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Completed

NCT Number: NCT03728790

Remote BP Monitoring in the PP Period

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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Infections Pre-Eclampsia Pregnancy Complications Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Remote Patient Monitoring

Device

Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Primary outcomes

  1. 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

Secondary outcomes

  1. Total Percentage of Elevated Blood Pressure Readings

    Time frame: Up to 14 days from delivery hospitalization discharge

    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).

  2. Number of Participants With Outpatient BP Assessment Within 14 Days

    Time frame: Up to 14 days from delivery hospitalization discharge

    Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home)

  3. Percentage of Participants With Elevated BP After Discharge

    Time frame: Up to 14 days from delivery hospitalization discharge

    Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at outpatient blood pressure assessment

  4. Number of Participants With Outpatient PP Assessment

    Time frame: Up to 8 weeks from delivery

    Number of participants who had an outpatient postpartum (PP) assessment

  5. Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit

    Time frame: Up to 8 weeks from delivery

    Incidence of elevated blood pressure (>140 systolic or >90 diastolic) at the postpartum visit

  6. Time to Medication Initiation

    Time frame: Up to 8 weeks from delivery

    Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)

  7. Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge

    Time frame: Up to 8 weeks from delivery

    Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy

  8. Number of Participants Readmitted

    Time frame: Up to 8 weeks from delivery

    Number of participants who were readmitted after delivery hospitalization discharge

  9. Number of Participants With ED Visit

    Time frame: Up to 8 weeks from delivery

    Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge

  10. Number of Participants Who Developed Preeclampsia-associated Complications

    Time frame: Up to 8 weeks from delivery

    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.

  11. Number of Participants Referred to Primary Care for Continued Blood Pressure Management

    Time frame: Up to 8 weeks from delivery

    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

  12. Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)

    Time frame: Up to 8 weeks from delivery

    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.

  13. Score on the Philips Program Start Survey and the Philips Program End Survey

    Time frame: Baseline, program end (up to 8 weeks from delivery)

    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.

  14. Communications

    Time frame: Up to 14 days post delivery hospitalization discharge

    Number of communications between patient and obstetric provider

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • New York Presbyterian Hospital
  • Philips Healthcare

Registry information

Official study title

A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 2, 2018
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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