Clinical trial NCT03030742: Postpartum Opioid Prescribing Patterns and Patient Utilization
Official title: Postpartum Opioid Prescribing Patterns and Patient Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum
Opioid Use
Post-operative
Cesarean Delivery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Society for Maternal-Fetal Medicine
First posted: 2017-01-25
Enrollment: 494
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are postpartum

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.

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.

Primary outcomes:
measure: Postpartum outpatient opioid use
timeFrame: 8 weeks
Secondary outcomes:
measure: Satisfaction with outpatient pain control
timeFrame: 8 weeks from time of hospital discharge
measure: Proper disposal/storage of remaining opioid tablets
timeFrame: 8 weeks from time of discharge
measure: High opioid use
timeFrame: 8 weeks from time of hospital discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Nevert Badreldin, MD
role: PRINCIPAL_INVESTIGATOR
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