N/A
N=55
Postpartum Hypertension: Remote Patient Monitoring
Hypertension, Pregnancy-Induced
Bottom Line
View on ClinicalTrials.gov: NCT03111095 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Aim 1: Number of Participants Enrolled — 55 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile Health (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aim 1: Number of Participants Enrolled |
55 | — |
| PRIMARY Aim 1: Number of Participants Who Completed the Study |
52 | — |
| PRIMARY Aims 2-5: Number of Participants Enrolled in 1 Year |
214; 214 | — |
| PRIMARY Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions |
1; 8 | — |
| SECONDARY Aim 1: 6-week Hospital Readmission |
— | — |
| SECONDARY Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge |
9 | — |
| SECONDARY Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits |
6 | — |
| SECONDARY Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge |
29 | — |
| SECONDARY Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits |
10; 13 | — |
| SECONDARY Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery |
202; 129 | — |
| SECONDARY Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes |
57; 37 | — |
| SECONDARY Aims 2-5: Maximum Systolic Blood Pressure Intrapartum |
160; 158 | — |
| SECONDARY Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum |
101; 102 | — |
| SECONDARY Aims 2-5: Systolic Blood Pressure at Discharge |
131; 129 | — |
| SECONDARY Aims 2-5: Diastolic Blood Pressure at Discharge |
78; 78 | — |
| SECONDARY Aims 2-5: Medication at Discharge |
109; 72; 90; 61; 39; 20 | — |
| SECONDARY Aims 2-5: Postpartum Day of Discharge |
3.35; 2.92 | — |
| SECONDARY Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use |
186; 189 | — |
| SECONDARY Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery |
14.6; 14.4 | — |
| SECONDARY Self-Administered Questionnaire Satisfaction Survey Scores |
0.25; 0.59; 2.65; 3.33; 3.46; 0.16 | — |
| SECONDARY Participant Counts for Relevant SAQ Satisfaction Survey Questions |
24; 118; 11; 122; 5; 49 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03111095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.