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Postpartum Care Support for Gestational Diabetes and Hypertension

Phase 3
Recruiting
Led By Stacy Bailey, PhD MPH
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Age 18 or older, an
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will help pregnant women with prior GDM/HDP get linked to primary care and ongoing care for any chronic health issues.

Who is the study for?
The STEP-UP trial is for postpartum women over 18 who had gestational diabetes or hypertension during pregnancy. Participants must have attended a prenatal care visit at a study site within the last 6 months and speak English or Spanish.Check my eligibility
What is being tested?
This trial tests if patient education, text messaging, outreach, and clinical decision support can help these women transition to primary care for chronic disease management after giving birth.See study design
What are the potential side effects?
Since this trial involves educational and communication interventions rather than medications, there are no direct medical side effects. However, participants may experience increased stress or anxiety from additional follow-ups.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary care visit (PCV) completion
Secondary outcome measures
Completion of dysglycemia testing
Dysglycemia and hypertension cases detected
Orders for dysglycemia testing

Trial Design

2Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Patients will receive the usual standard of care
Group II: STEP-UPActive Control6 Interventions
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,338 Total Patients Enrolled
AllianceChicagoOTHER
6 Previous Clinical Trials
16,393 Total Patients Enrolled
Cook County HealthOTHER_GOV
46 Previous Clinical Trials
15,407 Total Patients Enrolled

Media Library

STEP-UP Clinical Trial Eligibility Overview. Trial Name: NCT05852054 — Phase 3
Gestational Diabetes Research Study Groups: Usual Care, STEP-UP
Gestational Diabetes Clinical Trial 2023: STEP-UP Highlights & Side Effects. Trial Name: NCT05852054 — Phase 3
STEP-UP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852054 — Phase 3

Frequently Asked Questions

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

Has the STEP-UP program received official endorsement from the FDA?

"STEP-UP's safety was graded 3 by the Power team, as this is a Phase 3 study with multiple proof points to its efficacy and safety."

Answered by AI

Is this research project open to participants over the age of 60?

"This clinical trial has been designed to cater for patient aged 18 and above, with the maximum age of 99 being specified in its inclusion criteria."

Answered by AI

Who qualifies to take part in this research endeavor?

"To participate in this research, individuals should possess gestational diabetes and be between 18-99 years of age. The team behind the experiment is hoping to recruit 788 participants."

Answered by AI

Is this medical experiment accepting enrollees presently?

"Clinicaltrials.gov states that this trial, originally posted on June 1st 2023 and last modified on May 9th 2023 is not presently seeking recruits; nevertheless, there are 136 other trials actively recruiting now."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)
Stacy C Bailey 2023. "Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852054.
~525 spots leftby May 2025
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