- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613714
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention Group
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.
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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.
Other Names:
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No Intervention: Usual Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants who undergo a BP evaluation by clinic staff at 2-5 days post-discharge
Time Frame: 2-5 Days Post Hospital Discharge
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BP evaluation will be counted if performed by clinic staff via telephone or in person if documented in the medical record.
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2-5 Days Post Hospital Discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery
Time Frame: 2 weeks from delivery
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2 weeks from delivery
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Percentage of participants readmitted within 2 weeks of delivery
Time Frame: 2 weeks of delivery
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Readmission, regardless of indication, within 2 weeks of delivery
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2 weeks of delivery
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Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery
Time Frame: 2 weeks after delivery
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2 weeks after delivery
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Percentage of participants with severe hypertension who present to OB triage or Emergency Department for recommended same-day evaluation
Time Frame: Within 24 hours after BP evaluation
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Includes those diagnosed with severe hypertension in the office or through phone follow-up
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Within 24 hours after BP evaluation
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Percentage of attendance to recommended 4-to-6-week postpartum visit
Time Frame: Up to 6 weeks postpartum
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Up to 6 weeks postpartum
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Collaborators and Investigators
Investigators
- Principal Investigator: Angelica Glover, MD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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