Hypertensive Disorder of PregnancyNCT03728790
Remote BP Monitoring in the PP Period
A study testing Remote Patient Monitoring in people with Hypertensive Disorder of Pregnancy, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 11 May 2020
- 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
- Postpartum women
- Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
- At least 18 years of age
- English or Spanish speakers
Who cannot join
- Non-English or Spanish speakers
- Women who are not planning on obtaining their postpartum follow up at CUIMC
- Women who are physically unable to hold or use the tablet
- Women who do not have a working phone
- Provider unwilling or unable to set up escalation pathway
- Women who reside outside of New York State
- Hypertension diagnosed postpartum
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.
Read the detailed description
Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.
- Conditions
- Hypertensive Disorder of Pregnancy
- Being tested
- Remote Patient Monitoring
- Keywords
- hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP
- Medical subject headings
- Toxemia, Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringDevice
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit. |
| Remote Patient Monitoring | Experimental | Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit. Receives: Device: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP) Surveillance Adherence
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Measured: Up to 14 days from delivery hospitalization discharge
Secondary outcomes (14)
Total Percentage of Elevated Blood Pressure Readings
Of all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as >/=140 systolic or >/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first).
Measured: Up to 14 days from delivery hospitalization discharge
Number of Participants With Outpatient BP Assessment Within 14 Days
Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home)
Measured: Up to 14 days from delivery hospitalization discharge
Percentage of Participants With Elevated BP After Discharge
Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at outpatient blood pressure assessment
Measured: Up to 14 days from delivery hospitalization discharge
Number of Participants With Outpatient PP Assessment
Number of participants who had an outpatient postpartum (PP) assessment
Measured: Up to 8 weeks from delivery
Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit
Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at the postpartum visit
Measured: Up to 8 weeks from delivery
Time to Medication Initiation
Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
Measured: Up to 8 weeks from delivery
Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Measured: Up to 8 weeks from delivery
Number of Participants Readmitted
Number of participants who were readmitted after delivery hospitalization discharge
Measured: Up to 8 weeks from delivery
Number of Participants With ED Visit
Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Measured: Up to 8 weeks from delivery
Number of Participants Who Developed Preeclampsia-associated Complications
Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.
Measured: Up to 8 weeks from delivery
Number of Participants Referred to Primary Care for Continued Blood Pressure Management
Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit
Measured: Up to 8 weeks from delivery
Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
Measured: Up to 8 weeks from delivery
Score on the Philips Program Start Survey and the Philips Program End Survey
The Philips program start survey is a 4-question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6-question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The number reported is the average score for each group.
Measured: Baseline, program end (up to 8 weeks from delivery)
Communications
Number of communications between patient and obstetric provider
Measured: Up to 14 days post delivery hospitalization discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start9 Nov 2018
- Primary completion28 Jul 2019
- Study completion11 May 2020
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 (20)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial with 2 arms
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, New York Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Leslie Moroz, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728790
- Sponsor's protocol ID
- AAAS0065
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2018
- Last updated
- 1 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PubMed 24150027Goel A, Maski MR, Bajracharya S, Wenger JB, Zhang D, Salahuddin S, Shahul SS, Thadhani R, Seely EW, Karumanchi SA, Rana S. Epidemiology and Mechanisms of De Novo and Persistent Hypertension in the Postpartum Period. Circulation. 2015 Nov 3;132(18):1726-33. doi: 10.1161/CIRCULATIONAHA.115.015721. Epub 2015 Sep 28.
PubMed 26416810Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
PubMed 25560097Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.
PubMed 27583396Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
PubMed 16807794Albini F, Xiaoqiu Liu, Torlasco C, Soranna D, Faini A, Ciminaghi R, Celsi A, Benedetti M, Zambon A, di Rienzo M, Parati G. An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. doi: 10.1109/EMBC.2016.7590753.
PubMed 28324932Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
PubMed 21963308Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
PubMed 3769407Clark SL, Belfort MA, Dildy GA, Englebright J, Meints L, Meyers JA, Frye DK, Perlin JA. Emergency department use during the postpartum period: implications for current management of the puerperium. Am J Obstet Gynecol. 2010 Jul;203(1):38.e1-6. doi: 10.1016/j.ajog.2010.02.033. Epub 2010 Apr 24.
PubMed 20417492Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
PubMed 27829570Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-1107. doi: 10.1097/AOG.0b013e318231934c.
PubMed 21979459Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Pina IL, Reeves MJ, Rexrode KM, Saposnik G, Singh V, Towfighi A, Vaccarino V, Walters MR; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 May;45(5):1545-88. doi: 10.1161/01.str.0000442009.06663.48. Epub 2014 Feb 6.
PubMed 24503673Wenger NK, Arnold A, Bairey Merz CN, Cooper-DeHoff RM, Ferdinand KC, Fleg JL, Gulati M, Isiadinso I, Itchhaporia D, Light-McGroary K, Lindley KJ, Mieres JH, Rosser ML, Saade GR, Walsh MN, Pepine CJ. Hypertension Across a Woman's Life Cycle. J Am Coll Cardiol. 2018 Apr 24;71(16):1797-1813. doi: 10.1016/j.jacc.2018.02.033.
PubMed 29673470Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.
