Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy

NCT03613714 | Completed

• 1 other identifier: 18-0995
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2-5 Days Post Hospital Discharge

Secondary Outcomes (5)

• Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery

  2 weeks from delivery

• Percentage of participants readmitted within 2 weeks of delivery

  2 weeks of delivery

• Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery

  2 weeks after delivery

• Percentage of participants with severe hypertension who present to OB triage or Emergency Department for recommended same-day evaluation

  Within 24 hours after BP evaluation

• Percentage of attendance to recommended 4-to-6-week postpartum visit

  Up to 6 weeks postpartum

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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.

Interventions

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.

Also known as: Digital Blood Pressure monitoring cuff

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Diagnosis of a hypertensive disorder of pregnancy (HDP)
• Chronic hypertension requiring medications

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Angelica Glover, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)