Monitoring and Testing of Blood Pressure in Postpartum Women (NCT05236725) | Clinical Trial Compass
CompletedNot Applicable
Monitoring and Testing of Blood Pressure in Postpartum Women
United States1,607 participantsStarted 2022-03-01
Plain-language 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 blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women that received prenatal care at one of the Atrium Health Wake Forest Baptist Obstetrics/Maternal-Fetal Medicine outpatient clinic locations in Forsyth County, North Carolina
* 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, North Carolina
* 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, North Carolina
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant
Timeframe: Discharge through Week 3 postpartum
2
Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines
Timeframe: Discharge through Day 10 postpartum
3
Median Total Cost of Health Care
Timeframe: From discharge through week 8 postpartum
4
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
Timeframe: Discharge through week 1 postpartum
5
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
Timeframe: Discharge through week 3 postpartum
6
Number of Participants With One or More Urgent or Emergent Care Encounters