Pain ManagementNCT04601246
Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity
An observational study of Pain Management and Opioid Use, run by Northwestern University at 1 site in United States.
Trial summary
This study will evaluate women's experiences with pain management and perceived attitudes regarding opioid use for postpartum pain management and examine differences by race/ ethnicity. Women will participate in in-depth qualitative interviews regarding their postpartum pain experience after a cesarean delivery. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pain Management, Opioid Use, Postpartum Health
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Dec 2021
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant and postpartum women are the primary focus of this investigation.
Who may be able to join
- Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
- 16 years or older
- Low-income socioeconomic status (publicly funded prenatal care or uninsured)
- Ability to speak and read English and/or Spanish
- Planned or experienced cesarean delivery
Who cannot join
- HIV (as these patients already receive intensive social support and navigation-like services)
- Prior pregnancy in which individual declined participation
- Recent COVID-19 positive test, unless patient is asymptomatic and can conduct the study visit via video conference
- Contraindication to opioid or non-steroidal anti-inflammatory drugs
- Non-opioid naïve (defined as ≥3 opioid prescriptions in the year prior to recruitment)
- Use of general anesthesia for delivery
- Postpartum intensive care unit admission
- Known substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: The Postpartum Pain Experience - Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity
This study will evaluate women's experiences with pain management and perceived attitudes regarding opioid use for postpartum pain management and examine differences by race/ ethnicity. Women will participate in in-depth qualitative interviews regarding their postpartum pain experience after a cesarean delivery. In this cohort, the investigators will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity. When applicable, mixed methods integration of patient-reported and clinical data from NNM2 will also allow exploration of patient factors contributing to such variation.
Read the detailed description
Opioid misuse has been declared a national emergency in the United States. Although the opioid epidemic has touched all communities, there is a differential impact based on race and ethnicity. In particular, data has shown that individuals of minority race/ ethnicity are less likely to receive an opioid for pain management than non- Hispanic white individuals. As birth is the most common reason for hospitalization, women of reproductive age are particularly vulnerable to opioid exposure and to experiencing disparities in pain management. Indeed, our data have demonstrated the high frequency of inpatient and outpatient opioid use and wide variation in management of postpartum pain. Notably, data has shown that, despite reporting higher levels of pain postpartum, minority race/ ethnicity women receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. Despite this plethora of quantitative data, few reports have explored women's perspectives on the postpartum pain experience and disparities therein.
The investigators propose a qualitative study of women's experience with pain management in the postpartum period. This proposal aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of women's postpartum pain experiences, with a focus on racial/ ethnic disparities. The investigators will conduct in-depth interviews on the postpartum pain experience among low-income women who have undergone cesarean delivery.
The first interview will be approximately 60 minutes long and will take place during the postpartum hospitalization during days 1 through 4. All efforts will be made to interview the participant at a time when she is comfortable, free of distraction, and not experiencing any medical complications. Interviews will be conducted privately in the participant's hospital room. All guests will be asked to leave the room for the interview and clinical interruptions will be minimized. Interviewers will be trained in the confidential and sensitive conduct of interviews about these topics. Interviews will be conducted by experienced research personnel trained to perform in-depth, unbiased, professional interviews and who are fluent in English and Spanish. The second interview will be by phone for 2 to 4 weeks after hospital discharge that will last approximately 45 minutes.
Interview topics will address identify themes related to autonomy, respect, cultural views on pain management, feeling heard/valued, communication with care team, understanding pain management options, medication administration timing, and perceptions of provider judgment related to opioids. This interview will also ask participants to self-identify their race and ethnicity. Interviews will be audio-recorded. After completion of the interviews, the digital audio files will be professionally transcribed prior to analysis.
This project takes an innovative approach in targeting health disparities in racial/ ethnic minorities, who are disproportionately affected by maternal mortality and severe maternal morbidity. Optimizing postpartum health, reducing opioid overuse, and reducing disparities in care and outcomes are critical goals of major professional societies and the NICHD 2020 strategic plan. Understand the postpartum pain experience will inform future implementation studies by providing an essential missing piece: women's voices and perspectives. Furthermore, this work aims to identify root causes of racial/ ethnic disparities in postpartum opioid use and pain management and allow a foundation from which to enact systems and policies which guard against such disparities.
- Conditions
- Pain Management, Opioid Use, Postpartum Health, Cesarean Delivery
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
Through analysis of qualitative interviews, themes such as satisfaction, engagement, respect, and preferences will be reviewed, and the constant comparative method will be applied.
Measured: 24-48 hours after delivery
Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
Through analysis of qualitative interviews, themes such as satisfaction, engagement, respect, and preferences will be reviewed, and the constant comparative method will be applied.
Measured: 2-4 weeks after hospital discharge
Differences in postpartum pain experiences by maternal race/ethnicity
Through analysis of qualitative interviews, we will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity.
Measured: 24-48 hours after delivery
Differences in postpartum pain experiences by maternal race/ethnicity
Through analysis of qualitative interviews, we will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity.
