Trial Outcomes & Findings for Postpartum Hypertension: Remote Patient Monitoring (NCT NCT03111095)

NCT ID: NCT03111095

Last Updated: 2025-08-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

428 participants

Primary outcome timeframe

up to 3 months

Results posted on

2025-08-22

Participant Flow

Between March 2017 and July 2017, 55 women were enrolled into a feasibility study for the intervention (Aim 1). Through June 2018, a total of 428 women were enrolled in this study (214 in the intervention group including those from Aim 1 and 214 in the control group). Participants were recruited from Meriter Hospital in Madison, WI.

Participant milestones

Participant milestones
Measure
Mobile Health Participants
Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. Participants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Feasibility and Satisfaction
STARTED
55
0
Aim 1: Feasibility and Satisfaction
Eligible Participants
263
0
Aim 1: Feasibility and Satisfaction
Participants Agreed to be Approached for Study
124
0
Aim 1: Feasibility and Satisfaction
Consented to Study
55
0
Aim 1: Feasibility and Satisfaction
COMPLETED
52
0
Aim 1: Feasibility and Satisfaction
NOT COMPLETED
3
0
Aims 2-5: Intervention
STARTED
214
214
Aims 2-5: Intervention
Number Analyzed
214
214
Aims 2-5: Intervention
COMPLETED
195
214
Aims 2-5: Intervention
NOT COMPLETED
19
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Mobile Health Participants
Participants used the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. Participants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Feasibility and Satisfaction
Withdrawal by Subject
3
0
Aims 2-5: Intervention
Withdrawal by Subject
19
0

Baseline Characteristics

Postpartum Hypertension: Remote Patient Monitoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. Participants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Total
n=428 Participants
Total of all reporting groups
Age, Continuous
31.4 years
STANDARD_DEVIATION 5.0 • n=5 Participants
31.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
31.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male
Female
214 Participants
n=5 Participants
214 Participants
n=7 Participants
428 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants
n=5 Participants
15 Participants
n=7 Participants
27 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
202 Participants
n=5 Participants
199 Participants
n=7 Participants
401 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Asian
10 Participants
n=5 Participants
12 Participants
n=7 Participants
22 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
16 Participants
n=5 Participants
25 Participants
n=7 Participants
41 Participants
n=5 Participants
Race (NIH/OMB)
White
175 Participants
n=5 Participants
168 Participants
n=7 Participants
343 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Region of Enrollment
United States
214 participants
n=5 Participants
214 participants
n=7 Participants
428 participants
n=5 Participants
Pre-pregnancy BMI
31.8 kg/m^2
n=5 Participants
30.6 kg/m^2
n=7 Participants
31.2 kg/m^2
n=5 Participants
Delivery BMI
37.4 kg/m^2
n=5 Participants
36.6 kg/m^2
n=7 Participants
37.0 kg/m^2
n=5 Participants
Primipara
108 Participants
n=5 Participants
91 Participants
n=7 Participants
199 Participants
n=5 Participants
Hypertension Classification
Chronic without Superimposed Preeclampsia
21 Participants
n=5 Participants
23 Participants
n=7 Participants
44 Participants
n=5 Participants
Hypertension Classification
Chronic with Superimposed Preeclampsia
22 Participants
n=5 Participants
23 Participants
n=7 Participants
45 Participants
n=5 Participants
Hypertension Classification
Gestational
62 Participants
n=5 Participants
79 Participants
n=7 Participants
141 Participants
n=5 Participants
Hypertension Classification
Preeclampsia
131 Participants
n=5 Participants
112 Participants
n=7 Participants
243 Participants
n=5 Participants
Other Subtypes of Hypertension of Interest
Mild Preeclampsia
51 Participants
n=5 Participants
63 Participants
n=7 Participants
114 Participants
n=5 Participants
Other Subtypes of Hypertension of Interest
Severe Preeclampsia
80 Participants
n=5 Participants
49 Participants
n=7 Participants
129 Participants
n=5 Participants
Other Subtypes of Hypertension of Interest
Hemolysis Elevated Liver enzyme Low Platelet (HELLP)
11 Participants
n=5 Participants
1 Participants
n=7 Participants
12 Participants
n=5 Participants
Other Subtypes of Hypertension of Interest
Eclampsia
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Married
163 Participants
n=5 Participants
149 Participants
n=7 Participants
312 Participants
n=5 Participants
Tobacco Use
12 Participants
n=5 Participants
21 Participants
n=7 Participants
33 Participants
n=5 Participants
Insurance Status
Private
185 Participants
n=5 Participants
157 Participants
n=7 Participants
342 Participants
n=5 Participants
Insurance Status
Medicaid
29 Participants
n=5 Participants
57 Participants
n=7 Participants
86 Participants
n=5 Participants
Pre-gestational Diabetes Mellitus
10 Participants
n=5 Participants
13 Participants
n=7 Participants
23 Participants
n=5 Participants
Gestational age at delivery
Preterm (less than 37 weeks)
57 Participants
n=5 Participants
42 Participants
n=7 Participants
99 Participants
n=5 Participants
Gestational age at delivery
Term (greater than or equal to 37 weeks)
157 Participants
n=5 Participants
172 Participants
n=7 Participants
329 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 3 months

