1500 Participants Needed

Postpartum Care Support for Gestational Diabetes and Hypertension

Recruiting at 1 trial location
SB
GW
CU
Overseen ByChristina Urbina, MBA
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the postpartum care support for gestational diabetes and hypertension generally safe for humans?

The research articles provided do not contain specific safety data for the postpartum care support treatment for gestational diabetes and hypertension. However, they emphasize the importance of communication and education in improving patient safety and care outcomes in obstetric settings.12345

How does this treatment for postpartum care support in gestational diabetes and hypertension differ from other treatments?

This treatment is unique because it focuses on improving postpartum care through educational toolkits and quality improvement initiatives, which aim to enhance clinical practices and increase follow-up visits and screenings for type 2 diabetes in women with a history of gestational diabetes. Unlike standard treatments that may not emphasize postpartum follow-up, this approach seeks to improve coordination between prenatal and postpartum care providers.678910

What data supports the effectiveness of the treatment OB Provider Clinical Decision Support (CDS), Patient Education, and other components for postpartum care in gestational diabetes and hypertension?

Research shows that using educational toolkits and quality improvement initiatives can improve prenatal education and screening rates for gestational diabetes, although postpartum care still needs better coordination. Additionally, patient navigation and virtual connections in prenatal care models have been effective in improving care coordination and patient engagement, which could be beneficial for postpartum care.17111213

Who Is on the Research Team?

SB

Stacy Bailey, PhD MPH

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery
Delivered during an accrual period
You were diagnosed with gestational diabetes or high blood pressure during your previous pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

STEP-UP intervention promoting linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP

6 months
Regular OB and primary care visits

Follow-up

Participants are monitored for completion of primary care visits and dysglycemia testing

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • OB Provider Clinical Decision Support (CDS)
  • Patient Education (OB Visit)
  • Patient Education (Primary Care Visit)
  • Patient Outreach
  • Primary Care Provider Clinical Decision Support (CDS)
  • Text messaging
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Group II: STEP-UPActive Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

AllianceChicago

Collaborator

Trials
8
Recruited
18,700+

Cook County Health

Collaborator

Trials
47
Recruited
16,800+

Published Research Related to This Trial

An 18-month quality improvement project involving 15 clinical practices aimed to enhance postpartum Type 2 diabetes screening rates in women with a history of gestational diabetes, resulting in 67% of women having a documented postpartum visit and 33% undergoing T2DM screening.
The project successfully improved the delivery of patient education on important topics like GDM screening and T2DM risk reduction, but highlighted ongoing challenges in communication between prenatal and postpartum care providers that hindered optimal care.
The Ohio Gestational Diabetes Postpartum Care Learning Collaborative: Development of a Quality Improvement Initiative to Improve Systems of Care for Women.Shellhaas, C., Conrey, E., Crane, D., et al.[2023]
A statewide program in Maine successfully educated healthcare providers and women with pregestational diabetes about preconception counseling, leading to improved pregnancy outcomes.
Women who received preconception counseling had significantly lower rates of congenital defects (1.6%) and fetal or neonatal deaths (6.4%) compared to those who did not receive counseling, where the rates were 6.5% and 21.1%, respectively.
The impact of preconception counseling on pregnancy outcomes. The experience of the Maine Diabetes in Pregnancy Program.Willhoite, MB., Bennert, HW., Palomaki, GE., et al.[2019]
The OB Nest prenatal care model, which includes fewer in-person visits supplemented by virtual connections and home monitoring, aims to maintain or improve patient satisfaction and care continuity for low-risk pregnant women.
This study will evaluate both the effectiveness and feasibility of the OB Nest model compared to standard care, using a mixed-methods approach to gather insights on patient satisfaction, health outcomes, and implementation experiences from both patients and providers.
Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study.Ridgeway, JL., LeBlanc, A., Branda, M., et al.[2022]

Citations

The Ohio Gestational Diabetes Postpartum Care Learning Collaborative: Development of a Quality Improvement Initiative to Improve Systems of Care for Women. [2023]
The impact of preconception counseling on pregnancy outcomes. The experience of the Maine Diabetes in Pregnancy Program. [2019]
Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. [2022]
Web-Based Perinatal Education for the New Obstetrical Patient: A Quality Improvement Project. [2023]
Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. [2023]
Source of Prenatal Care and Nonreceipt of Postpartum Health Care in the United States. [2022]
Obstetric patient safety: an overview. [2012]
Patient education: bridging the gap between inpatient and ambulatory care. [2007]
Obstetrician-Gynecologist Views of Pregnancy-Related Medication Safety. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Improving Postpartum and Long-Term Health After an Adverse Pregnancy Outcome: Examining Interventions From a Health Equity Perspective. [2023]
Postpartum care of women with gestational diabetes: survey of healthcare professionals. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Obstetricians seldom provide postpartum diabetes screening for women with gestational diabetes. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Patient counseling increases postpartum follow-up in women with gestational diabetes mellitus. [2021]
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