Clinical trial NCT03111095: Postpartum Hypertension: Remote Patient Monitoring
Official title: Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 428
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Aim 1: Number of Participants Enrolled
timeFrame: up to 3 months
measure: Aim 1: Number of Participants Who Completed the Study
timeFrame: up to 6 weeks
measure: Aims 2-5: Number of Participants Enrolled in 1 Year
timeFrame: up to 1 year
measure: Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
timeFrame: up to 6 weeks postpartum
Secondary outcomes:
measure: Aim 1: 6-week Hospital Readmission
timeFrame: up to 6 weeks
measure: Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge
timeFrame: up to 6 weeks
measure: Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits
timeFrame: up to 6 weeks postpartum
measure: Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge
timeFrame: up to 6 weeks
measure: Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits
timeFrame: up to 6 weeks postpartum
measure: Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery
timeFrame: up to 10 days of delivery
measure: Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes
timeFrame: up to 6 weeks postpartum
measure: Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
timeFrame: Admission to delivery (up to 96 hours)
measure: Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
timeFrame: Admission to delivery (up to 96 hours)
measure: Aims 2-5: Systolic Blood Pressure at Discharge
timeFrame: Up to 96 hours postpartum
measure: Aims 2-5: Diastolic Blood Pressure at Discharge
timeFrame: Up to 96 hours postpartum
measure: Aims 2-5: Medication at Discharge
timeFrame: up to 96 hours postpartum
measure: Aims 2-5: Postpartum Day of Discharge
timeFrame: up to 4.5 days
measure: Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
timeFrame: up to 4 days post-partum
measure: Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
timeFrame: first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy)
measure: Self-Administered Questionnaire Satisfaction Survey Scores
timeFrame: up to 6 weeks postpartum
measure: Participant Counts for Relevant SAQ Satisfaction Survey Questions
timeFrame: up to 6 weeks postpartum
Other outcomes:
measure: Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.
timeFrame: Up to 12 months
measure: Mode of Delivery
timeFrame: at delivery (on average 37-40 weeks of pregnancy)
measure: Neonatal Birthweight
timeFrame: at time of birth
measure: Neonatal Intensive Care Unit Admissions
timeFrame: at birth
Locations:
city: Madison
country: United States
facility: UnityPoint Health- Meriter Hospital
state: Wisconsin
Study officials:
affiliation: Clinical Assistant Professor
name: Kara Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available.
citation: Thomas NA, Drewry A, Racine Passmore S, Assad N, Hoppe KK. Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. BMC Pregnancy Childbirth. 2021 Feb 19;21(1):153. doi: 10.1186/s12884-021-03632-9.
citation: Hoppe KK, Williams M, Thomas N, Zella JB, Drewry A, Kim K, Havighurst T, Johnson HM. Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregnancy Hypertens. 2019 Jan;15:171-176. doi: 10.1016/j.preghy.2018.12.007. Epub 2018 Dec 31.