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Number of Participants Enrolled
55 Participants

PRIMARY outcome

Timeframe: up to 6 weeks

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Number of Participants Who Completed the Study
52 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Number of Participants Enrolled in 1 Year
214 Participants
214 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
1 Participants
8 Participants

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: 6-week Hospital Readmission
0 Participants

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge
9 Participants

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits
6 Participants

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.

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

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge
29 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits
10 Participants
13 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery
202 Participants
129 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes
57 Participants
37 Participants

SECONDARY outcome

Timeframe: Admission to delivery (up to 96 hours)

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
160 mmHg
Interval 152.0 to 171.0
158 mmHg
Interval 151.0 to 167.0

SECONDARY outcome

Timeframe: Admission to delivery (up to 96 hours)

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
101 mmHg
Interval 96.0 to 110.0
102 mmHg
Interval 96.0 to 109.0

SECONDARY outcome

Timeframe: Up to 96 hours postpartum

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Systolic Blood Pressure at Discharge
131 mmHg
Interval 124.0 to 138.0
129 mmHg
Interval 121.0 to 136.0

SECONDARY outcome

Timeframe: Up to 96 hours postpartum

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Diastolic Blood Pressure at Discharge
78 mmHg
Interval 72.0 to 84.0
78 mmHg
Interval 71.0 to 84.0

SECONDARY outcome

Timeframe: up to 96 hours postpartum

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Medication at Discharge
Any Antihypertensive
109 Participants
72 Participants
Aims 2-5: Medication at Discharge
Labetalol
90 Participants
61 Participants
Aims 2-5: Medication at Discharge
Nifedipine
39 Participants
20 Participants

SECONDARY outcome

Timeframe: up to 4.5 days

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Postpartum Day of Discharge
3.35 days
Standard Deviation 1.2
2.92 days
Standard Deviation 1.1

SECONDARY outcome

Timeframe: up to 4 days post-partum

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
186 Participants
189 Participants

SECONDARY outcome

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

Population: Number of participants for which both first prenatal care weight and delivery weight were measured.

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=212 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=210 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
14.6 kilograms
Standard Deviation 8.0
14.4 kilograms
Standard Deviation 8.4

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Population: Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.

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.

