Clinical trial NCT06096701: Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women
Official title: Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertensive Disorder
Keywords: Preeclampsia
Gestational hypertension
Eclampsia
Chronic hypertension
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Prisma Health-Midlands
First posted: 2023-10-24
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who will deliver at Prisma Health Richland.

Brief summary: Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden.

Detailed description: Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden.

Eligibility criteria: Inclusion Criteria:

* Pregnant individuals with hypertensive disorders
* Speak English
* At least 18 years old
* Medicaid coverage
* Between 20 weeks of pregnancy and 2 weeks postpartum
* Postpartum admission at Prisma Health Richland with hypertensive disorder within 2 weeks postpartum

Exclusion Criteria:

* Not planning to deliver at Prisma Health Richland
* Less than 20 weeks of pregnancy
* More than 2 weeks postpartum

Primary outcomes:
measure: Blood pressure ascertainment
timeFrame: First 6 weeks postpartum
Secondary outcomes:
measure: Percent of patients attending an in-person postpartum visit
timeFrame: First 8 weeks postpartum
measure: Percent of patients readmitted to the hospital through 12 months postpartum
timeFrame: 12 months postpartum
measure: Survey assessing patient's acceptability and satisfaction with the BP monitoring program
timeFrame: First 8 weeks postpartum
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prisma Health Richland
state: South Carolina
Study officials:
References: