Hypertension in PregnancyNCT03613714
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
A study testing At-home Blood Pressure Monitoring in people with Hypertension in Pregnancy and Hypertension, Pregnancy-Induced, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Postpartum Preeclampsia
- What is being tested?
- At-home Blood Pressure Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Diagnosis of a hypertensive disorder of pregnancy (HDP)
- Chronic hypertension requiring medications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring
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.
Read the 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
- Being tested
- At-home Blood Pressure Monitoring
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home Blood Pressure MonitoringOther
Also called Digital Blood Pressure monitoring cuff
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-5 Days Post Hospital Discharge
Secondary outcomes (5)
Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery
Measured: 2 weeks from delivery
Percentage of participants readmitted within 2 weeks of delivery
Readmission, regardless of indication, within 2 weeks of delivery
Measured: 2 weeks of delivery
Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery
Measured: 2 weeks after delivery
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
Measured: Within 24 hours after BP evaluation
Percentage of attendance to recommended 4-to-6-week postpartum visit
Measured: Up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelica Glover, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613714
- Sponsor's protocol ID
- 18-0995
- Status last verified
- Mar 2020
- First submitted
- 25 Jul 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy: A Randomized Trial of Home- Versus Office-Based Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT03613714
- Acronym / sponsor ID
- 18-0995
- Conditions
- Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Blood Pressure Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: At-home Blood Pressure MonitoringAt-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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Diagnosis of a hypertensive disorder of pregnancy (HDP)
- Chronic hypertension requiring medications
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home Blood Pressure MonitoringAlso: Digital Blood Pressure monitoring cuffParticipants 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 | Intervention Group |
Primary outcome
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.
5 secondary outcomes
Percentage of participants readmitted for inpatient management of severe hypertension within 2 weeks of delivery
Time frame: 2 weeks from delivery
Percentage of participants readmitted within 2 weeks of delivery
Time frame: 2 weeks of delivery
Percentage of participants requiring OB triage evaluation for severe hypertension within 2 weeks of delivery
Time frame: 2 weeks after delivery
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
Percentage of attendance to recommended 4-to-6-week postpartum visit
Time frame: Up to 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelica Glover, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-home Blood Pressure Monitoring in people with Hypertension in Pregnancy and Hypertension, Pregnancy-Induced, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.