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Patient Navigation for High-Risk Pregnancy

N/A

Recruiting

Led By Anne L Dunlop, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months postpartum

Awards & highlights

Study Summary

This trial will test if a community-based patient navigator intervention can improve health outcomes for high-risk pregnant women, helping reduce racial disparities.

Who is the study for?

This trial is for Black, English-speaking pregnant women or individuals over 18 years old with Medicaid coverage. They must be less than 20 weeks pregnant with a single baby and have at least one unmet social need. Participants should plan to receive care and deliver at Grady, staying available through the first year postpartum.Check my eligibility

What is being tested?

The study tests if having a community-based patient navigator from mid-pregnancy to one year after birth helps medically underserved women. It compares standard care against this added support in two groups randomly chosen among 540 participants.See study design

What are the potential side effects?

Since this trial involves non-medical intervention (patient navigation), traditional side effects associated with medications are not applicable. However, there may be indirect effects on stress levels or decision-making processes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of SMM and maternal death events

Secondary outcome measures

Change in number of post-delivery maternal morbidity (non-SMM) events

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Participants will receive a community-based patient navigator with 3 prenatal contacts and 5 postpartum contacts; during each contact, the community-based patient navigator will offer health assessment and education, along with group education and social support.

Group II: Comparison Group (Standard of Care)Active Control1 Intervention

Participants will receive the standard of care.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,021 Total Patients Enrolled

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,156 Total Patients Enrolled

Anne L Dunlop, MDPrincipal InvestigatorEmory University

Media Library

Community-based prenatal/perinatal/postpartum patient navigator Clinical Trial Eligibility Overview. Trial Name: NCT05588245 — N/A

Pregnancy Research Study Groups: Comparison Group (Standard of Care), Intervention Group

Pregnancy Clinical Trial 2023: Community-based prenatal/perinatal/postpartum patient navigator Highlights & Side Effects. Trial Name: NCT05588245 — N/A

Community-based prenatal/perinatal/postpartum patient navigator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05588245 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for participants in this investigation?

"According to clinicaltrials.gov, this medical trial is not actively recruiting for participants at the time being. Initially posted on February 1st 2023 and last edited on October 18th 2022, it does not seek candidates presently; however there are 133 other trials in search of volunteers currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Community-based Patient Navigation

Anne Lang Dunlop 2024. "Trial of Community-based Patient Navigation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588245.