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MH-Rx Study (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)

RecruitingNAAges 18 Years - 45 YearsFemaleTexas Southern University
NCT07842341 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled trial will evaluate whether adding Community Health Worker (CHW)/Social Worker (SW)-led support for non-medical health related needs (NMHRN) and clinician-led Medication Therapy Management (MTM) to remote blood pressure monitoring improves outcomes for pregnant women with chronic hypertension or gestational hypertension (i.e high blood pressure that was present before pregnancy or developed during pregnancy). All participants will monitor their blood pressure at home, use the TSU MH Rx app, and complete assessments related to social needs, depression, anxiety, pregnancy care experiences, and satisfaction. Only participants in the intervention group will receive targeted virtual social needs support and virtual regular MTM sessions focused on medications, self-care, adherence, and risk reduction. The study will assess blood pressure and maternal outcomes, feasi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female, pregnant ≤34 weeks * Pregnancy Status: Pregnant, up to 34 weeks of gestation. Able to provide medical confirmation of pregnancy * Age 18-45 * Diagnosis of chronic hypertension or Gestational Hypertension ( i.e: high blood pressure that was present before pregnancy or developed during pregnancy). * Currently taking ≥1 medication * Smartphone user * Able to speak and read English * Ability to participate in self-led surveys and perform remote blood pressure monitoring Exclusion Criteria: * Inability to Provide Legal Consent: Individuals who cannot legally consent to participate in the research study will be excluded. * Availability Constraints: Individuals who are unavailable or unable to commit to the required study sessions and self-led surveys throughout the duration of their pregnancy and the 14-week postpartum follow-up period. * Language Barrier: Individuals who do not speak and read English. * Inability or Unwillingness to Provide Required Information: Individuals who are unable or unwilling to provide reliable contact information (phone, email, or address for app/text-based study communications), basic medical history needed to verify eligibility, or medical confirmation of pregnancy and gestational age (e.g., discharge summary, progress note, MyChart note, or signed medical release).
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What it tests

  • Community Health Worker (CHW)/Social Worker (SW)-led non-medical health related needs (NMHRN) intervention + Clinician-Led Medication Therapy Management (MTM) with remote blood pressure monitoring
  • Active Comparator (Control group)
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Where

1 site
Texas Southern University Nabrit Science Building, 3100 Cleburne St.
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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