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

320 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.

Research Team

Anne Dunlop, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

Have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)

Exclusion Criteria

I am unable to give consent for myself.

I am an infant.

Prisoners

Timeline

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

Treatment Details

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.

Participant Groups

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+