PROtecting Maternal Brains From Injury and Stroke
Stopped early · Not applicable
Conditions studied: Preeclampsia, Maternal Hypertension
In brief
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.
Key facts
- Study ID
- NCT05726279
- Run by
- Columbia University
- People needed
- 26
- Starts
- 2023-05-04
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart OR
- severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen)
You may not qualify if…
- Acute ischemic stroke
- Acute intracerebral or subarachnoid hemorrhage ·
- 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
Where it is running
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP) — New York, New York, United States
Full record on ClinicalTrials.gov
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