Postpartum Opioid Prescribing Patterns and Patient Utilization

Completed

• Conditions: Postpartum; Opioid Use; Post-operative; Cesarean Delivery
• Interventions: Other: Survey

• Registration Number: NCT03030742
• Lead Sponsor: Northwestern University

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 Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Study Start: 2017-06-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 494

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-cesarean delivery	Survey	Women who have undergone cesarean delivery
Post-vaginal delivery	Survey	Women who have undergone vaginal delivery

Primary Outcome Measures

Name	Time	Method
Postpartum outpatient opioid use	8 weeks	Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum

Secondary Outcome Measures

Name	Time	Method
Proper disposal/storage of remaining opioid tablets	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	8 weeks from time of hospital discharge	Comparison of characteristics of women with \>50% remaining versus \<50% remaining of prescribed opioid tablets
Satisfaction with outpatient pain control	8 weeks from time of hospital discharge	Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States