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=128 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Self-Administered Questionnaire Satisfaction Survey Scores
How easy was it to get help?
3.33 score on a scale
Standard Deviation 0.87
Self-Administered Questionnaire Satisfaction Survey Scores
How satisfied are you with the mHealth devices?
3.32 score on a scale
Standard Deviation 0.83
Self-Administered Questionnaire Satisfaction Survey Scores
To what extent does using the mHealth tech make you feel safer?
2.86 score on a scale
Standard Deviation 0.96
Self-Administered Questionnaire Satisfaction Survey Scores
How secure do you feel submitting your vitals?
3.41 score on a scale
Standard Deviation 0.76
Self-Administered Questionnaire Satisfaction Survey Scores
How much more in control of your own health do you feel?
2.91 score on a scale
Standard Deviation 0.9
Self-Administered Questionnaire Satisfaction Survey Scores
How much more aware of your own health do you feel?
3.30 score on a scale
Standard Deviation 0.74
Self-Administered Questionnaire Satisfaction Survey Scores
Do you prefer going to clinic/hospital instead of using mHealth for postpartum follow-up?
0.31 score on a scale
Standard Deviation 0.78
Self-Administered Questionnaire Satisfaction Survey Scores
How much would you recommend mHealth to others in your situation?
3.49 score on a scale
Standard Deviation 0.79
Self-Administered Questionnaire Satisfaction Survey Scores
How enjoyable are the mHealth devices to use?
2.41 score on a scale
Standard Deviation 1.06
Self-Administered Questionnaire Satisfaction Survey Scores
How complicated are mHealth's instructions?
0.25 score on a scale
Standard Deviation 0.67
Self-Administered Questionnaire Satisfaction Survey Scores
How much mental effort does mHealth require?
0.59 score on a scale
Standard Deviation 0.74
Self-Administered Questionnaire Satisfaction Survey Scores
How easily does mHealth fit into your lifestyle?
2.65 score on a scale
Standard Deviation 0.96
Self-Administered Questionnaire Satisfaction Survey Scores
How confident do you feel using the mHealth devices?
3.46 score on a scale
Standard Deviation 0.79
Self-Administered Questionnaire Satisfaction Survey Scores
How hard is the monitor to use?
0.16 score on a scale
Standard Deviation 0.49
Self-Administered Questionnaire Satisfaction Survey Scores
How organized is the monitor?
3.27 score on a scale
Standard Deviation 0.78
Self-Administered Questionnaire Satisfaction Survey Scores
How helpful are the monitor's prompts?
2.57 score on a scale
Standard Deviation 1.34
Self-Administered Questionnaire Satisfaction Survey Scores
How easy is the blood pressure cuff to use?
3.44 score on a scale
Standard Deviation 0.79
Self-Administered Questionnaire Satisfaction Survey Scores
How hard is the weight scale to use?
0.37 score on a scale
Standard Deviation 1.06
Self-Administered Questionnaire Satisfaction Survey Scores
How reasonable is the amount of time it takes to record your blood pressure?
3.46 score on a scale
Standard Deviation 0.77
Self-Administered Questionnaire Satisfaction Survey Scores
How reasonable is the amount of time it takes to record your weight?
3.47 score on a scale
Standard Deviation 0.79
Self-Administered Questionnaire Satisfaction Survey Scores
How burdensome is it to record your blood pressure daily?
0.85 score on a scale
Standard Deviation 0.93
Self-Administered Questionnaire Satisfaction Survey Scores
How burdensome is it to record your weight daily?
0.78 score on a scale
Standard Deviation 0.98
Self-Administered Questionnaire Satisfaction Survey Scores
How often do you feel unsafe while using mHealth?
0.38 score on a scale
Standard Deviation 1.06
Self-Administered Questionnaire Satisfaction Survey Scores
How fun is answering questions using the Genesis Touch Monitor?
2.24 score on a scale
Standard Deviation 1.03
Self-Administered Questionnaire Satisfaction Survey Scores
Did the Genesis Touch Monitor have all functions you expected?
3.02 score on a scale
Standard Deviation 0.98
Self-Administered Questionnaire Satisfaction Survey Scores
Do you like the touch screen technology on the Genesis Touch monitor?
3.43 score on a scale
Standard Deviation 0.74
Self-Administered Questionnaire Satisfaction Survey Scores
Does using mHealth make you worry more, less or the same?
1.23 score on a scale
Standard Deviation 0.63

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Population: Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.

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.

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=128 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had a hospital readmission
3 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who got help for problems with their devices
24 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 1 minute to measure their blood pressure
118 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 5 minutes to measure their blood pressure
11 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 1 minute to measure their weight
122 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 5 minutes to measure their weight
5 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participant who had any problems using the Genesis Touch monitor
49 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had any problems using the blood pressure cuff
108 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had any problems using the scale
107 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had concerns sending their vitals to their health care provider
4 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had enough control over their data
113 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participant who had to go to an emergency room after discharge
14 Participants
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who went to a different hospital than their delivery hospital
1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Mode of Delivery
Vaginal spontaneous
84 Participants
112 Participants
Mode of Delivery
Cesarean
114 Participants
87 Participants
Mode of Delivery
Operative vaginal
16 Participants
15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of birth

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Neonatal Birthweight
3180 grams
Interval 2660.0 to 3540.0
3060 grams
Interval 2610.0 to 3490.0

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

Outcome measures

Outcome measures
Measure
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Neonatal Intensive Care Unit Admissions
67 Participants
55 Participants

Adverse Events

Mobile Health Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kara Hoppe, DO

University of Wisconsin School of Medicine and Public Health

Phone: (206) 371-4014

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place