Measured: 2-4 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nevert Badreldin, Northwestern University
- Investigators
- Nevert Badreldin, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601246
- Sponsor's protocol ID
- 3R01HD098178-02S1
- Other IDs
- 3R01HD098178-02S1
- Status last verified
- Jan 2022
- First submitted
- 6 Oct 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postpartum Pain Experience - Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity
- ClinicalTrials.gov ID
- NCT04601246
- Acronym / sponsor ID
- 3R01HD098178-02S1
- Conditions
- Pain Management, Opioid Use, Postpartum Health, Cesarean Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate women's experiences with pain management and perceived attitudes regarding opioid use for postpartum pain management and examine differences by race/ ethnicity. Women will participate in in-depth qualitative interviews regarding their postpartum pain experience after a cesarean delivery. In this cohort, the investigators will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity. When applicable, mixed methods integration of patient-reported and clinical data from NNM2 will also allow exploration of patient factors contributing to such variation.
Detailed description
Opioid misuse has been declared a national emergency in the United States. Although the opioid epidemic has touched all communities, there is a differential impact based on race and ethnicity. In particular, data has shown that individuals of minority race/ ethnicity are less likely to receive an opioid for pain management than non- Hispanic white individuals. As birth is the most common reason for hospitalization, women of reproductive age are particularly vulnerable to opioid exposure and to experiencing disparities in pain management. Indeed, our data have demonstrated the high frequency of inpatient and outpatient opioid use and wide variation in management of postpartum pain. Notably, data has shown that, despite reporting higher levels of pain postpartum, minority race/ ethnicity women receive less opioid treatment as inpatients and are less frequently prescribed an opioid upon hospital discharge. Despite this plethora of quantitative data, few reports have explored women's perspectives on the postpartum pain experience and disparities therein.
The investigators propose a qualitative study of women's experience with pain management in the postpartum period. This proposal aims to fill an unmet need for a systematic, in-depth, and unbiased evaluation of women's postpartum pain experiences, with a focus on racial/ ethnic disparities. The investigators will conduct in-depth interviews on the postpartum pain experience among low-income women who have undergone cesarean delivery.
The first interview will be approximately 60 minutes long and will take place during the postpartum hospitalization during days 1 through 4. All efforts will be made to interview the participant at a time when she is comfortable, free of distraction, and not experiencing any medical complications. Interviews will be conducted privately in the participant's hospital room. All guests will be asked to leave the room for the interview and clinical interruptions will be minimized. Interviewers will be trained in the confidential and sensitive conduct of interviews about these topics. Interviews will be conducted by experienced research personnel trained to perform in-depth, unbiased, professional interviews and who are fluent in English and Spanish. The second interview will be by phone for 2 to 4 weeks after hospital discharge that will last approximately 45 minutes.
Interview topics will address identify themes related to autonomy, respect, cultural views on pain management, feeling heard/valued, communication with care team, understanding pain management options, medication administration timing, and perceptions of provider judgment related to opioids. This interview will also ask participants to self-identify their race and ethnicity. Interviews will be audio-recorded. After completion of the interviews, the digital audio files will be professionally transcribed prior to analysis.
This project takes an innovative approach in targeting health disparities in racial/ ethnic minorities, who are disproportionately affected by maternal mortality and severe maternal morbidity. Optimizing postpartum health, reducing opioid overuse, and reducing disparities in care and outcomes are critical goals of major professional societies and the NICHD 2020 strategic plan. Understand the postpartum pain experience will inform future implementation studies by providing an essential missing piece: women's voices and perspectives. Furthermore, this work aims to identify root causes of racial/ ethnic disparities in postpartum opioid use and pain management and allow a foundation from which to enact systems and policies which guard against such disparities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant and postpartum women are the primary focus of this investigation.
Key inclusion criteria (5 listed)
- Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
- 16 years or older
- Low-income socioeconomic status (publicly funded prenatal care or uninsured)
- Ability to speak and read English and/or Spanish
- Planned or experienced cesarean delivery
Key exclusion criteria (8 listed)
- HIV (as these patients already receive intensive social support and navigation-like services)
- Prior pregnancy in which individual declined participation
- Recent COVID-19 positive test, unless patient is asymptomatic and can conduct the study visit via video conference
- Contraindication to opioid or non-steroidal anti-inflammatory drugs
- Non-opioid naïve (defined as ≥3 opioid prescriptions in the year prior to recruitment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
Time frame: 24-48 hours after delivery
Through analysis of qualitative interviews, themes such as satisfaction, engagement, respect, and preferences will be reviewed, and the constant comparative method will be applied.
Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
Time frame: 2-4 weeks after hospital discharge
Through analysis of qualitative interviews, themes such as satisfaction, engagement, respect, and preferences will be reviewed, and the constant comparative method will be applied.
Differences in postpartum pain experiences by maternal race/ethnicity
Time frame: 24-48 hours after delivery
Through analysis of qualitative interviews, we will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity.
Differences in postpartum pain experiences by maternal race/ethnicity
Time frame: 2-4 weeks after hospital discharge
Through analysis of qualitative interviews, we will evaluate how experiences of postpartum pain management and perceptions of provider attitudes vary across self-identified race/ethnicity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevert Badreldin, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Opioid Use, 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 5 inclusion and 8 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 4 Jan 2022. 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?
Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management (time frame: 24-48 hours after delivery). The study lists 4 primary outcomes in all. 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 4 Jan 2022.