PubMed 29703800Tully KP, Stuebe AM, Verbiest SB. The fourth trimester: a critical transition period with unmet maternal health needs. Am J Obstet Gynecol. 2017 Jul;217(1):37-41. doi: 10.1016/j.ajog.2017.03.032. Epub 2017 Apr 5.
PubMed 28390671
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03728790
- Acronym / sponsor ID
- AAAS0065
- Conditions
- Hypertensive Disorder of Pregnancy
- Keywords
- hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Philips Healthcare, New York Presbyterian Hospital
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 28 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.
Detailed description
Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial with 2 arms
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit. |
| Remote Patient Monitoring | Experimental | Device: Remote Patient MonitoringRemote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum women
- Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
- At least 18 years of age
- English or Spanish speakers
Key exclusion criteria (7 listed)
- Non-English or Spanish speakers
- Women who are not planning on obtaining their postpartum follow up at CUIMC
- Women who are physically unable to hold or use the tablet
- Women who do not have a working phone
- Provider unwilling or unable to set up escalation pathway
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 |
|---|---|---|
| Remote Patient MonitoringBluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period. | Device | Remote Patient Monitoring |
Primary outcome
Blood Pressure (BP) Surveillance Adherence
Time frame: Up to 14 days from delivery hospitalization discharge
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
14 secondary outcomes
Total Percentage of Elevated Blood Pressure Readings
Time frame: Up to 14 days from delivery hospitalization discharge
Number of Participants With Outpatient BP Assessment Within 14 Days
Time frame: Up to 14 days from delivery hospitalization discharge
Percentage of Participants With Elevated BP After Discharge
Time frame: Up to 14 days from delivery hospitalization discharge
Number of Participants With Outpatient PP Assessment
Time frame: Up to 8 weeks from delivery
Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit
Time frame: Up to 8 weeks from delivery
Time to Medication Initiation
Time frame: Up to 8 weeks from delivery
Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
Time frame: Up to 8 weeks from delivery
Number of Participants Readmitted
Time frame: Up to 8 weeks from delivery
Number of Participants With ED Visit
Time frame: Up to 8 weeks from delivery
Number of Participants Who Developed Preeclampsia-associated Complications
Time frame: Up to 8 weeks from delivery
Number of Participants Referred to Primary Care for Continued Blood Pressure Management
Time frame: Up to 8 weeks from delivery
Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
Time frame: Up to 8 weeks from delivery
Score on the Philips Program Start Survey and the Philips Program End Survey
Time frame: Baseline, program end (up to 8 weeks from delivery)
Communications
Time frame: Up to 14 days post delivery hospitalization discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24150027Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Background: PubMed 26416810Goel A, Maski MR, Bajracharya S, Wenger JB, Zhang D, Salahuddin S, Shahul SS, Thadhani R, Seely EW, Karumanchi SA, Rana S. Epidemiology and Mechanisms of De Novo and Persistent Hypertension in the Postpartum Period. Circulation. 2015 Nov 3;132(18):1726-33. doi: 10.1161/CIRCULATIONAHA.115.015721. Epub 2015 Sep 28.
- Background: PubMed 25560097Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
- Background: PubMed 27583396Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.
- Background: PubMed 16807794Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
- Background: PubMed 28324932Albini F, Xiaoqiu Liu, Torlasco C, Soranna D, Faini A, Ciminaghi R, Celsi A, Benedetti M, Zambon A, di Rienzo M, Parati G. An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:517-520. doi: 10.1109/EMBC.2016.7590753.
- Background: PubMed 21963308Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
- Background: PubMed 3769407Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
- Background: PubMed 20417492Clark SL, Belfort MA, Dildy GA, Englebright J, Meints L, Meyers JA, Frye DK, Perlin JA. Emergency department use during the postpartum period: implications for current management of the puerperium. Am J Obstet Gynecol. 2010 Jul;203(1):38.e1-6. doi: 10.1016/j.ajog.2010.02.033. Epub 2010 Apr 24.
- Background: PubMed 27829570Clapp MA, Little SE, Zheng J, Robinson JN. A multi-state analysis of postpartum readmissions in the United States. Am J Obstet Gynecol. 2016 Jul;215(1):113.e1-113.e10. doi: 10.1016/j.ajog.2016.01.174.
- Background: PubMed 21979459Al-Safi Z, Imudia AN, Filetti LC, Hobson DT, Bahado-Singh RO, Awonuga AO. Delayed postpartum preeclampsia and eclampsia: demographics, clinical course, and complications. Obstet Gynecol. 2011 Nov;118(5):1102-1107. doi: 10.1097/AOG.0b013e318231934c.
- Background: PubMed 24503673Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, Howard VJ, Lichtman JH, Lisabeth LD, Pina IL, Reeves MJ, Rexrode KM, Saposnik G, Singh V, Towfighi A, Vaccarino V, Walters MR; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 May;45(5):1545-88. doi: 10.1161/01.str.0000442009.06663.48. Epub 2014 Feb 6.
- 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.
Leslie Moroz, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in people with Hypertensive Disorder of Pregnancy, run by Columbia University 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 4 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 1 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2020). 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?
Blood Pressure (BP) Surveillance Adherence (time frame: Up to 14 days from delivery hospitalization discharge). 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 NCT03728790, which also lists 20 linked publications.
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 1 Jan 2025.