Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
Primary Purpose
Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Postpartum Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
At-home Blood Pressure Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Age 18-60 years
- Diagnosis of a hypertensive disorder of pregnancy (HDP)
- Chronic hypertension requiring medications
Exclusion Criteria:
- Less than 18 years or older than 60 years
- No access to cellular telephone
- Chronic hypertension not on medications during pregnancy or postpartum
- No diagnosis of HDP
- Upper arm circumference < 9 inches or > 17 inches
- Incarcerated mother
- The woman requires a 1-week postpartum in-office visit for other medical reason unrelated to the diagnosis of hypertensive disorder of pregnancy
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention Group
Usual Care
Arm Description
At-home blood pressure monitoring at 2-5 days post-discharge from the hospital using a digital blood pressure cuff. Participants will receive text message reminders to check blood pressure. Contacted by clinic staff to review blood pressure log.
Blood pressure monitoring assessment will be done at 2-5 days post-discharge in the office. Participants will be given high blood pressure information hand-outs and instructed to follow-up in obstetric clinic for blood pressure check within 5 days after discharge from the hospital.
Outcomes
Primary Outcome Measures
Percentage of participants who undergo a BP evaluation by clinic staff at 2-5 days post-discharge
BP evaluation will be counted if performed by clinic staff via telephone or in person if documented in the medical record.
Secondary Outcome Measures
Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery
Percentage of participants readmitted within 2 weeks of delivery
Readmission, regardless of indication, within 2 weeks of delivery
Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery
Percentage of participants with severe hypertension who present to OB triage or Emergency Department for recommended same-day evaluation
Includes those diagnosed with severe hypertension in the office or through phone follow-up
Percentage of attendance to recommended 4-to-6-week postpartum visit
Full Information
NCT ID
NCT03613714
First Posted
July 25, 2018
Last Updated
March 12, 2020
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT03613714
Brief Title
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
Official Title
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertensive disorders of pregnancy (HDP) affect up to 10% of mother-infant dyads and account for 7.4% of cases of maternal mortality in the United States. Prompt recognition and treatment of hypertension remain one of the key features of management of mothers affected by these conditions. Up to 41% of severe morbidity and mortality from HDP occurs after 48 hours postpartum, as postpartum blood pressures tend to peak 3-6 days after birth. For these reasons, early postpartum follow-up is recommended for women diagnosed with HDP, in the form of blood pressure (BP) evaluation by a health care provider at 7-10 days postpartum (2-5 days post-discharge from maternity care). However, barriers to follow-up limit mothers' ability to adhere to this recommendation. A potential alternative to in-office evaluation is at-home BP monitoring. At-home BP monitoring is a novel, affordable method to empower, educate, and engage postpartum women affected by HDP. Within the obstetric (OB) population, pilot studies have demonstrated the feasibility and acceptability of remote BP monitoring. Hence, the purpose of this randomized trial is to empower postpartum women affected by HDP and cared for at North Carolina Women's Hospital to perform at-home BP monitoring with the aid of digital technology.
Detailed Description
Hypertensive disorders of pregnancy (HDP) affect up to 10% of mother-infant dyads and account for 7.4% of cases of maternal mortality in the United States. Prompt recognition and treatment of hypertension remain one of the key features of management of mothers affected by these conditions. Improving recognition and treatment is of particular importance given that maternal mortality rates continue to rise in the United States. Moreover, mothers affected by HDP are at increased risk of long-term morbidity, such as cardiovascular disease, atherosclerosis, and persistent hypertension outside of pregnancy. Therefore, it is critical to recognize hypertension throughout maternity care, including in the postpartum period.
The postpartum period is a time of major challenges for the new mother and considerable physiologic changes that place the new mother at increased risk of adverse events. For a postpartum woman with a diagnosis of a HDP, the risk of complications extends beyond discharge from maternity care: up to 41% of severe morbidity and mortality from HDP occurs after 48 hours postpartum, as postpartum blood pressures tend to peak 3-6 days after birth. For these reasons, the American College of Obstetricians and Gynecologists (ACOG) and the National Partnership for Maternal Safety recommend early postpartum follow-up for women diagnosed with HDP, in the form of blood pressure (BP) evaluation by a health care provider at 7-10 days postpartum. However, barriers to follow-up, including childcare arrangements, transportation access, and recovery from delivery, limit mothers' ability to adhere to this recommended in-office follow-up. Indeed, attendance at postpartum follow-up visits is poor and reflects significant disparities.
A potential alternative to in-office evaluation is at-home blood pressure (BP) monitoring. At-home BP monitoring is a novel, affordable method to empower, educate, and engage postpartum women affected by HDP. This approach is not in widespread use in the US, despite the American Heart Association indicating that home BP monitoring is recommended for all people with high blood pressure. Within the obstetric population, pilot studies have demonstrated the feasibility and acceptability of remote BP monitoring. However, a randomized trial of postpartum at-home BP monitoring compared with office-based follow-up is lacking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Blood Pressure Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
At-home blood pressure monitoring at 2-5 days post-discharge from the hospital using a digital blood pressure cuff. Participants will receive text message reminders to check blood pressure. Contacted by clinic staff to review blood pressure log.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Blood pressure monitoring assessment will be done at 2-5 days post-discharge in the office. Participants will be given high blood pressure information hand-outs and instructed to follow-up in obstetric clinic for blood pressure check within 5 days after discharge from the hospital.
Intervention Type
Other
Intervention Name(s)
At-home Blood Pressure Monitoring
Other Intervention Name(s)
Digital Blood Pressure monitoring cuff
Intervention Description
Participants will use over-the-counter digital monitor to measure blood pressure and pulse rate at home. Automatically averages the last 3 readings taken over 10 minutes.
Primary Outcome Measure Information:
Title
Percentage of participants who undergo a BP evaluation by clinic staff at 2-5 days post-discharge
Description
BP evaluation will be counted if performed by clinic staff via telephone or in person if documented in the medical record.
Time Frame
2-5 Days Post Hospital Discharge
Secondary Outcome Measure Information:
Title
Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery
Time Frame
2 weeks from delivery
Title
Percentage of participants readmitted within 2 weeks of delivery
Description
Readmission, regardless of indication, within 2 weeks of delivery
Time Frame
2 weeks of delivery
Title
Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery
Time Frame
2 weeks after delivery
Title
Percentage of participants with severe hypertension who present to OB triage or Emergency Department for recommended same-day evaluation
Description
Includes those diagnosed with severe hypertension in the office or through phone follow-up
Time Frame
Within 24 hours after BP evaluation
Title
Percentage of attendance to recommended 4-to-6-week postpartum visit
Time Frame
Up to 6 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-60 years
Diagnosis of a hypertensive disorder of pregnancy (HDP)
Chronic hypertension requiring medications
Exclusion Criteria:
Less than 18 years or older than 60 years
No access to cellular telephone
Chronic hypertension not on medications during pregnancy or postpartum
No diagnosis of HDP
Upper arm circumference < 9 inches or > 17 inches
Incarcerated mother
The woman requires a 1-week postpartum in-office visit for other medical reason unrelated to the diagnosis of hypertensive disorder of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Glover, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual data that supports the results will be shared
IPD Sharing Time Frame
Beginning 9 to 36 months following publication
IPD Sharing Access Criteria
The investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and execute a data use/sharing agreement with UNC.
Learn more about this trial
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
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