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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Condition or disease | Intervention/treatment |
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Postpartum Opioid Use Post-operative Cesarean Delivery | Other: Survey |
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 |
Actual Enrollment : | 494 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Postpartum Opioid Prescribing Patterns and Patient Utilization |
Actual Study Start Date : | June 1, 2017 |
Actual Primary Completion Date : | August 30, 2019 |
Actual Study Completion Date : | December 31, 2019 |
Group/Cohort | Intervention/treatment |
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Post-cesarean delivery
Women who have undergone cesarean delivery
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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 |
Post-vaginal delivery
Women who have undergone vaginal delivery
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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 |
- 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
- 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
- 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
- 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

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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 |
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.

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
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Nevert Badreldin, MD | Northwestern University |
Responsible Party: | Lynn M Yee, Assistant Professor, Northwestern University |
ClinicalTrials.gov Identifier: | NCT03030742 |
Other Study ID Numbers: |
NortherwesternU |
First Posted: | January 25, 2017 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |