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Postpartum PainNCT05202795

Postpartum Pain Experience and Attitudes About Opioid Prescribing

An observational study of Postpartum Pain and Pain Management, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting. Read more about this study

Who is it for?
Ages 18 years and older
How many people
46 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 1 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Practicing health care providers in obstetrics/gynecology

Who may be able to join

  • Practicing health care provider in obstetrics/gynecology at Northwestern Medicine

Who cannot join

  • Below the age of 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Provider Perspectives on the Postpartum Pain Experience and Attitudes About Pain Management

This is a prospective qualitative study of obstetric clinicians examining factors which influence their approach to postpartum pain management, their perspectives and preferences of interventions aimed at reducing opioid use, and the biases which may contribute disparities in this setting.

Read the detailed description

Opioid misuse has been declared a national emergency in the United States. More than half of hospitalized patients receive an opioid during their hospitalization. As birth is the most common reason for hospitalization, reproductive-aged individuals are particularly vulnerable to opioid exposure and are an important population for addressing the opioid epidemic. Indeed, data have demonstrated the high frequency of postpartum inpatient and outpatient opioid use, the wide variation in postpartum pain management, the lack of alignment of opioid prescribing with patient reports of pain, and the contributions of obstetric clinicians to opioid prescribing.

The opioid epidemic has a differential impact by race/ethnicity; individuals of minority race/ethnicity are less likely to receive an opioid for pain management than non-Hispanic White individuals. Notably, data show that, despite reporting higher levels of pain postpartum, minority race/ethnicity birthing individuals receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. A complete understanding and, ultimately improvement, of these experiences and reduction in disparities requires a deeper delve into influences which guide clinicians in their management of postpartum pain.

This investigation aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of obstetric clinicians' experience of postpartum pain management. This is a prospective qualitative study of obstetric clinicians, examining factors which influence their approach to postpartum pain management, biases which may contribute to disparities, and their perspectives and preferences of interventions to reduce opioids and improve pain control. Investigators will conduct in-depth semi-structured interviews with up to 50 obstetric clinicians, including physicians, advanced practitioners, and nurses. Aim 1 will evaluate beliefs and factors which influence clinicians' management of postpartum pain, including potential clinician-level biases which may contribute to disparities. Using the Consolidated Framework for Implementation Science, Aim 2 will evaluate clinicians' perspectives and preferences of interventions to reducing postpartum opioid prescribing and improving pain control, in order to optimize the implementation of future interventions.

Medical subject headings
Agnosia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Factors which influence clinicians' management of postpartum pain

    Through analysis of qualitative interviews, themes such as approaches to pain management, awareness of disparities in pain management, and beliefs about cultural and social influences of pain will be reviewed. The constant comparative method will be applied.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. Clinicians' perspectives and preferences for interventions targeted at reducing postpartum opioid prescribing

    Through analysis of qualitative interviews, themes such as knowledge, acceptability, barriers, feasibility, health impact, and perceived need will be reviewed for different types of interventions to reduce opioid prescribing.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05202795
Sponsor's protocol ID
STU00215779
Status last verified
Feb 2023
First submitted
5 Jan 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Pain and Pain Management, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Factors which influence clinicians' management of postpartum pain (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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