Improving detection and management of postpartum hypertension

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

This study is testing two new ways to help new moms check and manage their blood pressure after giving birth to see if they work better than the usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6030 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Yale University (Academic / other)
• Locations: 3 sites (New Haven, Connecticut and 2 other locations)
• Trial ID: NCT05884190 on ClinicalTrials.gov

What this trial studies

This project aims to enhance clinical outcomes for postpartum women at risk of hypertension by implementing two innovative healthcare delivery models and comparing their effectiveness against the standard care. The study will recruit participants during their hospital stay after delivery and provide them with a blood pressure cuff for self-monitoring. It will utilize a stepped-wedge design across three hospitals in Connecticut, Massachusetts, and New York, ensuring standardized training for all staff involved in the study. The focus is on timely detection and management of hypertension, as well as addressing mental health and social factors that affect maternal health.

Who should consider this trial

Good fit: Ideal candidates include postpartum women who have delivered a singleton live birth, are English or Spanish speaking, and are either Medicaid recipients or uninsured, residing in Connecticut, Massachusetts, or New York.

Not a fit: Patients with multifetal pregnancies, gestational age less than 24 weeks, or those with active substance use or severe mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the health outcomes of postpartum women by ensuring timely detection and management of hypertension and related complications.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving maternal health outcomes through targeted interventions.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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

Births that result in the newborn being under the care of another person or institution other than the birthing individual (e.g. adoption, state involvement) will be evaluated on an individual basis to determine if that person should be included.

For participants without access to a phone, we will explore if there are options that will allow them to have access to a devise for the times when they need to communicate with the study team. If not, they will not be able to participate in the study since this study requires phone or telehealth communication with research staff and/or APPs, and CHWs depending on study phase.

Where this trial is running

New Haven, Connecticut and 2 other locations

• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
• University of Massachusetts Memorial Health — Worcester, Massachusetts, United States (Recruiting)
• Oishei Children's Hospital University at Buffalo — Buffalo, New York, United States (Recruiting)

Study contacts

• Principal investigator: Rafael Pérez-Escamilla, PhD — Yale University
• Study coordinator: Rafael Pérez-Escamilla, PhD

Conditions Postpartum Hypertension