Understanding the Postpartum Pain Experience in Women of Minority Race/Ethnicity

NCT04601246 | Completed

• 1 other identifier: 3R01HD098178-02S1
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Opioid Use; Postpartum Health; Cesarean Delivery

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  2-4 weeks after hospital discharge

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant and postpartum women are the primary focus of this investigation.

You may qualify if:

• Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nevert Badreldin, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology (Maternal Fetal Medicine)

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 23, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)