Helping postpartum women with gestational diabetes and hypertension connect to primary care
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
This study is testing if extra support, like patient education and motivational texts, can help new moms with gestational diabetes and high blood pressure get better care after childbirth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05852054 on ClinicalTrials.gov |
What this trial studies
STEP-UP aims to improve the transition of postpartum women with a history of gestational diabetes mellitus (GDM) and hypertensive disorders of pregnancy (HDP) to primary care. The study employs a stepped wedge design to compare the effectiveness of enhanced support interventions, including electronic health record-based clinical decision support, patient education during obstetric visits, and motivational text messaging, against usual care. The goal is to increase patient knowledge of reproductive risks, encourage self-care behaviors, and improve clinical measures such as hemoglobin A1c and blood pressure. The study also focuses on providing individualized outreach for those needing additional assistance in accessing primary care.
Who should consider this trial
Good fit: Ideal candidates are postpartum women aged 18 or older who have a history of gestational diabetes or hypertensive disorders during pregnancy and have attended at least one prenatal care visit.
Not a fit: Patients who do not have a history of gestational diabetes or hypertensive disorders during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve health outcomes for postpartum women by ensuring they receive necessary ongoing care and support.
How similar studies have performed: Other studies have shown success in using similar approaches to improve care transitions and chronic disease management in postpartum populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Delivered during an accrual period, * Had a chart diagnosis during their index pregnancy of GDM and/or HDP, * Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery, * Speak English or Spanish, * Age 18 or older
Where this trial is running
Chicago, Illinois and 1 other locations
- Cook County Health — Chicago, Illinois, United States (Recruiting)
- AllianceChicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Stacy Bailey, PhD MPH — Northwestern University
- Study coordinator: Stacy Bailey, PhD MPH
- Email: stacy-bailey@northwestern.edu
- Phone: 312-503-5595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.