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Empowering Conversations for Postpartum Care (DECORUM Trial)

N/A
Recruiting
Led By Samuel DeMaria Jr., MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Patients who present with a coagulopathy or on anticoagulation medications that exclude them from receiving labor epidural analgesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postpartum day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial will share data on disparities in obstetric anesthesia care with minority groups to reduce mistrust and empower patients to make informed decisions.

Who is the study for?
This trial is for pregnant individuals, 18 or older, with a single baby at least 37 weeks along and in the first stage of labor. They must be admitted to The Mount Sinai Hospital's labor unit and agree to an epidural. It excludes those in severe pain, having a cesarean after trying labor, with blood clotting issues or on certain medications.
What is being tested?
The study aims to improve understanding and trust in obstetric anesthesia care among underserved minorities by sharing information about disparities. It seeks to empower these patients through education during their admission for childbirth.
What are the potential side effects?
Since this intervention involves conversations rather than medical treatments, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older, pregnant with one baby at least 37 weeks along, and in labor or about to be induced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have an epidural due to a bleeding disorder or because I'm on blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postpartum day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and postpartum day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DECORUM Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ConversationExperimental Treatment1 Intervention
Scripted interaction
Group II: No ConversationActive Control1 Intervention
Control Group

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,801 Total Patients Enrolled
Daniel Katz, MDStudy ChairIcahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
919 Total Patients Enrolled
Samuel DeMaria Jr., MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Allen Ninh, MDStudy DirectorIcahn School of Medicine at Mount Sinai

Media Library

Disparities Conversation Clinical Trial Eligibility Overview. Trial Name: NCT05260242 — N/A
Postpartum Research Study Groups: Conversation, No Conversation
Postpartum Clinical Trial 2023: Disparities Conversation Highlights & Side Effects. Trial Name: NCT05260242 — N/A
Disparities Conversation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05260242 — N/A
~17 spots leftby May 2025
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