Clinical trial NCT05236725: Monitoring and Testing of Blood Pressure in Postpartum Women
Official title: Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: postpartum
blood pressure
women
blood pressure monitoring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 1602
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.

Detailed description: This is a randomized control trial (RCT). All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, NC that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART- BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit". This nurse home visit occurs via phone call, telehealth visit, or an in person visit \~2 weeks after delivery.

Eligibility criteria: Inclusion Criteria:

* Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC
* Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
* Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
* Currently resides in Forsyth County, NC
* 18 years of age or older
* Able to read and understand either English or Spanish
* Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Exclusion Criteria:

* Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
* Resides outside of Forsyth County, NC
* Under 18 years of age
* Unable to read or understand either English or Spanish
* Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Primary outcomes:
measure: Median number of rBPM measures obtained
timeFrame: Discharge through Week 3 postpartum
measure: Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines
timeFrame: Day 10 postpartum
measure: Median total cost of health care
timeFrame: From discharge through week 8 postpartum
measure: Median number of Severe Hypertension events
timeFrame: Discharge through week 1 postpartum
measure: Median number of Severe Hypertension events
timeFrame: Discharge through week 3 postpartum
measure: Median number of encounters for urgent or emergent care
timeFrame: Discharge through week 3 postpartum
Secondary outcomes:
measure: Median number of encounters for urgent or emergent care
timeFrame: Discharge through week 8 postpartum
measure: Acceptability of rBPM in postpartum period
timeFrame: Week 3 postpartum
measure: Median Length of Stay (LOS) in hospital after delivery
timeFrame: Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum
measure: Median number of hospital readmissions
timeFrame: Discharge through week 8 postpartum
measure: Median Length of Stay (LOS) for hospital readmissions
timeFrame: Discharge through week 8 postpartum
measure: Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery
timeFrame: Discharge through 12 months postpartum
Other outcomes:
measure: Validate and calibrate previously developed predictive algorithm
timeFrame: Discharge through week 8 postpartum
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Elizabeth T Jensen, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: