Postpartum Care Support for Gestational Diabetes and Hypertension

Not currently recruiting at 1 trial location

Overseen By Christina Urbina, MBA

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Northwestern University

Disqualifiers: Diabetes, Hypertension, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist new mothers who experienced gestational diabetes or high blood pressure during pregnancy. It seeks to connect these women to primary care for ongoing health checks after childbirth. Participants will receive education, support, and regular check-ins to ensure optimal care. Women who have recently given birth, had gestational diabetes or pregnancy-related high blood pressure, and attended prenatal care in the last six months may be suitable candidates. The trial compares usual care with a new support program, which includes OB Provider Clinical Decision Support (CDS) and other interventions, to determine which is more effective. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking healthcare advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Clinical Decision Support Systems (CDSS) in maternity care are increasingly common and can enhance safety and outcomes. These systems assist healthcare providers in making better decisions. Although specific safety data for postpartum care support treatments like OB Provider Clinical Decision Support and Primary Care Provider Clinical Decision Support are not detailed, the widespread use of CDSS indicates its acceptance in healthcare settings.

Text messaging interventions have demonstrated positive results in managing conditions like gestational diabetes. Studies suggest that these mobile health tools can improve pregnancy outcomes and aid in lifestyle changes.

Patient education, whether in an OB or primary care setting, is generally considered safe and aims to inform and support patients in managing their health.

Patient outreach, which involves contacting patients to keep them engaged in their care, is also a well-regarded approach for improving health outcomes.

Overall, these components of the STEP-UP trial rely on methods commonly used and well-tolerated in healthcare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to postpartum care, addressing both gestational diabetes and hypertension with a combination of clinical decision support, patient education, and digital outreach. Unlike standard care, which typically involves routine check-ups and medication management, this new approach integrates seamless communication through text messaging and proactive outreach to ensure continuous care and monitoring. By promoting linkage to primary care and ongoing evaluation, this method aims to improve long-term health outcomes for postpartum women, potentially offering a more personalized and efficient care experience.

What evidence suggests that this trial's treatments could be effective for postpartum care support?

Research has shown that many women who experienced gestational diabetes (GDM) or high blood pressure during pregnancy (HDP) often do not continue with specialized care after giving birth. For instance, only about one in three women with GDM and half of those with HDP see a primary care doctor within six months postpartum. The STEP-UP program in this trial aims to change this by helping these women connect with primary care and supporting regular health check-ups. Studies suggest that programs like STEP-UP can improve follow-up care and may lower long-term health risks. Although more research is needed for firm conclusions, early results are promising in closing the gaps in postpartum care. ^{1 6 7 8 9}

Who Is on the Research Team?

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?

Group I: Usual Care Active Control 1 Intervention

Patients will receive the usual standard of care

Group II: STEP-UP Active Control 6 Interventions

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

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 educational intervention provided by a nurse educator significantly increased postpartum diabetes testing rates for women with gestational diabetes mellitus (GDM) from 33% to 53% between two cohorts studied from 2002 to 2009.

The increase in postpartum testing was observed across various racial and ethnic groups, with notable improvements in whites, Latinas, and Asians, highlighting the effectiveness of educational counseling in promoting follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient counseling increases postpartum follow-up in women with gestational diabetes mellitus. Stasenko, M., Liddell, J., Cheng, YW., et al.[2021]

Patient safety in obstetric care is crucial, as it directly impacts health care quality and is influenced by various factors, particularly communication, which is a key contributor to adverse events.

While most women give birth without significant safety incidents, a concerning minority still experience events that could negatively affect their outcomes, highlighting the need for improved safety measures in obstetric practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric patient safety: an overview. Grobman, WA.[2012]

The model curriculum for perinatal education effectively bridged the gap between prenatal care and postpartum support for high-risk inner-city women, enhancing their overall health knowledge.

The interdisciplinary approach not only increased clients' knowledge but also promoted positive behavioral changes, highlighting the importance of comprehensive perinatal education in improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education: bridging the gap between inpatient and ambulatory care. Evans, V., Foley, M., Pagan, L., et al.[2007]

The mixed-methods quality improvement project successfully enhanced a web-based obstetrical perinatal education curriculum, leading to better delivery of evidence-based practices for successful pregnancies.

The initiative improved referral rates for cell-free fetal DNA screening among at-risk populations and received positive feedback from providers regarding the web-based teaching format, although barriers to content completion were identified through patient surveys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Perinatal Education for the New Obstetrical Patient: A Quality Improvement Project. Ellington, K.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 1,190 women, 10.8% reported not receiving postpartum health care, highlighting a significant gap in care after childbirth.

