Improving detection and management of postpartum hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: rafael.perez-escamilla@yale.edu
• Phone: 8608052502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.