Enhanced Postpartum Care for Maternal Health

Overseen By Anne Dunlop, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Inability to consent, Infants, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve postpartum care for women with health risks such as high blood pressure, diabetes, or obesity. Researchers are developing a new care system, the Enhanced Postpartum Care System, to help these women maintain health after childbirth. Participants will either receive this new care system or continue with standard care to determine which is more effective. Women who are pregnant, planning to deliver at Grady Memorial Hospital, and have conditions like chronic diabetes or pre-pregnancy obesity may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative postpartum care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this postpartum care system is safe for women with cardiovascular risk factors?

Research shows that postpartum care systems focusing on conditions like diabetes and high blood pressure can improve health for new mothers. Studies have found that regular check-ups after childbirth, which include monitoring blood pressure and providing lifestyle advice, are important. These check-ups help manage and lower the risk of high blood pressure problems after pregnancy.

Specific data on negative effects from improved postpartum care systems is lacking. However, the main goal is to support and monitor mothers' health, which is generally safe and helpful. These systems address known risks like gestational diabetes and obesity, which can impact health after giving birth. The aim is to promote long-term health and prevent problems.

Overall, the enhanced postpartum care system is well-received because it involves regular health checks and lifestyle tips. No evidence suggests major safety concerns with this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Postpartum Care System because it offers a comprehensive approach to maternal health challenges, such as chronic diabetes, hypertension, and obesity, that goes beyond the standard postpartum care. Unlike traditional treatment methods, which typically focus on medical management alone, this system aims to provide a more integrated support strategy, potentially including lifestyle interventions, personalized care plans, and continuous monitoring. This holistic approach could lead to better health outcomes by addressing both immediate postpartum needs and long-term health, making it a promising innovation in maternal care.

What evidence suggests that the Enhanced Postpartum Care System could be effective for women with cardiovascular risk factors for severe maternal morbidity?

Research has shown that better care after childbirth can greatly improve health for women with heart-related risks. For women who had gestational diabetes, studies found that 57.9% received follow-up glucose tests within three months, which is crucial for managing diabetes. Similarly, 97.9% of women with pregnancy-related high blood pressure underwent follow-up checks, helping to manage this condition and reduce risks. Addressing issues like high blood pressure and diabetes after pregnancy can lower long-term health risks and enhance overall well-being. In this trial, participants will be randomized to receive either the Enhanced Postpartum Care System or standard postpartum care. The Enhanced Postpartum Care System aims to meet these needs more effectively than standard care. ^{1 3 6 7 8}

Who Is on the Research Team?

Anne Dunlop, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking women who have had at least one prenatal visit at Grady Memorial Hospital in Atlanta, plan to deliver there, and are 20-34 weeks pregnant with conditions like chronic diabetes, hypertension, gestational diabetes, or hypertensive pregnancy disorders.

Inclusion Criteria

I have a history of diabetes, high blood pressure, or obesity before pregnancy noted in my medical records.

Intend to deliver at Grady Memorial Hospital

I am pregnant and between 20 to 34 weeks along.

Exclusion Criteria

I am unable to give consent for myself.

I am an infant.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Design

In-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care

4-6 weeks

Treatment

Implementation of a woman-centered, comprehensive postpartum care system for women with cardiovascular risk factors

12 weeks

Regular postpartum visits as per the enhanced care system

Follow-up

Participants are monitored for ongoing pregnancy complications, medication use, and healthcare engagement

14 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Postpartum Care System

Trial Overview The study aims to create and test a new postpartum care system for women with cardiovascular risks. It starts with interviews to identify barriers to care and uses this information to design the system. Then it compares the new system's effectiveness against standard care through a randomized trial.

How Is the Trial Designed?

Group I: Enhanced Postpartum Care System Experimental Treatment 1 Intervention

Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive enhanced postpartum care.

Group II: Standard of Care Active Control 1 Intervention

Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive standard postpartum care.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.15516

Hypertensive disorders of pregnancy and gestational ... We examined whether HDP or GDM were associated with a higher 10- and 30-year predicted risk of ASCVD measured 10–14 years after delivery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869461/

Improving postpartum and long-term health after an ... Gestational diabetes mellitus and hypertensive disorders in pregnancy are adverse pregnancy outcomes (APOs) that affect 15% of pregnancies in the United States.

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

Hypertension in Pregnancy and Postpartum Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4158990/

Postpartum Healthcare After Gestational Diabetes and ... By the 3-month study visit, 51 (57.9%) women with GDM had completed follow-up glucose testing; 93 (97.9%) with HDP had follow-up blood pressure testing; and 101 ...

5. nature.com nature.com/articles/s44294-025-00095-7

Advances in postpartum hypertension management Postpartum hypertension care clinic visits within 6–12 weeks postpartum should include a BP check, education about lifestyle changes, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9483536/

A global view of hypertensive disorders and diabetes ... These two maternal CMDs are related to substantial short-term and long-term adverse health outcomes for pregnant individuals and their offspring ...

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

Opportunities in the Postpartum Period to Reduce ... Obesity increases risk for APOs, including HDP, gestational diabetes, and pregnancy loss. Obesity also increases risk for future CVD after APOs.

8. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.100864

Hypertensive Disorders of Pregnancy: Innovative ... A single-center prospective study that screened >10,000 postpartum women detected a new diagnosis of postpartum hypertension in 8%, most ...