Gestational HypertensionPHANTOMNCT04823949
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
A study testing Home blood pressure monitoring in people with Gestational Hypertension and Preeclampsia, run by Prisma Health-Upstate at 2 sites in United States.
Trial summary
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth
- What is being tested?
- Home blood pressure monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2021to 18 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
- Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.
Who cannot join
- <18 years of age
- BMI >50 (due to limitations in blood pressure cuff size through BabyScripts)
- non English-speaking
- not able to receive phone calls and unlimited texts on cell phone
- not able to download and use Babyscripts phone application
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Greenville Memorial Hospital
Greenville, South Carolina, 29605
About this study
Official title: Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.
Read the detailed description
While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.
- Conditions
- Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome
- Being tested
- Home blood pressure monitoring
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood pressure monitoringDevice
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum |
| Intervention | Experimental | Patient will receive a Babyscripts blood pressure cuff(brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge Receives: Device: Home blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
Measured: 10 days
Secondary outcomes (4)
Initiation of Antihypertensive After Discharge
How many participants required initiation of antihypertensive after discharge
Measured: 16 days
Unscheduled Visits
Number of participants with unscheduled visits
Measured: 16 days
Readmission
Number of participants readmitted postpartum
Measured: 6 weeks
Attended Postpartum Visit
Number of participants who attended their postpartum visit
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Apr 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, South Carolina Telehealth Alliance, Babyscripts
- Responsible party
- Sponsor
- Investigators
- Renata Sawyer, MD, Principal investigator, Prisma Health-UpstateDavid Soper, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823949
- Sponsor's protocol ID
- Pro00090951
- Acronym
- PHANTOM
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2020
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Arkerson BJ, Finneran MM, Harris SR, Schnorr J, McElwee ER, Demosthenes L, Sawyer R. Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial. Obstet Gynecol. 2023 Oct 1;142(4):855-861. doi: 10.1097/AOG.0000000000005327. Epub 2023 Sep 7.
PubMed 37734091
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04823949
- Acronym / sponsor ID
- PHANTOM / Pro00090951
- Conditions
- Gestational Hypertension, Preeclampsia, Chronic Hypertension With Pre-Eclampsia Complicating Childbirth, HELLP Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, South Carolina Telehealth Alliance, Babyscripts
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.
Detailed description
While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum |
| Intervention | Experimental | Device: Home blood pressure monitoringPatient will receive a Babyscripts blood pressure cuff(brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
- Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.
Key exclusion criteria (5 listed)
- <18 years of age
- BMI >50 (due to limitations in blood pressure cuff size through BabyScripts)
- non English-speaking
- not able to receive phone calls and unlimited texts on cell phone
- not able to download and use Babyscripts phone application
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 |
|---|---|---|
| Home blood pressure monitoringSee arm description | Device | Intervention |
Primary outcome
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum
Time frame: 10 days
How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists
4 secondary outcomes
Initiation of Antihypertensive After Discharge
Time frame: 16 days
Unscheduled Visits
Time frame: 16 days
Readmission
Time frame: 6 weeks
Attended Postpartum Visit
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37734091Arkerson BJ, Finneran MM, Harris SR, Schnorr J, McElwee ER, Demosthenes L, Sawyer R. Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial. Obstet Gynecol. 2023 Oct 1;142(4):855-861. doi: 10.1097/AOG.0000000000005327. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No
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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.
Renata Sawyer, MD principal investigator
Prisma Health-Upstate
David Soper, MD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home blood pressure monitoring in people with Gestational Hypertension and Preeclampsia, run by Prisma Health-Upstate at 2 sites 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 2 inclusion and 5 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823949, which also lists 1 linked publication.
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 18 May 2023.