Postpartum RecoveryDECORUMNCT05260242
Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities
A study testing Disparities Conversation in people with Postpartum Recovery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Recovery
- What is being tested?
- Disparities Conversation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 3 Dec 2024
- Phase
- Interventional
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Patients admitted to Labor and Delivery Unit at MSH will self-identify race/ethnicity as part of the standard admission process (Documented in EPIC). Patients who elect for epidural placement for labor epidural analgesia will be approached by an Anesthesia Team Member to be enrolled in a minimal risk study. Participants who self-identify as a racial/ethnic underserved group (as defined by the NIH) will be randomized to receive routine care with a disparities discussion or routine care alone (in a Block Randomization format). Self-identified white participants will receive routine care and serve as a secondary comparison group. The disparities discussion will be performed following epidural placement when the patient is comfortable. During the postpartum period at patient follow-up (within 24hrs postpartum), an 18-point questionnaire evaluating outcomes and patient satisfaction will be administered.
- Conditions
- Postpartum Recovery
- Being tested
- Disparities Conversation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disparities ConversationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conversation | Experimental | Scripted interaction Receives: Other: Disparities Conversation |
| No Conversation | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
DECORUM Questionnaire
DECORUM Questionnaire is split into 2 subscales, scored separately: The first subscale are built from the Obstetric-Quality of Recovery-10 Questionnaire scored from 0-100, with higher score indicating better health outcomes. The second subscale built from the Maryland Cultural Competency Questionnaire scored from 8 - 80, with higher score indicating better health outcomes.
Measured: postpartum Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 May 2023
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Why it stopped: low recruitment lack of support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum RecoveryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Demaria Jr, Icahn School of Medicine at Mount Sinai
- Investigators
- Samuel DeMaria Jr., MD, Principal investigator, Icahn School of Medicine at Mount SinaiAllen Ninh, MD, Study director, Icahn School of Medicine at Mount SinaiDaniel Katz, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260242
- Sponsor's protocol ID
- STUDY-21-00270
- Acronym
- DECORUM
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.