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New treatment option for Postpartum Hypertension
Official title Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
ClinicalTrials.gov ID: NCT05884190
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Active suicidal ideation with intent and plan
- Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)
See the full eligibility 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 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Worcester, Massachusetts, United States
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Worcester, Massachusetts, United States; Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.