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Patient Navigation Program for New Mothers Postpartum Care (NNM2 Trial)

N/A
Recruiting
Led By Lynn M Yee, MD, MPH
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to speak and read English or Spanish
16 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-12 weeks and 1 year postpartum
Awards & highlights

NNM2 Trial Summary

This trial is testing whether a program that helps low-income women with postpartum health care results in better health outcomes. The program provides support for a defined set of health services for one year postpartum.

Who is the study for?
This trial is for English or Spanish-speaking low-income women who are at least 16 years old, have had prenatal care at Northwestern Medicine Prentice Ambulatory Care, and are pregnant or postpartum. It's not for those planning to transfer care, with HIV, previously in NNM2, declined participation before, or in conflicting studies.Check my eligibility
What is being tested?
The study tests if a patient navigation program can improve health outcomes for new mothers over one year postpartum. Women will either receive this support program or usual care. The program focuses on overcoming social barriers and promoting self-care and engagement.See study design
What are the potential side effects?
Since the intervention involves non-medical support through patient navigation rather than drugs or medical procedures, traditional side effects aren't expected. However, participants may experience varying levels of emotional impact due to the nature of personal support.

NNM2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can speak and read English or Spanish.
Select...
I am 16 years old or older.

NNM2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-12 weeks and 1 year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-12 weeks and 1 year 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
Postpartum health at 4-12 weeks after delivery
Secondary outcome measures
Breastfeeding duration
Breastfeeding initiation and maintenance (component of )
Experiences with navigation (qualitative)
+12 more
Other outcome measures
Clinician experiences with NNM2
Clinician perspectives on patient navigation
Navigation intensity and activities

NNM2 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Navigation GroupExperimental Treatment1 Intervention
Women who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient after delivery occurs for introductions and education. The patient navigator will offer support and resources (transportation, community referrals, support for your mental health, connection to your doctors, etc.). The navigator will also help to schedule postpartum medical appointments, and will remind the patients of these appointments via text, email, or phone calls. The navigator will continue to provide psychosocial support and continued linkage to resources through one-year postpartum.
Group II: Non-navigation cohortActive Control1 Intervention
No navigation will be provided; women will receive usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation Program
2018
N/A
~110

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,951 Previous Clinical Trials
2,660,386 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,574 Previous Clinical Trials
909,253 Total Patients Enrolled
Lynn M Yee, MD, MPH4.8136 ReviewsPrincipal Investigator - Northwestern University
Medical School - Eastern Virginia Medical School, Doctor of Medicine
University of Southern California, Residency in Internal Medicine
2 Previous Clinical Trials
120 Total Patients Enrolled
5Patient Review
They were very helpful, even going so far as to call me and help me find the location. I saw Nurse Practitioner Tori Butur and she was great.

Media Library

Patient Navigation Program Clinical Trial Eligibility Overview. Trial Name: NCT03922334 — N/A
Postpartum Research Study Groups: Navigation Group, Non-navigation cohort
Postpartum Clinical Trial 2023: Patient Navigation Program Highlights & Side Effects. Trial Name: NCT03922334 — N/A
Patient Navigation Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03922334 — N/A

Frequently Asked Questions

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

To whom is this clinical trial open for enrollment?

"This trial is calling for 400 participants aged 16-50 who have remained engaged in their care. Furthermore, they must be pregnant (20 weeks or later) and/or postpartum at the time of enrollment, from a low-income background with access to publicly funded prenatal care, able to understand either English or Spanish, and registered as an established patient at Northwestern Medicine Prentice Ambulatory Care Clinic site."

Answered by AI

Is the minimum age requirement for this clinical trial less than 18 years old?

"To be accepted as a participant in this study, patients must fall between the age range of 16 to 50. For those younger than 16 and above 65, 39 and 46 trials respectively are available for consideration."

Answered by AI

To what extent has patient participation been achieved for this experiment?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical research project, initially posted on January 21st 2020, is currently recruiting participants. 400 individuals are being recruited from a single location to take part in the trial."

Answered by AI

Are new participants being welcomed into this research endeavor?

"Affirmative. Clinicaltrials.gov states that this research project, which was initially made public on January 21st 2020, is currently searching for participants. Approximately 400 individuals need to be recruited from 1 particular medical facility."

Answered by AI
~77 spots leftby Mar 2025