RECRUITING

Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications. The investigators will accomplish this by comparing the effectiveness of two multi-component multi-level healthcare delivery models focused on early detection and control of postpartum hypertension and the social and mental health factors known to impact maternal outcomes, with the current standard of care and with each other.

Official Title

Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension

Quick Facts

Study Start:2023-06-12

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05884190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify) * Postpartum * English or Spanish speaking * Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate) * Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured * Must living in one of the three states involved in this study (Connecticut, Massachusetts, New York) and preferably within the geographical area of each of the hospitals	* Multifetal pregnancy (since are they at increased risk for key outcomes) * Gestational age \<24 weeks; * Known major fetal anomaly in current pregnancy or stillbirth * Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes * Active suicidal ideation with intent and plan * Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder) * Plans to move out of the state within 6 months * Incapable of consent * Severe medical complications that don't allow a mother to do the study effectively (for example, active treatment for cancer, dialysis etc. ) * Physician or provider refusal * Patient refusal * Incarcerated or institutionalized * Stillbirth

Inclusion Criteria

Exclusion Criteria

* Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify)
* Postpartum
* English or Spanish speaking
* Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate)
* Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured
* Must living in one of the three states involved in this study (Connecticut, Massachusetts, New York) and preferably within the geographical area of each of the hospitals

* Multifetal pregnancy (since are they at increased risk for key outcomes)
* Gestational age \<24 weeks;
* Known major fetal anomaly in current pregnancy or stillbirth
* Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes
* Active suicidal ideation with intent and plan
* Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)
* Plans to move out of the state within 6 months
* Incapable of consent
* Severe medical complications that don't allow a mother to do the study effectively (for example, active treatment for cancer, dialysis etc. )
* Physician or provider refusal
* Patient refusal
* Incarcerated or institutionalized
* Stillbirth

Contacts and Locations

Study Contact

Rafael Pérez-Escamilla, PhD

CONTACT

8608052502

rafael.perez-escamilla@yale.edu

Principal Investigator

Rafael Pérez-Escamilla, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06520

United States

University of Massachusetts Memorial Health

Worcester, Massachusetts, 01655

United States

Oishei Children's Hospital University at Buffalo

Buffalo, New York, 14203

United States

Collaborators and Investigators

Sponsor: Yale University

Rafael Pérez-Escamilla, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12

Study Completion Date2027-10

Study Record Updates

Study Start Date2023-06-12

Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

Postpartum Hypertension