Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy

NCT ID: NCT03613714

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Hypertension in Pregnancy; Hypertension, Pregnancy-Induced; Postpartum Preeclampsia; Blood Pressure Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

At-home Blood Pressure Monitoring

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Digital Blood Pressure monitoring cuff

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angelica Glover, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

18-0995

Identifier Type: -

Identifier Source: org_study_id