Self-Management of Hypertension in Postpartum women: A Randomized Controlled Feasibility Trial

BACKGROUND: Hypertensive disorders of pregnancy (HDP) affect 15% of pregnant individuals, are significant contributors to maternal morbidity and mortality in the US, and disproportionately impact Black individuals. Individuals with HDP have a 12-fold higher risk of chronic hypertension within one year postpartum. HDP is also associated with a 2-fold higher risk of later cardiovascular disease (CVD) and stroke in part through accelerated vascular aging. Improved blood pressure (BP) control early postpartum may prevent vascular remodeling and lower long-term hypertension risk. To date, there are no standardized management guidelines to guide BP control in the postpartum period.
OBJECTIVE: Understand the feasibility of a 12-week remote blood pressure monitoring program combined with self-management compared to usual care among postpartum individuals with hypertensive disorders of pregnancy.
STUDY DESIGN: We will conduct an unblinded pilot two-arm randomized, controlled feasibility trial, with an anticipated sample size of 50 participants. We will enroll racially and socioeconomically diverse postpartum women from Penn with a diagnosis of HDP and on BP medication at 10 days postpartum. Following completion of usual care (10-day BP texting program), participants will be randomized to text-based remote home BP monitoring with built-in self-management tool (intervention arm) or usual care for 26 weeks. Primary outcomes include completion rates and quality of life measures. Secondary outcomes include BP control and primary care follow-up. Qualitative interviews will be performed to assess intervention acceptability across patient groups.
IMPACT: Strategies that improve postpartum CVD risk factor management and reduce disparities in BP control have the potential to be incorporated into standard of care. This trial will generate important data to inform the design of a larger RCT powered to detect difference in BP control as part of a future grant application. This study will provide valuable training experience for Dr. Afari, a cardiology fellow, to advance her research career in women’s health cardiology and developing interventions that improve maternal outcomes in resource poor settings.