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Clinical Trials/NCT03185455
NCT03185455
Completed
Not Applicable

Remote Surveillance of Postpartum Hypertension

University of Pennsylvania1 site in 1 country206 target enrollmentAugust 22, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension in Pregnancy
Sponsor
University of Pennsylvania
Enrollment
206
Locations
1
Primary Endpoint
Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP) surveillance to detect persistent hypertension. Various barriers result in only 30% attendance at postpartum BP visits. A more effective strategy is needed. Women with hypertension of pregnancy will be randomized to either text-based monitoring or office visits. Those randomized to the intervention will receive a BP cuff and text in their BP to an automated, clinician derived, HIPAA compliant text-based algorithm.

Detailed Description

Hypertension is a leading cause of maternal morbidity, mortality and obstetrical readmissions. Peak blood pressure usually occurs 3-6 days postpartum, and is typically unaccompanied by warning symptoms. Although there is a clear need for effective and reliable blood pressure surveillance after delivery, there are significant obstacles to in-person visits in the immediate postpartum period, including sleep deprivation, newborn care, and transportation needs. These barriers have proven real as we observed only 30-50% attendance to office blood pressure visits following delivery. This proposal will investigate whether text-based communication between patients and providers is an effective alternative method for monitoring postpartum hypertension in at risk women. Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.

Registry
clinicaltrials.gov
Start Date
August 22, 2016
End Date
January 23, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women with chronic hypertension, gestational hypertension, or preeclampsia who deliver at the Hospital of the University of Pennsylvania will be eligible to participate. All patients must be \> 18 years old, able to speak and read English, have a hypertension diagnosis, and have access to a cell phone with unlimited text message capabilities.

Exclusion Criteria

  • Women without access to a cell phone with unlimited text message capabilities will be excluded from the study in order to eliminate barriers to participate in remote surveillance. However, we will track the number of women not eligible for this reason in order to understand generalizability in an urban population.

Outcomes

Primary Outcomes

Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge

Time Frame: 10 days postdischarge

the percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.

Secondary Outcomes

  • Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum(2 weeks postpartum)
  • Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum(2 weeks postpartum)
  • Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum(2 weeks postpartum)
  • Patient Satisfaction(2 weeks postpartum)

Study Sites (1)

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