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NCT Number: NCT07599579

Mobile Health Program for Post-Preeclampsia Hypertension

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

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Key information

Conditions

Hypertension (HTN) Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Hypertensive Disorders of Pregnancy (HDP) Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location contact

Amy Travis

CONTACT

[email protected]

4126413295

Malamo Countouris, MD, MS

PRINCIPAL_INVESTIGATOR

Samantha Bryan

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
  • Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).

Exclusion criteria

  • Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
  • Males will also be excluded from this study as it focuses on pregnancy related conditions.
  • Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.

Treatment and study plan

Coaching application

Behavioral

A digital application for providing education and support for home-based blood pressure monitoring.

Home-based blood pressure monitoring

Behavioral

Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

WebMD

Other

Smartphone-based application for health education and/or monitoring.

Primary outcomes

  1. Change in systolic blood pressure from baseline to 3 months

    Time frame: Baseline, 3 Months

    Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.

Secondary outcomes

  1. Change in diastolic BP and mean arterial pressure from baseline to 3 months

    Time frame: Baseline, 3 months

    Change in diastolic BP and mean arterial pressure from baseline to 3 months

  2. Adherence to antihypertensive medications at 3 months and 6 months

    Time frame: Baseline, 6 months

    Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.

  3. Proportion with BP controlled <130/80 mmHg at 3 months and 6 months

    Time frame: Baseline, 3 months, 6 months

  4. Adherence to home blood pressure monitoring

    Time frame: Baseline, 3 months

    Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.

  5. Feasibility of study measured using enrollment, survey completion, and retention of participants

    Time frame: Baseline, 3 Month, 6 Month

    Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study

  6. Durable change in systolic blood pressure measures at 6 months

    Time frame: Baseline, 6 months

    Durable change in SBP measures at 6 months between intervention and usual care arms

  7. Durable change in diastolic BP measures at 6 months

    Time frame: Baseline, 6 months

    Durable change in DBP measures at 6 months between intervention and usual care arms

  8. Blood pressure at 3 months

    Time frame: Baseline, 3 months

    Systolic, diastolic, and mean arterial blood pressure at 3 months

  9. Blood pressure at 6 months

    Time frame: Baseline, 6 months

    Systolic, diastolic, and mean arterial blood pressure at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Travis

CONTACT

[email protected]

4126413295

Samantha Bryan

CONTACT

[email protected]

412-641-1363

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • McKamish Family Foundation

Registry information

Official study title

Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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