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Not Yet Recruiting NCT05726279

PROtecting Maternal Brains From Injury and Stroke

Conditions: Preeclampsia, Maternal Hypertension

Sex: Female
Ages: 18 Years – 55 Years
Phase: NA
Enrollment: 40
Sponsor: Columbia University

Location: United States

Summary

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.

Eligibility Criteria

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:measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart ORsevere headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen)Exclusion Criteria:Acute ischemic strokeAcute intracerebral or subarachnoid hemorrhage ·Eclamptic seizuresAny other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unitPrior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain diseaseHistory of Reynaud's syndrome (contraindication to finger plethysmography)Inability to understand and consent to the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05726279). StuddyBuddy aggregates publicly available trial information.