Women who did not receive any prenatal care were 8.7 times more likely to miss postpartum health care compared to those who received care from private facilities, indicating that any form of prenatal care is crucial for ensuring postpartum health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Source of Prenatal Care and Nonreceipt of Postpartum Health Care in the United States. Gondwe, T., Simuzingili, M., Green, TL.[2022]

A survey of 106 healthcare professionals revealed that nearly all provided dietary (99%) and exercise (92%) advice to women with gestational diabetes postpartum, indicating a strong emphasis on lifestyle modifications.

However, there was a significant lack of consensus on the responsibility for postpartum diabetes screening and a general underestimation of the future diabetes risk among midwives and obstetricians, highlighting the need for improved education and clear guidelines in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum care of women with gestational diabetes: survey of healthcare professionals. Rayanagoudar, G., Moore, M., Zamora, J., et al.[2022]

Only 20% of women with a history of gestational diabetes received recommended postpartum diabetes screening from obstetrician-gynecologists, highlighting a significant gap in care.

Even when including referrals to primary care for screening, only 33.3% of women were adequately followed up, indicating a need for improved screening practices in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetricians seldom provide postpartum diabetes screening for women with gestational diabetes. Almario, CV., Ecker, T., Moroz, LA., et al.[2022]

Gestational diabetes and hypertensive disorders affect 15% of pregnancies in the U.S. and can lead to long-term health issues, including increased risks of cardiovascular and chronic diseases later in life.

Timely postpartum follow-up and transition to primary care are crucial for preventing future health problems after these adverse pregnancy outcomes, and interventions should consider racial and ethnic disparities to promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Postpartum and Long-Term Health After an Adverse Pregnancy Outcome: Examining Interventions From a Health Equity Perspective. Ditosto, JD., Roytman, MV., Dolan, BM., et al.[2023]

A survey of 506 obstetrician-gynecologists revealed that they frequently access medication safety information during clinical visits, highlighting the need for better resources to support this practice.

Younger physicians are more likely to provide 'safe lists' of medications to patients, but there is a notable lack of counseling for reproductive-aged women who are not actively planning a pregnancy, indicating a gap in communication about medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetrician-Gynecologist Views of Pregnancy-Related Medication Safety. SteelFisher, GK., Hero, JO., Caporello, HL., et al.[2023]

A study involving 28 primary care clinicians revealed strong support for implementing a postpartum patient navigation program to improve care coordination for individuals transitioning from obstetric to primary care.

Clinicians identified key navigation services that could enhance postpartum care, such as personalized support, effective visit management, and education on common postpartum health issues, highlighting the importance of tailored navigator training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. Filicko, A., Huennekens, K., Davis, K., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10637553

The STEP-UP Yet studies show only one third of women with GDM and about half of women with HDP see a primary care provider within 6 months postpartum. Of those with GDM, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05852054

Supporting Transitions to Primary Care Among Under ... STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) ...

3. withpower.com withpower.com/trial/phase-3-hypertension-pregnancy-induced-5-2023-362dc

Postpartum Care Support for Gestational Diabetes and ... STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or ...

4. bmjmedicine.bmj.com bmjmedicine.bmj.com/content/3/1/e000588

randomised, single centred, blinded, controlled trial Results 84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001212

Opportunities in the Postpartum Period to Reduce ... One of the largest trials tested the comparative effectiveness of a health system–based, DPP-derived intervention on 12-month postpartum weight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11408819/

Clinical decision support systems for maternity care The use of Clinical Decision Support Systems (CDSS) is increasing throughout healthcare and may be able to improve safety and outcomes in maternity care.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2210778925000807

Implementation of a novel surveillance and clinical ... We analyzed the demographic data and outcomes for all patients in the CDS and pre-CDS groups (total population) and also for the subgroup of patients with pre- ...

8. reporter.nih.gov reporter.nih.gov/search/14EACF0B4B8AC6D57598B8961CAA4A01A2FFCEB861BF/project-details/10637553

Project Details - NIH RePORTER Yet studies show only one third of women with GDM and about half of women with HDP see a primary care provider within 6 months postpartum. Of those with GDM, ...

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum HBPM increases postpartum BP ascertainment (92% versus 44%), improves postpartum visit attendance (adjusted OR, 2.30 [95% CI, 1.05–5.07]), ...