Enhanced Postpartum Care System for Maternal Death

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Grady Memorial Hospital, Atlanta, GA
Maternal Death+1 More
Enhanced Postpartum Care System - Behavioral
Eligibility
Any Age
Female
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Study Summary

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, 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.

Eligible Conditions

  • Maternal Death
  • Maternal Morbidity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 12 weeks after delivery, 14 months after delivery

12 weeks after delivery
Number of Participants Receiving Postpartum Diabetes Screening
Number of Participants Receiving Postpartum Hypertension Screening
Number of participants attending the postpartum visit
Perceived Risk of Severe Maternal Morbidity (SMM)
Satisfaction with Postpartum Care
Satisfaction with Provider at Postpartum Care Visit
Month 14
Change in Edinburgh Postnatal Depression Scale (EPDS) Score
Change in Number of Participants Readmitted to the Hospital
Change in Number of Participants Using Contraception
Change in Number of Participants Using Medication
Change in Number of Participants Using Primary Care
Change in Number of Participants Using Specialty Care
Change in Number of Participants with Ongoing Pregnancy Complications
Change in Perceived Risk of Cardiovascular Disease
14 months after delivery
Self-rated Health

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Enhanced Postpartum Care System
1 of 2
Active Control
Experimental Treatment

320 Total Participants · 2 Treatment Groups

Primary Treatment: Enhanced Postpartum Care System · No Placebo Group · N/A

Enhanced Postpartum Care System
Behavioral
Experimental Group · 1 Intervention: Enhanced Postpartum Care System · Intervention Types: Behavioral
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after delivery, 14 months after delivery

Trial Background

Prof. Denise Jamieson, Professor and Chair
Principal Investigator
Emory University
Closest Location: Grady Memorial Hospital · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2011First Recorded Clinical Trial
1 TrialsResearching Maternal Death
286 CompletedClinical Trials

Eligibility Criteria

Age Any Age · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or a hypertensive disorder of pregnancy documented in the EMR.
You have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA).
You must be fluent in English or Spanish.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.