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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

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Postpartum Opioid Use Post-operative Cesarean Delivery Other: Survey

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 Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postpartum Opioid Prescribing Patterns and Patient Utilization
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Groups and Cohorts
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Group/Cohort Intervention/treatment
Post-cesarean delivery
Women who have undergone cesarean delivery
 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
Post-vaginal delivery
Women who have undergone vaginal delivery
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women who are postpartum
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030742


Contacts
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Contact: Nevert Badreldin, MD 312.472.4648 nevert.badreldin@northwestern.edu
Contact: Lynn Yee, MD 312.472.0119 lynn.yee@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Nevert Badreldin, MD    312-472-4648    nevert.badreldin@northwestern.edu   
Sub-Investigator: Nevert Badreldin, MD         
Principal Investigator: Lynn Yee, MD         
Sponsors and Collaborators
Northwestern University
Society for Maternal-Fetal Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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Responsible Party: Lynn M Yee, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03030742     History of Changes
Other Study ID Numbers: NortherwesternU
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents