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OpenTrials
Completed

NCT Number: NCT04823949

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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About this study

While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
  • Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.

Exclusion criteria

  • <18 years of age
  • BMI >50 (due to limitations in blood pressure cuff size through BabyScripts)
  • non English-speaking
  • not able to receive phone calls and unlimited texts on cell phone
  • not able to download and use Babyscripts phone application

Treatment and study plan

Home blood pressure monitoring

Device

See arm description

Primary outcomes

  1. Adherence to the American College of Obstetricians and Gynecologists Guideline of Postpartum Blood Pressure Check Within 10 Days Postpartum

    Time frame: 10 days

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

Secondary outcomes

  1. Initiation of Antihypertensive After Discharge

    Time frame: 16 days

    How many participants required initiation of antihypertensive after discharge

  2. Unscheduled Visits

    Time frame: 16 days

    Number of participants with unscheduled visits

  3. Readmission

    Time frame: 6 weeks

    Number of participants readmitted postpartum

  4. Attended Postpartum Visit

    Time frame: 6 weeks

    Number of participants who attended their postpartum visit

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Babyscripts
  • Medical University of South Carolina
  • South Carolina Telehealth Alliance

Registry information

Official study title

Remote Monitoring Compared With In-Office Surveillance of Blood Pressures in Patients With Pregnancy-Related Hypertension: A Randomized Controlled Trial

Acronym: PHANTOM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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