Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03613714
Other study ID # 18-0995
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2019

Study information

Verified date March 2020
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery 2 weeks from delivery
Secondary Percentage of participants readmitted within 2 weeks of delivery Readmission, regardless of indication, within 2 weeks of delivery 2 weeks of delivery
Secondary Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery 2 weeks after delivery
Secondary Percentage of participants with severe hypertension who present to OB triage or Emergency Department for recommended same-day evaluation Includes those diagnosed with severe hypertension in the office or through phone follow-up Within 24 hours after BP evaluation
Secondary Percentage of attendance to recommended 4-to-6-week postpartum visit Up to 6 weeks postpartum
See also
  Status Clinical Trial Phase
Completed NCT00974714 - L-arginine Effects on Chronic Hypertension in Pregnancy Phase 3
Terminated NCT03595982 - Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily? Phase 4
Completed NCT04486170 - Assessment of Postpartum Education to Improve Compliance N/A
Completed NCT03506724 - Response to Anti-hypertensives in Pregnant and Postpartum Patients Phase 4
Recruiting NCT04604535 - The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy N/A
Completed NCT00412230 - Insulin Resistance and Hypertensive Disorders in Pregnancy N/A
Active, not recruiting NCT05049616 - Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension Phase 4
Completed NCT04119232 - Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy N/A
Completed NCT04633551 - Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes N/A
Completed NCT05859282 - Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
Active, not recruiting NCT05543265 - Bridging the Gap From Postpartum to Primary Care N/A
Completed NCT00571766 - Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy Phase 3
Recruiting NCT05473767 - Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children N/A
Recruiting NCT05683093 - Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Completed NCT06403722 - Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
Recruiting NCT05852054 - Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP) Phase 3
Recruiting NCT05137808 - Understanding Blood Pressure Changes After Birth
Completed NCT03961360 - Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida Phase 2/Phase 3
Active, not recruiting NCT03648645 - Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure N/A
Recruiting NCT06054841 - Reshaping Postpartum Follow-up N/A