Enhanced Postpartum Care System for Maternal Death

Phase-Based Progress Estimates

Effectiveness

Safety

Grady Memorial Hospital, Atlanta, GA

Maternal Death+1 More

Enhanced Postpartum Care System - Behavioral

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Eligibility

Any Age

Female

What conditions do you have?

Select

Eligibility

Any Age

Female

What conditions do you have?

Select

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

Other trials for Maternal Death

Counseling about the Maternal Benefits of Breastfeeding

Eculizumab

Early Postpartum Contact

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

Safety Progress

1 of 3

Other trials for Maternal Death

Counseling about the Maternal Benefits of Breastfeeding

Eculizumab

Early Postpartum Contact

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

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 - 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.

References