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Healthcare Models for Postpartum Hypertension
N/A
Recruiting
Led By Rafael Pérez-Escamilla, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial aims to improve postpartum health outcomes, including mental health, among at-risk women by increasing awareness and care of postpartum hypertension & mental health & cardiovascular issues. It will compare two healthcare delivery models to the current standard of care.
Who is the study for?
This trial is for postpartum women who had a single live birth, speak English or Spanish, are on Medicaid or uninsured, and live in Connecticut, Massachusetts, or New York. They must be able to consent and not have severe medical conditions that interfere with participation. Women planning to move out of state soon or using illicit drugs cannot join.Check my eligibility
What is being tested?
The study tests two healthcare delivery models aimed at early detection and management of postpartum hypertension against the standard care. One model uses remote monitoring (RMM), while the other involves community health approaches (CHM). The goal is to see which method improves clinical outcomes better.See study design
What are the potential side effects?
Since this trial focuses on healthcare delivery methods rather than medications, traditional side effects are not applicable. However, there may be indirect effects related to stress from participation or privacy concerns due to remote monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either uninsured or covered by Medicaid or its state equivalent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks
Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS).
Secondary outcome measures
Participant engagement
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Remote Medical Model (RMM)Experimental Treatment2 Interventions
Includes SoC plus RMM
Group II: Community Health Model (CHM)Experimental Treatment3 Interventions
Includes SoC, RMM plus CHM
Group III: Standard of Care (SoC)Active Control1 Intervention
Standard of Care for Postpartum Hypertension
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,732,531 Total Patients Enrolled
21 Trials studying Hypertension
9,942 Patients Enrolled for Hypertension
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,991,428 Total Patients Enrolled
15 Trials studying Hypertension
231,311 Patients Enrolled for Hypertension
Rafael Pérez-Escamilla, PhDPrincipal InvestigatorYale University
3 Previous Clinical Trials
564 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a serious mental illness like schizophrenia or schizoaffective disorder.You have recently given birth.I speak English or Spanish.I am either uninsured or covered by Medicaid or its state equivalent.My newborn is under someone else's care due to adoption or state involvement.You have given birth to one live baby (you may have had twins, but only one baby survived).You are currently thinking about hurting yourself and have a plan to do so.My doctor has advised against me joining this trial.I have chosen not to participate in the trial.I do not have severe medical issues like active cancer treatment or dialysis.I am unable to give consent by myself.You are less than 24 weeks pregnant.You are currently using illegal drugs like cocaine, heroin, or fentanyl.The loss of a baby before it is born.You are pregnant with more than one baby, which can increase the risk of certain outcomes.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SoC)
- Group 2: Remote Medical Model (RMM)
- Group 3: Community Health Model (CHM)
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.
Does this research project welcome new participants at this time?
"As indicated on clinicaltrials.gov, this particular study is not currently seeking patients; the trial was originally posted June 1st 2023 and amended May 22nd of that same year. However, there are 736 other medical trials actively in search for participants at present."
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