Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy

• ClinicalTrials.gov Identifier: NCT03613714
• Recruitment Status: Completed
• First Posted: August 3, 2018
• Last Update Posted: March 13, 2020
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Hypertension in Pregnancy; Hypertension, Pregnancy-Induced; Postpartum Preeclampsia; Blood Pressure Disorders	Other: At-home Blood Pressure Monitoring	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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.	Other: At-home Blood Pressure Monitoring; 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 Name: Digital Blood Pressure monitoring cuff
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   BP evaluation will be counted if performed by clinic staff via telephone or in person if documented in the medical record.

Secondary Outcome Measures :

1. Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery [ Time Frame: 2 weeks from delivery ]
2. Percentage of participants readmitted within 2 weeks of delivery [ Time Frame: 2 weeks of delivery ]
   Readmission, regardless of indication, within 2 weeks of delivery
3. Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery [ Time Frame: 2 weeks after delivery ]
4. 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 ]
   Includes those diagnosed with severe hypertension in the office or through phone follow-up
5. Percentage of attendance to recommended 4-to-6-week postpartum visit [ Time Frame: Up to 6 weeks postpartum ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Angelica Glover, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03613714
• Other Study ID Numbers: 18-0995
• First Posted: August 3, 2018
• Last Update Posted: March 13, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual data that supports the results will be shared
• Time Frame: Beginning 9 to 36 months following publication
• 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.

• 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

Additional relevant MeSH terms:

Toxemia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Infections