Postpartum Care Support for Gestational Diabetes and Hypertension

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Stacy Bailey, PhD MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Northwestern University

Disqualifiers: Diabetes, Hypertension, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{1 10 11 12 13}

Research Team

Stacy Bailey, PhD MPH

Principal Investigator

Northwestern University

Eligibility Criteria

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

I am 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

• OB Provider Clinical Decision Support (CDS) (Behavioral Intervention)
• Patient Education (OB Visit) (Behavioral Intervention)
• Patient Education (Primary Care Visit) (Behavioral Intervention)
• Patient Outreach (Behavioral Intervention)
• Primary Care Provider Clinical Decision Support (CDS) (Behavioral Intervention)
• Text messaging (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

Cook County Health

Collaborator

Trials

47

Recruited

16,800+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of preconception counseling on pregnancy outcomes. The experience of the Maine Diabetes in Pregnancy Program. [2019]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Source of Prenatal Care and Nonreceipt of Postpartum Health Care in the United States. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Obstetric patient safety: an overview. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Patient education: bridging the gap between inpatient and ambulatory care. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Obstetrician-Gynecologist Views of Pregnancy-Related Medication Safety. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Improving Postpartum and Long-Term Health After an Adverse Pregnancy Outcome: Examining Interventions From a Health Equity Perspective. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Postpartum care of women with gestational diabetes: survey of healthcare professionals. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Obstetricians seldom provide postpartum diabetes screening for women with gestational diabetes. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Patient counseling increases postpartum follow-up in women with gestational diabetes mellitus. [2021]