Postpartum HypertensionNCT05884190
Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
A study testing Remote Medical Model (RMM), Community Health Model (CHM) and SoC in people with Postpartum Hypertension, run by Yale University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hypertension
- What is being tested?
- Remote Medical Model (RMM), Community Health Model (CHM) and SoC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,030 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jun 2023to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Oishei Children's Hospital University at Buffalo
Buffalo, New York, 14203
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
Rafael Pérez-Escamilla, PhD
- Recruiting
University of Massachusetts Memorial Health
Worcester, Massachusetts, 01655
About this study
Official title: Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
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.
Read the detailed description
This study will compare two interventions with the standard of care. Given that this is a stepped-wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it.
General Design Description Overall study design. This project spans three states (Connecticut, Massachusetts, New York) and includes three hospitals (Yale New Haven Hospital, UMass Worcester, and Oishei in Buffalo, New York). This is a multisite intervention study that follows a sequential stepped-wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms.
Yale will serve as the coordinating center and facilitate as well as oversee the planning and implementation activities across sites to ensure standardization. All study staff at all centers will undergo training sessions in blood pressure measurement and management following a standardized protocol as well as mental health screening and management and refresher training sessions, as needed, including any remedial training in specific areas targeted by quality control monitoring for a specific site. Yale New Haven Hospital will provide the appropriate assistance across clinical sites. This may include site visits, to ensure that the study enrollment and treatment follows proper study procedures.
Community Advisory Boards (CABs) will be formed at each of the project sites to integrate community perspectives into project activities and ensure community engagement in the decision-making process throughout the duration of the project. The Yale Griffin Prevention Research Center (PRC) and Cicatelli Associates, Inc. (CAI) will be deeply engaged advising on the establishment of the CABs across sites. Twice a year, the three CABs will convene virtually to receive an update about the overall project progress and share ideas about strengthening study design and implementation to ensure it reflects overall community needs and best interests. We will compensate members for their participation and transportation plus provide refreshments for in-person meetings. During in-person meetings of the individual site CABs, current COVID protocols recommended by the Centers for Disease Control will be followed to ensure meetings are safe and participants protected.
This study will compare two interventions with the standard of care. Given that this is a stepped-wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it.
Participants in the first intervention RMM will be provided with an Omron blood pressure cuff and blood pressure data will be recorded. Participants will be contacted within 72 hours following discharge. Follow-up telehealth visits will occur at least 1 time per week for the first 6 weeks and up to 12 weeks as needed. There may be a need for more visits for those with high blood pressure or elevated scores on validated mental health screeners, therefore advanced practice professionals (APPs) will coordinate with the individual site team Co-Is to address and arrange for additional follow-up visits with the appropriate providers as indicated.
In addition to the RMM described above, the second intervention, the community health model (CHM), includes the incorporation of research community health workers(CHW)/doulas who will be identified at each site. The CHWs/doulas will receive extensive training to be able to provide postpartum hypertension support and how to engage individuals in mental health services using a strengths-based trauma-informed approach. CHWs/doulas will be available to the families during the first 6 weeks (at least 1x per week) and then every other month or as needed. A hybrid approach will be used with CHWs/doulas visiting participants in-person and virtual based on the participant's needs and preferences.
All participants will complete assessments and a blood pressure at intake along with telephone follow-up assessments at 6 weeks postpartum, 3 months and 6 months postpartum including a blood pressure check and mental health screen with EPDS and other study surveys at each time point. Electronic medical record data will be collected.
- Conditions
- Postpartum Hypertension
- Being tested
- Remote Medical Model (RMM), Community Health Model (CHM), SoC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Medical Model (RMM)Other
Remote home blood pressure (BP) monitoring once a day for the first 7 days and then at least weekly or more frequently as per a standardized blood pressure protocol up to six weeks and weekly virtual visits for 6 weeks and up to 12 weeks as needed by a physician extender (e.g. Nurse Practitioner, Pharmacist, etc.), and screening for social determinants of health and anxiety/ depression with referral for services if positive
Community Health Model (CHM)Other
Utilization of community health workers trained in a strength-based trauma informed dyadic evidence-based approach.
SoCOther
SoC for Postpartum Hypertension
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | Active comparator | Standard of Care for Postpartum Hypertension Receives: Other: SoC |
| Remote Medical Model (RMM) | Experimental | Includes SoC plus RMM Receives: Other: Remote Medical Model (RMM); Other: SoC |
| Community Health Model (CHM) | Experimental | Includes SoC, RMM plus CHM Receives: Other: Remote Medical Model (RMM); Other: Community Health Model (CHM); Other: SoC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks. A reduction in SBP indicates an improvement in postpartum hypertension.
Measured: 6 weeks
Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS).
EPDS is a 10-item validated scale that measures depressive symptoms and is designed for use with pregnant and postpartum women. Scoring: None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A reduction in depression severity at 3 months postpartum indicates a positive outcome.
Measured: 3 months
Secondary outcomes (1)
Participant engagement
Engagement with a health care provider by 6 weeks will be assessed via self-report (collected via interview) and electronic medical records (indicator will be whether the participant was engaged in care at least once in the 6 weeks postpartum).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start12 Jun 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HypertensionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will include adult postpartum women at least 18 yrs old that are at-risk for hypertension and/or poor mental health outcomes. This is a multi-site intervention study that follows a sequential stepped-wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms.
