Last reviewed · How we verify

NCT04823949: PHANTOM

Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring

Completed NA Results posted Last updated 18 May 2023
What this trial tests

NA trial testing Home blood pressure monitoring in Gestational Hypertension in 202 participants. Completed in 18 January 2022.

Timeline
15 April 2021
Primary endpoint
18 January 2022
18 January 2022

Quick facts

Lead sponsorPrisma Health-Upstate
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment202
Start date15 April 2021
Primary completion18 January 2022
Estimated completion18 January 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Prisma Health-Upstate — full company profile →

Who can join

18 and older, female only, with Gestational Hypertension or Preeclampsia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum Primary · 10 days

How many participants had a blood pressure check within 10 days postpartum as recommended by the American College of Obstetricians and Gynecologists

GroupValue95% CI
Standard Care59
Intervention89
Initiation of Antihypertensive After Discharge Secondary · 16 days

How many participants required initiation of antihypertensive after discharge

GroupValue95% CI
Standard Care7
Intervention9
Unscheduled Visits Secondary · 16 days

Number of participants with unscheduled visits

GroupValue95% CI
Standard Care5
Intervention12
Readmission Secondary · 6 weeks

Number of participants readmitted postpartum

GroupValue95% CI
Standard Care5
Intervention4
Attended Postpartum Visit Secondary · 6 weeks

Number of participants who attended their postpartum visit

GroupValue95% CI
Standard Care71
Intervention75

Sponsor's own description

A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Remote Monitoring Compared With In-Office Surveillance of Blood Pressure in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial.
    Arkerson BJ, Finneran MM, Harris SR, Schnorr J, et al · · 2023 · cited 27× · PMID 37734091 · DOI 10.1097/aog.0000000000005327

Verify or expand the search:

Other trials of Home blood pressure monitoring

Trials testing the same drug.

Other recruiting trials for Gestational Hypertension

Currently open trials in the same condition.

Other Prisma Health-Upstate trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04823949.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing