N/A
Completed N=213
Remote BP Monitoring in the PP Period
Hypertensive Disorder of Pregnancy
Source: ClinicalTrials.gov NCT03728790 ↗
Enrolled (actual)
213
Serious AEs
9.4%
Results posted
Sep 2020
Primary outcomePrimary: Blood Pressure (BP) Surveillance Adherence — 0.0; 61.1 percentage of recommended BPs reported
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure (BP) Surveillance Adherence |
0.0; 61.1 | — |
| SECONDARY Total Percentage of Elevated Blood Pressure Readings |
37.52; 49.6 | — |
| SECONDARY Number of Participants With Outpatient BP Assessment Within 14 Days |
69; 59 | — |
| SECONDARY Percentage of Participants With Elevated BP After Discharge |
27.9; 24.5 | — |
| SECONDARY Number of Participants With Outpatient PP Assessment |
88; 82 | — |
| SECONDARY Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit |
13.6; 17.1 | — |
| SECONDARY Time to Medication Initiation |
6.5; 6.0 | — |
| SECONDARY Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge |
10; 24 | — |
| SECONDARY Number of Participants Readmitted |
7; 13 | — |
| SECONDARY Number of Participants With ED Visit |
17; 25 | — |
| SECONDARY Number of Participants Who Developed Preeclampsia-associated Complications |
4; 9 | — |
| SECONDARY Number of Participants Referred to Primary Care for Continued Blood Pressure Management |
31; 38 | — |
| SECONDARY Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) |
4.03 | — |
| SECONDARY Score on the Philips Program Start Survey and the Philips Program End Survey |
4.77; 4.57; 4.59; 4.55 | — |
| SECONDARY Communications |
0.12; 0.57 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03728790). 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. Informational only — not medical advice.