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OPTIMIZE Program for Pregnancy Care

Phase 3
Recruiting
Led By Melissa A Simon, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 15 to 45 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 months, and 6 months postpartum
Awards & highlights

Study Summary

This trial will test a new intervention called OPTIMIZE to help African American pregnant women. OPTIMIZE includes using a perinatal checklist and patient navigation support.

Who is the study for?
The OPTIMIZE study is for English-speaking African American women aged 15 to 45 who are currently pregnant or have given birth within the last six months. It's not open to those who are incarcerated, unable to consent, or have cognitive impairments.Check my eligibility
What is being tested?
This trial is testing an intervention called OPTIMIZE, which involves clinic staff using a perinatal checklist and providing patient navigation support. Clinics will either use OPTIMIZE or continue with standard care, decided by random assignment.See study design
What are the potential side effects?
Since this study focuses on improving healthcare delivery rather than medication, it does not involve typical drug side effects. However, there may be indirect effects related to changes in care management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 15 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3 months, and 6 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, and 6 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
Receipt of Perinatal Care Components
Secondary outcome measures
Rate of Tetanus, Diphtheria, Pertussis vaccine uptake
Rate of breastfeeding
Rate of depressive symptoms
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OPTIMIZEExperimental Treatment1 Intervention
This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support.
Group II: Standard CareActive Control1 Intervention
This arm includes provision of standard perinatal care.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
916,631 Total Patients Enrolled
Melissa A Simon, MDPrincipal InvestigatorNorthwestern University

Media Library

OPTIMIZE Clinical Trial Eligibility Overview. Trial Name: NCT04261894 — Phase 3
Pregnancy Research Study Groups: OPTIMIZE, Standard Care
Pregnancy Clinical Trial 2023: OPTIMIZE Highlights & Side Effects. Trial Name: NCT04261894 — Phase 3
OPTIMIZE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04261894 — Phase 3

Frequently Asked Questions

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

Is this research project open to enrollment at the moment?

"According to the online database, this trial is still open for enrollment. It was first published on June 23rd 2021 and later modified on February 1st 2022."

Answered by AI

How many individuals have been recruited to participate in this clinical experiment?

"Affirmative. The information on clinicaltrials.gov reveals that this medical investigation is presently enrolling participants, and was first posted on June 23rd 2021 with the latest changes made on February 1st 2022. 600 individuals are being recruited from one study site for participation."

Answered by AI

Is this study open to individuals aged 65 or older?

"Patients that are between 15 and 45 years of age can take part in this study. Additionally, there are 24 clinical trials specifically for minors below the age of 18 and 87 studies focusing on elderly individuals above 65."

Answered by AI

Who has been approved to participate in this experiment?

"This research is welcoming 600 individuals aged 15 to 45 who are pregnant or have recently delivered a baby. Candidates must also be Black/African American, English speaking and comply with the other requirements outlined by our team."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
ACCESS Community Health Network
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
Melissa Simon 2021. "The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04261894.
All > Womens Health
~147 spots leftby Mar 2025
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