:

  • Contraindication to NSAID use
  • Required use of general anesthesia without concurrent neuraxial analgesia
  • Undergo hysterectomy, or unanticipated surgical procedures during the postpartum period
  • Are admitted to the intensive care unit during their admission.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Nevert Badreldin, MD 312.472.4648 nevert.badreldin@northwestern.edu
Contact: Lynn Yee, MD 312.472.0119 lynn.yee@northwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03030742
Other Study ID Numbers NortherwesternU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lynn M Yee, Northwestern University
Study Sponsor Northwestern University
Collaborators Society for Maternal-Fetal Medicine
Investigators Not Provided
PRS Account Northwestern University
Verification Date August 2018