Postpartum Opioid Prescribing Patterns and Patient Utilization

February 24, 2020 updated by: Lynn M Yee, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who are postpartum

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Survey/Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks from time of hospital discharge
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
8 weeks from time of discharge
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
8 weeks from time of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Society for Maternal-Fetal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

August 30, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NortherwesternU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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