- Masking
- None (open label)
- Enrolment
- 6,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Rafael Pérez-Escamilla, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884190
- Sponsor's protocol ID
- 2000033779
- Other IDs
- MMM-2021C2-23671
- Status last verified
- Nov 2026
- First submitted
- 22 May 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
- ClinicalTrials.gov ID
- NCT05884190
- Acronym / sponsor ID
- 2000033779
- Conditions
- Postpartum Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,030 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will compare two interventions with the standard of care. Given that this is a stepped-wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it.
General Design Description Overall study design. This project spans three states (Connecticut, Massachusetts, New York) and includes three hospitals (Yale New Haven Hospital, UMass Worcester, and Oishei in Buffalo, New York). This is a multisite intervention study that follows a sequential stepped-wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms.
Yale will serve as the coordinating center and facilitate as well as oversee the planning and implementation activities across sites to ensure standardization. All study staff at all centers will undergo training sessions in blood pressure measurement and management following a standardized protocol as well as mental health screening and management and refresher training sessions, as needed, including any remedial training in specific areas targeted by quality control monitoring for a specific site. Yale New Haven Hospital will provide the appropriate assistance across clinical sites. This may include site visits, to ensure that the study enrollment and treatment follows proper study procedures.
Community Advisory Boards (CABs) will be formed at each of the project sites to integrate community perspectives into project activities and ensure community engagement in the decision-making process throughout the duration of the project. The Yale Griffin Prevention Research Center (PRC) and Cicatelli Associates, Inc. (CAI) will be deeply engaged advising on the establishment of the CABs across sites. Twice a year, the three CABs will convene virtually to receive an update about the overall project progress and share ideas about strengthening study design and implementation to ensure it reflects overall community needs and best interests. We will compensate members for their participation and transportation plus provide refreshments for in-person meetings. During in-person meetings of the individual site CABs, current COVID protocols recommended by the Centers for Disease Control will be followed to ensure meetings are safe and participants protected.
This study will compare two interventions with the standard of care. Given that this is a stepped-wedge design, all sites will begin with recruitment for the standard of care. All study participants will be identified, recruited and enrolled during their postpartum hospital stay (i.e. prior to discharge) by research study staff. Once study participants are enrolled, they will receive a Omron blood pressure (BP) cuff and will be instructed on how to use it.
Participants in the first intervention RMM will be provided with an Omron blood pressure cuff and blood pressure data will be recorded. Participants will be contacted within 72 hours following discharge. Follow-up telehealth visits will occur at least 1 time per week for the first 6 weeks and up to 12 weeks as needed. There may be a need for more visits for those with high blood pressure or elevated scores on validated mental health screeners, therefore advanced practice professionals (APPs) will coordinate with the individual site team Co-Is to address and arrange for additional follow-up visits with the appropriate providers as indicated.
In addition to the RMM described above, the second intervention, the community health model (CHM), includes the incorporation of research community health workers(CHW)/doulas who will be identified at each site. The CHWs/doulas will receive extensive training to be able to provide postpartum hypertension support and how to engage individuals in mental health services using a strengths-based trauma-informed approach. CHWs/doulas will be available to the families during the first 6 weeks (at least 1x per week) and then every other month or as needed. A hybrid approach will be used with CHWs/doulas visiting participants in-person and virtual based on the participant's needs and preferences.
All participants will complete assessments and a blood pressure at intake along with telephone follow-up assessments at 6 weeks postpartum, 3 months and 6 months postpartum including a blood pressure check and mental health screen with EPDS and other study surveys at each time point. Electronic medical record data will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study population will include adult postpartum women at least 18 yrs old that are at-risk for hypertension and/or poor mental health outcomes. This is a multi-site intervention study that follows a sequential stepped-wedge design with the 3 hospitals randomized to their start time for the first arm followed by the second and third arms.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Active comparator | Other: SoCStandard of Care for Postpartum Hypertension |
| Remote Medical Model (RMM) | Experimental | Other: Remote Medical Model (RMM), Other: SoCIncludes SoC plus RMM |
| Community Health Model (CHM) | Experimental | Other: Remote Medical Model (RMM), Other: Community Health Model (CHM), Other: SoCIncludes SoC, RMM plus CHM |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Medical Model (RMM)Remote home blood pressure (BP) monitoring once a day for the first 7 days and then at least weekly or more frequently as per a standardized blood pressure protocol up to six weeks and weekly virtual visits for 6 weeks and up to 12 weeks as needed by a physician extender (e.g. Nurse Practitioner, Pharmacist, etc.), and screening for social determinants of health and anxiety/ depression with referral for services if positive | Other | Community Health Model (CHM), Remote Medical Model (RMM) |
| Community Health Model (CHM)Utilization of community health workers trained in a strength-based trauma informed dyadic evidence-based approach. | Other | Community Health Model (CHM) |
| SoCSoC for Postpartum Hypertension | Other | Community Health Model (CHM), Remote Medical Model (RMM), Standard of Care (SoC) |
Primary outcome
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks
Time frame: 6 weeks
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks. A reduction in SBP indicates an improvement in postpartum hypertension.
Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS).
Time frame: 3 months
EPDS is a 10-item validated scale that measures depressive symptoms and is designed for use with pregnant and postpartum women. Scoring: None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A reduction in depression severity at 3 months postpartum indicates a positive outcome.
1 secondary outcome
Participant engagement
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Pérez-Escamilla, PhD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Medical Model (RMM), Community Health Model (CHM) and SoC in people with Postpartum Hypertension, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Pérez-Escamilla, PhD (8608052502, rafael.perez-escamilla@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.