Hypertension, Pregnancy Induced
Conditions
Keywords
Postpartum Hypertension, Blood pressure management, Preeclampsia, Hypertension, pregnancy induced
Brief summary
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
Interventions
OTHERHigh-touch blood pressure management
Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care
OTHERLow-touch blood pressure management
10 days of text-based home blood pressure monitoring
Sponsors
Jennifer Lewey, MD, MPH
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Delivery within 14 days * Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum * Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum * English or Spanish speaking (able to read/understand consent and instructions) * Has phone texting capabilities
Exclusion criteria
* Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia) * Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery) * Chronic kidney disease (stage 3 or higher) * Using ≥3 BP medications at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean diastolic blood pressure (DBP) | 12 months postpartum | Assessed by 24-hour ambulatory blood pressure monitor (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure outcome: Mean systolic blood pressure (SBP) | 12 months postpartum | Assessed by 24-hour ambulatory blood pressure monitor (ABPM) |
| Blood pressure outcome: Mean nocturnal DBP | 12 months postpartum | Assessed by ABPM |
| Blood pressure outcome: Mean nocturnal SBP | 12 months postpartum | Assessed by ABPM |
| Blood pressure outcome: Mean DBP | 12 months postpartum | Assessed by home blood pressure monitor and office measurement |
| Chronic Hypertension | 12 months postpartum | Defined as 24-hour mean systolic blood pressure greater than or equal to 12mmHg, mean diastolic blood pressure greater than or equal to 75mmHg as assessed by ABPM or taking BP medication |
| Echocardiogram Outcomes | 12 months postpartum | Patients will all undergo a routine transthoracic echocardiogram. Measurements include: Left ventricle (LV) mass index, Relative wall thickness, mean E/e' ratio, left atrial (LA) volume index, global longitudinal strain. |
| Patient Reported Outcome - Patient Activation Measure | Post-randomization to 1 year postpartum | Patient Activation Measure (PAM) is a 10 survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. Scored on a scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation. Survey will be completed at 3 timepoints: at randomization, 6-10 weeks postpartum, and 12 months postpartum |
| Patient Reported Outcome - Perceived Stress | Post-randomization to 1 year postpartum | Scores from the validated Perceived Stress Scale (PSS-10) will be calculated using standard scoring criteria for each of the 10 items. Higher scores are correlated with more perceived stress. Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum. |
| Patient Reported Outcome - Self-Efficacy | Post randomization to 1 year postpartum | New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties. Using a 5-point rating scale where 1=strongly disagree and 5=strongly agree, scores are calculated by taking the average of their ratings. Survey to be completed at randomization, at 6-10 weeks postpartum, and at 1 year postpartum. |
| Implementation Outcome: Acceptability of Intervention | From 6 weeks postpartum through 1 year postpartum | Patients will be asked questions to assess the acceptability of the intervention. The questions will be scored on a Likert response scales from 1 to 5. Higher scores represent higher acceptability. Asked at two time points, 6 weeks and 12 months postpartum. |
Countries
United States
Contacts
CONTACTJennifer Lewey, MD, MPH
CONTACTAlexis Giron, M.S
PRINCIPAL_INVESTIGATORJennifer Lewey, MD, MPH
University of Pennsylvania
Outcome results
None listed