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Personalized Blood Pressure Management for Postpartum Preeclampsia (PROMIS Trial)
N/A
Recruiting
Led By Eliza Miller, MD, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
PROMIS Trial Summary
This trial tests a new approach to blood pressure management in postpartum preeclampsia with personalized targets and 24h monitoring. Standard medications will be used.
Who is the study for?
This trial is for women aged 18 or older who are within 6 weeks postpartum after a pregnancy of at least 20 weeks and have been admitted for preeclampsia treatment. Eligible participants must have high blood pressure readings or severe headaches not relieved by over-the-counter meds. Women with recent brain injuries, strokes, seizures, certain neurological diseases, eclamptic seizures, or Reynaud's syndrome cannot participate.Check my eligibility
What is being tested?
The study tests a new method to manage blood pressure in women with postpartum preeclampsia using standard medications alongside NIRS monitoring. Participants will be split into two groups: one receiving personalized blood pressure targets based on real-time NIRS data and the other undergoing regular care without personalized targets.See study design
What are the potential side effects?
Since this trial uses standard blood pressure medications already used in clinical practice, side effects may include dizziness, headache, fatigue, nausea and others typically associated with these drugs. The NIRS monitoring itself is non-invasive and generally does not cause side effects.
PROMIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time mean arterial pressure (MAP) is in the target range
Secondary outcome measures
Number of participants with neurological symptoms
Number of participants with physiological biomarker evidence of cerebral hyperperfusion
Number of participants with physiological biomarker evidence of cerebral hypoperfusion
PROMIS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionalExperimental Treatment1 Intervention
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
Group II: Observational CohortActive Control1 Intervention
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,923 Total Patients Enrolled
Eliza Miller, MD, MSPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and can consent to the study.I have had a stroke, seizures, brain injury, brain surgery, encephalitis, or a demyelinating brain disease.I have had a recent brain bleed.I have had a recent stroke caused by a blood clot.I have had seizures due to eclampsia.I am over 18 and have given birth within the last 6 weeks.I have had a neurological issue that needed intensive care.I am hospitalized for severe preeclampsia with high blood pressure or persistent headaches.
Research Study Groups:
This trial has the following groups:- Group 1: Observational Cohort
- Group 2: Interventional
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 or more being included in the research?
"The minimum age requirement for participants in this medical study is 18 and the maximum age to be eligible is 55."
Answered by AI
Could I be eligible to enroll in this experiment?
"To be considered for this medical study, applicants must have prophylaxis of preeclampsia and fall between the ages 18-55. To facilitate research goals, 40 participants are being recruited."
Answered by AI
Are there vacancies for volunteers in this experiment?
"Clinicaltrials.gov indicates that this trial is not actively recruiting patients at present, despite it being initially published on March 1st 2023 and last updated in February 3rd 2023. Nonetheless, there are 86 other trials currently looking for participants."
Answered by AI
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