Clinical trial NCT04601246: Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity
Official title: The Postpartum Pain Experience - Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Management
Opioid Use
Postpartum Health
Cesarean Delivery
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-10-23
Enrollment: 49
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant and postpartum women are the primary focus of this investigation.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
timeFrame: 24-48 hours after delivery
measure: Themes of pain management and perceived attitudes regarding opioid use for postpartum pain management
timeFrame: 2-4 weeks after hospital discharge
measure: Differences in postpartum pain experiences by maternal race/ethnicity
timeFrame: 24-48 hours after delivery
measure: Differences in postpartum pain experiences by maternal race/ethnicity
timeFrame: 2-4 weeks after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Nevert Badreldin, MD
role: PRINCIPAL_INVESTIGATOR
References: