Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05260242

Conditions

Postpartum Recovery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Disparities Conversation

Study Details

Brief summary:

Racial and ethnic disparities in obstetric anesthesia care remains persistent despite studies documenting its existence and calling for action. The goal of this study is to share disparity data with underserved minority groups being admitted to the labor and delivery unit for obstetric care, to reduce mistrust and misconceptions regarding obstetric anesthesia care, and to bridge the cultural gap between patient beliefs and safe anesthetic care and to empower patients through transparency and provide them with the information necessary to make informed decisions about their care, to improve health literacy, and to ultimately improve patient outcomes and satisfaction.

Conditions

Postpartum Recovery

Study ID

NCT05260242

Start date

May 1, 2023

Status verified date

May, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital.
  • Patients of age 18 or greater with a singleton fetus of at least 37 weeks of gestation that present in spontaneous labor, for induction of labor, or augmentation of labor.
  • Patients in the first stage of labor and who have consented for placement of a labor epidural.

Exclusion Criteria:

  • Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion,
  • Patients who present with a coagulopathy or on anticoagulation medications that exclude them from receiving labor epidural analgesia,
  • Patients who do not consent to labor epidural placement, or if they are on a mid-wife service.
  • Patients that are converted to a cesarean delivery following trial of labor

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Conversation

Scripted interaction

no intervention: No Conversation

Control Group

Interventions

Disparities Conversation

The study intervention will be a scripted interaction delivered by an anesthesia healthcare provider to an individual patient admitted to the labor/delivery unit for labor epidural placement and obstetric care. The discussion will highlight current data relating to healthcare disparities in obstetric anesthesia care within underserved groups and will explain various aspects of obstetric anesthesia care in a culturally-sensitive manner.

Primary outcome measure

  • DECORUM Questionnaire [ Time Frame: postpartum Day 1 ]

Central Contacts and Locations

Central contacts

Samuel DeMaria Jr, MD

212-241-7473Samuel.Demariajr@mountsinai.org

Locations

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Allen Ninh, MD

allen.ninh@icahn.mssm.edu

Daniel Katz, MD

daniel.katz@mountsinai.org

Principal Investigator:

Samuel DeMaria Jr.

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 4, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-06-04.