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Completed

NCT Number: NCT03613714

Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

At-home Blood Pressure Monitoring

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.

Other names: Digital Blood Pressure monitoring cuff

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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