Preeclampsia Clinical Trial
— PROMISOfficial title:
PROtecting Maternal Brains From Injury and Stroke (PROMIS)
NCT number | NCT05726279 |
Other study ID # | AAAU3179 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2023 |
Est. completion date | December 31, 2024 |
The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (NIRS) monitoring for 24 hours. The interventional group will have personalized blood pressure targets according to results of NIRS monitoring which will be updated in real time.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks. - Admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features: 1. measured systolic BP =160 mmHg and/or diastolic BP =110 mmHg on two or more occasions, 15 minutes apart OR 2. severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen) Exclusion Criteria: - Acute ischemic stroke - Acute intracerebral or subarachnoid hemorrhage ยท - Eclamptic seizures - Any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit - Prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease - History of Reynaud's syndrome (contraindication to finger plethysmography) - Inability to understand and consent to the study |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time mean arterial pressure (MAP) is in the target range | The total time (in minutes) each participant had their mean arterial blood pressure (MAP) values within their computed limits of autoregulation will be measured. The primary outcome is the percentage of time the MAP is within the personalized limits of autoregulation. | 24 hours | |
Secondary | Number of participants with neurological symptoms | Number of participants with neurological symptoms. Neurological symptoms defined as =8/10 headache pain or blurred vision. | 24 hours | |
Secondary | Number of participants with physiological biomarker evidence of cerebral hypoperfusion | Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hypoperfusion will be defined as >13% decrease from baseline TOI. | 24 hours | |
Secondary | Number of participants with physiological biomarker evidence of cerebral hyperperfusion | Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hyperperfusion will be defined as a >2% increase from baseline TOI. | 24 hours |
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