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CompletedNCT03030742Updated Feb 25, 2020

Postpartum Opioid Prescribing Patterns and Patient Utilization

An observational study in Postpartum, Opioid Use and Post-operative, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
494
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Postpartum
  • Opioid Use
  • Post-operative
  • Cesarean Delivery
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In context

Lead sponsor

Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women who are postpartum

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
494 participants (actual)
Patient registry
No

Groups and cohorts

  • Post-cesarean delivery

    Women who have undergone cesarean delivery

    Other: Survey

  • Post-vaginal delivery

    Women who have undergone vaginal delivery

    Other: Survey

Interventions

  • OtherSurvey

    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

    Also known as: Survey/Questionnaire

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What researchers measure

Primary outcomes

  1. Postpartum outpatient opioid use

    Self reported number of opioid tablets used at time of postpartum survey administered 2-4 weeks postpartum

    Time frame: 8 weeks

Secondary outcomes

  1. Satisfaction with outpatient pain control

    Satisfaction with pain control at the time of postpartum survey administered 2-4 weeks postpartum

    Time frame: 8 weeks from time of hospital discharge

  2. Proper disposal/storage of remaining opioid tablets

    Proportion of patients who report proper disposal/storage of remaining opioid tablets at the time of postpartum survey administered 2-4 weeks postpartum

    Time frame: 8 weeks from time of discharge

  3. High opioid use

    Comparison of characteristics of women with \>50% remaining versus \<50% remaining of prescribed opioid tablets

    Time frame: 8 weeks from time of hospital discharge

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Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
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References and documents

Publications

  • Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among women--United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013 Jul 5;62(26):537-42. PubMed 23820967 ↗
  • Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92. PubMed 22048730 ↗
  • Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38. PubMed 22786464 ↗
  • Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/ PubMed 23596641 ↗
  • Peirce GL, Smith MJ, Abate MA, Halverson J. Doctor and pharmacy shopping for controlled substances. Med Care. 2012 Jun;50(6):494-500. doi: 10.1097/MLR.0b013e31824ebd81. PubMed 22410408 ↗
  • Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18. PubMed 21168869 ↗
  • Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993. PubMed 27631771 ↗
  • Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3. PubMed 26720857 ↗
  • Paulozzi LJ, Mack KA, Hockenberry JM; Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb Mortal Wkly Rep. 2014 Jul 4;63(26):563-8. PubMed 24990489 ↗
  • Mkontwana N, Novikova N. Oral analgesia for relieving post-caesarean pain. Cochrane Database Syst Rev. 2015 Mar 29;2015(3):CD010450. doi: 10.1002/14651858.CD010450.pub2. PubMed 25821010 ↗
  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. PubMed 26827847 ↗
  • Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17. PubMed 26996986 ↗
  • Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. PubMed 27400458 ↗
  • Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016. PubMed 26824844 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03030742
Collaborators
Society for Maternal-Fetal Medicine
Responsible party
Lynn M Yee (Assistant Professor, Northwestern University) — Principal investigator
First posted
Jan 25, 2017
Start date
Jun 1, 2017
Primary completion
Aug 30, 2019
Completion
Dec 31, 2019
Last update
Feb 25, 2020

Study contacts

Nevert Badreldin, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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