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Completed

NCT Number: NCT03111095

Postpartum Hypertension: Remote Patient Monitoring

The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System (mobile health) can improve patient satisfaction and quality of care provided to women experiencing complications due to high blood pressure during pregnancy.

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Key information

Conditions

Hypertension, Pregnancy-Induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, 53715, United States

About this study

For six weeks postpartum, patients will use Honeywell Genesis Android Touch Bluetooth System to record and submit their daily blood pressure and weight measurements to a mobile health nurse and research team. Subjects will be provided with the kit (Honeywell tablet, mobile hot spot, blood pressure cuff, and scale) at no cost. Subjects will participate in video telehealth visits at 48 hours and 7 days after discharge to help provide management for hypertension related issues.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia diagnosed in the antenatal (primary admission for delivery of the baby (planned or due to hypertension) or postpartum period as determined by systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 on two occasions 4 hours apart.
  • Gestational age at time of delivery greater than 23 weeks gestation
  • Postpartum with persistent SBP greater than 140 or DBP greater than 90 on two occasions 4 hours apart (to enroll would be prior to discharge from initial postpartum hospital stay).
  • Primary hospital admission for the delivery of the neonate(s).

Exclusion criteria

  • Inability to obtain informed consent

Treatment and study plan

Mobile Health

Other

Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.

Primary outcomes

  1. Aim 1: Number of Participants Enrolled

    Time frame: up to 3 months

    A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.

  2. Aim 1: Number of Participants Who Completed the Study

    Time frame: up to 6 weeks

    To assess retention, the number of participants who completed the study will be reported.

  3. Aims 2-5: Number of Participants Enrolled in 1 Year

    Time frame: up to 1 year

    Aims 2-5 primary endpoint is enrollment of up to 40 participants at all times (for a total of 42 days) over one year (220 experimental and 220 matched controls for chart review).

  4. Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions

    Time frame: up to 6 weeks postpartum

    Comparison of hypertension-related hospital readmissions between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with hypertensive disorders of pregnancy (HDP).

Secondary outcomes

  1. Aim 1: 6-week Hospital Readmission

    Time frame: up to 6 weeks

  2. Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge

    Time frame: up to 6 weeks

    Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)

  3. Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits

    Time frame: up to 6 weeks postpartum

    Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).

  4. Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge

    Time frame: up to 6 weeks

    Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).

  5. Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits

    Time frame: up to 6 weeks postpartum

    Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).

  6. Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery

    Time frame: up to 10 days of delivery

    Comparison of number of participants with at least one blood pressure review within 10 days of delivery between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).

  7. Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes

    Time frame: up to 6 weeks postpartum

    Comparison of number of participants on antihypertensive treatments between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).

  8. Aims 2-5: Maximum Systolic Blood Pressure Intrapartum

    Time frame: Admission to delivery (up to 96 hours)

  9. Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum

    Time frame: Admission to delivery (up to 96 hours)

  10. Aims 2-5: Systolic Blood Pressure at Discharge

    Time frame: Up to 96 hours postpartum

  11. Aims 2-5: Diastolic Blood Pressure at Discharge

    Time frame: Up to 96 hours postpartum

  12. Aims 2-5: Medication at Discharge

    Time frame: up to 96 hours postpartum

  13. Aims 2-5: Postpartum Day of Discharge

    Time frame: up to 4.5 days

  14. Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use

    Time frame: up to 4 days post-partum

  15. Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery

    Time frame: first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy)

  16. Self-Administered Questionnaire Satisfaction Survey Scores

    Time frame: up to 6 weeks postpartum

    In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of mean scores (1-5) are reported here.

  17. Participant Counts for Relevant SAQ Satisfaction Survey Questions

    Time frame: up to 6 weeks postpartum

    In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of questions with participant counts is reported here.

Other outcomes

  1. Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.

    Time frame: Up to 12 months

    Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy.

  2. Mode of Delivery

    Time frame: at delivery (on average 37-40 weeks of pregnancy)

  3. Neonatal Birthweight

    Time frame: at time of birth

  4. Neonatal Intensive Care Unit Admissions

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
Aug 22, 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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