Postpartum Opioid Prescribing Patterns and Patient Utilization
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ClinicalTrials.gov Identifier: NCT03030742 |
Recruitment Status :
Completed
First Posted : January 25, 2017
Last Update Posted : February 25, 2020
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Tracking Information | |||||
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First Submitted Date | January 23, 2017 | ||||
First Posted Date | January 25, 2017 | ||||
Last Update Posted Date | February 25, 2020 | ||||
Actual Study Start Date | June 1, 2017 | ||||
Actual Primary Completion Date | August 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Women who are postpartum | ||||
Condition |
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Intervention | Other: Survey
A survey will be administered at two time points (time of hospital discharge and 2-4 weeks postpartum) to determine:
Other Name: Survey/Questionnaire
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
494 | ||||
Original Estimated Enrollment |
700 | ||||
Actual Study Completion Date | December 31, 2019 | ||||
Actual Primary Completion Date | August 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
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 |
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IPD Sharing Statement |
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Current Responsible Party | Lynn M Yee, Northwestern University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Northwestern University | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Society for Maternal-Fetal Medicine | ||||
Investigators |
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PRS Account | Northwestern University | ||||
Verification Date | February 2020 |