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Enhanced Postpartum Care for Maternal Health
N/A
Waitlist Available
Led By Anne Dunlop, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Speak English or Spanish
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after delivery, 14 months after delivery
Awards & highlights
Study Summary
This trial will test a new system of postpartum care for women with cardiovascular risks factors for severe maternal morbidity. The system will be designed to help women overcome barriers to care engagement and will be compared to standard care.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves an enhanced postpartum care system rather than medication, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts from different levels of healthcare engagement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants attending the postpartum visit
Secondary outcome measures
Change in Edinburgh Postnatal Depression Scale (EPDS) Score
Change in Number of Participants Readmitted to the Hospital
Change in Number of Participants Using Contraception
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Postpartum Care SystemExperimental Treatment1 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 CareActive Control1 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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,253 Total Patients Enrolled
1 Trials studying Maternal Death
300 Patients Enrolled for Maternal Death
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,334 Total Patients Enrolled
1 Trials studying Maternal Death
1,538 Patients Enrolled for Maternal Death
Anne Dunlop, MD, MPHPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.I have a history of diabetes, high blood pressure, or obesity before pregnancy noted in my medical records.I am unable to give consent for myself.I am an infant.I am pregnant and between 20 to 34 weeks along.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Postpartum Care System
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide an estimate of the participant count in this research project?
"Right. According to clinicaltrials.gov, this scientific study is still in the process of enrolling participants since it was initially posted on August 8th 2022 and last modified on the 9th of that month. The trial requires 320 patients from one medical centre."
Answered by AI
Is this research initiative currently accepting new participants?
"Data from clinicaltrials.gov validates this trial is currently recruiting patients. The original posting was on August 8th, 2022 and the latest update was recorded as of 9th August 2022."
Answered by AI
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