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

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Completed
CT.gov ID
NCT04823949
Collaborator
Medical University of South Carolina (Other), South Carolina Telehealth Alliance (Other), Babyscripts (Other)
150
Enrollment
2
Locations
2
Arms
5.5
Actual Duration (Months)
75
Patients Per Site
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New ACOG guidelines 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Home blood pressure monitoring
 N/A

Detailed Description

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 identification of severe blood pressures (>/= 160/100), adherence to ACOG guidelines for blood pressure monitoring, timing of the identification and treatment of severe blood pressures, readmissions, and patient satisfaction.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartumControl arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring
Actual Study Start Date :
Apr 15, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard care

Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum
Experimental: Intervention

Patient will receive a Babyscripts blood pressure cuff(brand: A&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge

Device: Home blood pressure monitoring
See arm description

Outcome Measures

Primary Outcome Measures

  1. Adherence to ACOG guideline of postpartum blood pressure check within 7-10 days postpartum [10 days]

Secondary Outcome Measures

  1. Treatment of severe range blood pressures [16 days]

    timing of the identification and treatment of severe blood pressures

  2. Readmissions [16 days]

    Number of readmissions in each arm

  3. Patient satisfaction via survey [21 days]

    Satisfaction of patients participating in each arm determined via survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 >40 (due to limitations in BP 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425
2 Greenville Memorial Hospital Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate
  • Medical University of South Carolina
  • South Carolina Telehealth Alliance
  • Babyscripts

Investigators

  • Principal Investigator: Renata Sawyer, MD, Prisma Health-Upstate
  • Principal Investigator: David Soper, MD, Medical University of South Carolina

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT04823949
Other Study ID Numbers:
  • Pro00090951
First Posted:
Apr 1, 2021
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
HELLP Syndrome
Hypertension

Study Results

No Results Posted as of May 12, 2022